<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03034863</url>
  </required_header>
  <id_info>
    <org_study_id>D2432-R</org_study_id>
    <secondary_id>RX002432-01</secondary_id>
    <nct_id>NCT03034863</nct_id>
  </id_info>
  <brief_title>SAFER: A Brief Intervention Involving Family Members in Suicide Safety Planning</brief_title>
  <acronym>SAFER</acronym>
  <official_title>SAFER: A Brief Intervention Involving Family Members in Suicide Safety Planning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The management of suicide risk is a pressing national public health issue especially among&#xD;
      Veterans, and there exist no guidelines of how best to involve family members in this effort.&#xD;
      This proposal will integrate family and couples communication skills training with suicide&#xD;
      safety planning. The goal is for the sharing of Veteran suicide safety plans with family&#xD;
      members and the construction of a parallel family member safety plan, in efforts to mobilize&#xD;
      and support family involvement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Psychological models of suicidality emphasize the role of social factors in the development&#xD;
      and intensification of suicidal thoughts and behavior, including feeling like a burden on&#xD;
      family and friends, feelings of isolation and not belonging, and perceptions of diminished&#xD;
      support from one's family and social network. Despite the critical role of family factors in&#xD;
      protecting against suicidality, families lack education on how their behavior can help avert&#xD;
      or unwittingly aggravate suicidal thoughts/ behavior. Families worry about their relative but&#xD;
      feel uncertain of how to help and need professional guidance. Family worries about&#xD;
      suicidality are associated with compromised family physical and mental health and&#xD;
      consequently, diminished ability to offer needed support. Because suicide safety plans rely&#xD;
      on mobilizing support in times of crisis, families need to be equipped to provide needed&#xD;
      support.&#xD;
&#xD;
      Family recommendations from the VA Behavioral Health Autopsy Program (BHAP) Annual Report&#xD;
      6/30/15 based on interviews with 114 family members highlighted the importance of:&#xD;
&#xD;
        1. educating families about suicide warning signs:&#xD;
&#xD;
        2. improving communication between the veteran and family member&#xD;
&#xD;
        3. involving the family in the veterans' treatment to enhance support and trust&#xD;
&#xD;
        4. providing families with coaching on how to assist their loved one to seek help.&#xD;
&#xD;
      Management of suicidal behavior is covered in comprehensive family psychoeducation programs,&#xD;
      but there is an urgent need for a brief family-based intervention specifically focused on&#xD;
      suicide prevention that can be used in conjunction with the currently mandated SSP and as a&#xD;
      part of routine care.&#xD;
&#xD;
      Despite the enrichment of VA suicide prevention services and implementation of the national&#xD;
      suicide hotline, Veteran suicide completions have risen to 22 per day and suicide attempts&#xD;
      numbered over 15,000 in 2012. These data underscore the urgency of developing additional&#xD;
      interventions targeting suicidal Veterans. One potential avenue to further suicide treatment&#xD;
      and rehabilitation efforts is to develop strategies that maximize family support, however&#xD;
      almost no family interventions exist for suicidal Veterans. The construction of a Suicide&#xD;
      Safety Plan (SSP); a &quot;best practice,&quot; is mandated throughout the VA system, and a vital&#xD;
      component of the VA's coordinated effort at suicide prevention and recovery. The pilot data&#xD;
      on patterns of SSP use in suicidal Veterans highlighted the importance of sharing the plan&#xD;
      with family or close friends. However, respondents also noted significant obstacles in their&#xD;
      ability to reach out to others when in distress. To the knowledge of Investigators, there are&#xD;
      currently no recommended guidelines or mechanisms for involving family in safety planning,&#xD;
      despite its inclusion as a step of the plan. &quot;Safe Actions for Families to Encourage&#xD;
      Recovery&quot; (SAFER) a novel suicide safety planning family intervention has been designed to&#xD;
      fill this critical gap and provide a mechanism to communicate about safety planning. SAFER, a&#xD;
      4-session, family intervention, combines education about suicide and suicide safety planning&#xD;
      with communication skills training from evidence-based practices. The aim is to facilitate&#xD;
      communication about suicide safety planning and to develop both a Veteran and family member&#xD;
      safety plan.&#xD;
&#xD;
      Data from this project will test the intervention's feasibility, acceptability and&#xD;
      preliminary efficacy in a Stage II small-scale randomized clinical trial in 39 moderate&#xD;
      suicide risk Veterans and their supporting partners. The comparison condition will be safety&#xD;
      planning without supporting partner involvement plus weekly check-in phone calls. Primary&#xD;
      Veteran outcomes include reducing suicidal ideation/behavior. Secondary Veteran outcomes&#xD;
      include reducing suicidal cognitions (hopelessness, perceived burdensomeness, thwarted&#xD;
      belongingness) and depression and improving subjective social support. Supporting Partner&#xD;
      primary outcomes include reducing caregiver burden and secondary outcomes of improving&#xD;
      suicide-related coping and family empowerment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2017</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants are assigned to one of two groups in parallel for the duration of the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The individual who evaluates the outcomes of interest will not know the assigned condition of the participants.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Veteran Suicidal Ideation</measure>
    <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
    <description>Suicidality will be measured using the Columbia Suicide Severity Rating Scale. The C-SSRS was used across time points to record level of ideation, lifetime suicide attempts, and recent suicide attempts. The follow-up version of C-SSRS measured suicidal ideation and behavior that had occurred since the last assessment. The scale has inter-rater reliability of .97 and has been used extensively in prospective suicide studies. The scale has a minimum value of 0 and a maximum value of 5. Higher scores mean a worse outcome (more severe ideation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Supporting Partner Caregiver Burden</measure>
    <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
    <description>Caregiver burden will be evaluated by the Caregiver Burden Inventory (CBI), a 24-item scale assessing caregiver burden in four areas: physical, social, emotional and time dependence burden. Investigators found a large effect size in the pilot multifamily group study on this scale (Cohen's d = 1.03). Items were averaged to create an overall measure of caregiver burden and showed excellent internal consistency in this study (α =.94). CBI scores range from 0 (minimum) to 4 (maximum). Higher scores mean a worse outcome (greater caregiver burden).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Veterans With at Least 1 Suicide Attempt</measure>
    <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
    <description>These are the number of Veterans who reported at least one or more behaviors coded as &quot;actual suicide attempts&quot; since last visit using the Columbia Suicide Severity Rating Scale (C-SSRS). The follow-up version of C-SSRS measured suicidal ideation and behavior that had occurred since the last assessment. The scale has inter-rater reliability of .97 and has been used extensively in prospective suicide studies. A behavior was considered an &quot;actual suicide attempt&quot; if it was a potentially self-injurious act with any intent to die associated with it.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Veteran Suicide Related Coping</measure>
    <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
    <description>Suicide-related coping will be evaluated by the Stanley Suicide-related Coping Scale (SRCS), a 21-item self-report measure developed by Stanley, Green, Holloway, Brenner &amp; Brown to evaluate appraisal of one's ability to cope with suicidal ideation and urges, as well as ability to use the Safety Plan. Examples of items are: &quot;I am at the mercy of my suicidal thoughts&quot;, &quot;I have several things I can do to get through a suicidal crisis&quot;. Scores were averaged so that higher scores represent greater confidence and breadth of approaches to coping with suicidal thoughts and feelings (better outcome). SRCS scores have a minimum of 0 and a maximum of 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Veteran Thwarted Belongingness</measure>
    <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
    <description>Thwarted belongingness will be evaluated by Interpersonal Needs Questionnaire (INQ-15). The INQ is has demonstrated acceptable internal consistency for thwarted belongingness in this sample (TB) (α =.79). Scores on each subscale were averaged so that higher scores represent a greater degree of their respective constructs. Thwarted belongingness scores range from 1 (minimum) to 6 (maximum). Higher scores mean a worse outcome (decreased feelings of belongingness).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partner Support of Suicide-Related Coping</measure>
    <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
    <description>We have developed a family counterpart to the Stanley Suicide-related Coping Scale for Veterans that taps family members' appraisal of their ability to participate effectively in Veteran safety planning. Items include, &quot;I recognize the triggers and warning signs for suicidal ideation/urges for my Veteran&quot; and &quot;I know the numbers for the mobile crisis team to contact and nearest hospital or urgent care facility to accompany my Veteran to in a crisis.&quot; This measure will be validated against the more general Family Empowerment Scale. Items were rated on a 0 (Strongly Disagree) to 4 (Strongly Agree) scale and were averaged with higher scores indicating greater self-efficacy when supporting the Veteran through suicidal crises (better outcome). Partner SRCS scores range from 0 (minimum) to 4 (maximum).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Veteran Perceived Burdensomeness</measure>
    <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
    <description>Perceived burdensomeness will be evaluated by Interpersonal Needs Questionnaire (INQ-15). The INQ is has demonstrated excellent internal consistency for Perceived Burdensomeness (PB) (α= .95). Scores on each subscale were averaged so that higher scores represent a greater degree of their respective constructs. Perceived burdensomeness scores range from 1 (minimum) to 6 (maximum). Higher scores mean a worse outcome (greater perceived burdensomeness).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Veteran Hopelessness</measure>
    <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
    <description>Veteran hopelessness will be evaluated by the Beck Hopelessness Scale (BHS), a 20-item self-report measure with adequate reliability and validity which has been predictive of suicide in psychiatric inpatients. The BHS measures three aspects of hopelessness: feelings about the future, loss of motivation, and expectations. Items are true-false and are summed to get a total BHS score, ranging from 0 to 20. Higher scores reflect a worse outcome (greater hopelessness).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Veteran Depression</measure>
    <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
    <description>Veteran depression will be evaluated by the widely-used Beck Depression Inventory-II (BDI-II) (Cronbach's = .92). The BDI-II contains 21 items assessing depressive symptoms, each with minimum scores of 0 and maximum scores of 3. Item scores were summed, leading to a total score range of 0-63. Higher scores mean a worse outcome (more severe depressive symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver's Empowerment to Help Veteran</measure>
    <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
    <description>Caregiving self-efficacy/empowerment will be evaluated using the 12-item family subscale from the Family Empowerment Scale. This scale assesses the family's knowledge of mental health services and perceived ability to manage crises, and has demonstrated sensitivity to change in family intervention studies. Each item has a minimum score of 1 and a maximum score of 5, and were averaged to create a total score range of 1-5. Higher scores mean a better outcome (greater empowerment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Veteran's Report of Family Problem Solving</measure>
    <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
    <description>Veterans' reports of family problem solving will be evaluated by the 5-item Problem Solving subscale of the Family Assessment Device (FAD). Subscales have acceptable internal consistency (α = .72 to .83). Each item has a minimum score of 1 and a maximum score of 4, and were averaged to create a total score range of 1-4. Higher scores reflect worse outcomes (lower problem solving ability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Veteran's Report of Family Communication</measure>
    <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
    <description>Veterans' reports of family communication will be evaluated by the 6-item Communication subscale of the Family Assessment Device (FAD). Subscales have acceptable internal consistency (α = .72 to .83). Each item has a minimum score of 1 and a maximum score of 4, and were averaged to create a total score range of 1-4. Higher scores reflect worse outcomes (worse communication).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Suicide</condition>
  <arm_group>
    <arm_group_label>SAFER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAFER (Safe Actions for Families to Encourage Recovery): A novel, 5-session intervention to enhance currently mandated VA suicide safety planning by involving supporting partners to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and supporting partners with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or partner concerns with assurance that such requests will be listened to with validation and support, creating an ally for the suicidal Veteran in his struggle. As discussed above, research has demonstrated compellingly that suicidal desire is motivated by two interpersonal factors; perceived burdensomeness and thwarted belongingness. SAFER aims to increase partner support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>I-SPI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The comparison condition will be an assessment-only enhanced treatment-as-usual called the Individual Safety Planning Intervention (I-SPI), incorporating weekly scripted check-in phone calls to review mood symptoms and use of the safety plan, which will then be given as feedback to the Veteran's primary mental health provider.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Safe Actions for Families to Encourage Recovery</intervention_name>
    <description>A novel, 5-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns with assurance that such requests will be listened to with validation and support, creating an ally for the suicidal Veteran in his struggle. As discussed above, research has demonstrated compellingly that suicidal desire is motivated by two interpersonal factors; perceived burdensomeness and thwarted belongingness. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.</description>
    <arm_group_label>SAFER</arm_group_label>
    <other_name>SAFER</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individual Safety Planning Intervention</intervention_name>
    <description>The comparison condition will be an assessment-only enhanced treatment-as-usual intervention called the Individual Safety Planning Intervention (I-SPI).</description>
    <arm_group_label>I-SPI</arm_group_label>
    <other_name>I-SPI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria-Veterans:&#xD;
&#xD;
          -  Eligible Veterans must be identified as at moderate risk for suicide, defined as:&#xD;
&#xD;
               -  evidence of current (within the past week) suicidal ideation&#xD;
&#xD;
               -  plan or intent on the Columbia Suicide Severity Rating Scale (C-SSRS), but&#xD;
                  scoring less than or equal to 4 on the C-SSRS Behavior Scale, and without history&#xD;
                  of a lethal suicide attempt in the last 3 months.&#xD;
&#xD;
        Inclusion criteria also include the availability of a consenting, qualifying family member&#xD;
        or spouse/cohabiting partner.&#xD;
&#xD;
        Inclusion criteria-family member/significant others:&#xD;
&#xD;
          -  Family members/friends must meet at least three (two for nonrelatives) of five&#xD;
             criteria:&#xD;
&#xD;
               -  is a spouse, co-habiting significant other or parent&#xD;
&#xD;
               -  has more frequent contact than any other caregiver&#xD;
&#xD;
               -  helps to support the patient financially&#xD;
&#xD;
               -  is contacted by treatment staff for emergencies&#xD;
&#xD;
               -  has been involved in the patient's treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria for Veterans and family/partners are:&#xD;
&#xD;
          -  untreated or un-medicated psychosis&#xD;
&#xD;
          -  current alcohol or drug abuse or dependence defined by a Patient Health Questionnaire&#xD;
             (PHQ) for Alcohol &amp; Drug Use&#xD;
&#xD;
          -  for couples, &quot;severe&quot; intimate-partner violence as defined by the revised 20-item&#xD;
             Conflict Tactics Scale Short Form (CTS2S)&#xD;
&#xD;
          -  medical condition or life event, e.g.,&#xD;
&#xD;
          -  participation in another family-based psychosocial intervention trial six months prior&#xD;
             to study&#xD;
&#xD;
          -  limited English proficiency. Participants will be screened for inclusion/exclusion as&#xD;
             described above immediately after giving consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marianne S. Goodman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>James J. Peters Veterans Affairs Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>James J. Peters VA Medical Center, Bronx, NY</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10468</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <results_first_submitted>August 13, 2021</results_first_submitted>
  <results_first_submitted_qc>November 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 10, 2021</results_first_posted>
  <last_update_submitted>November 22, 2021</last_update_submitted>
  <last_update_submitted_qc>November 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Family Caregivers</keyword>
  <keyword>Spouse Caregivers</keyword>
  <keyword>Veterans</keyword>
  <keyword>Suicide</keyword>
  <keyword>Clinical Trial</keyword>
  <keyword>Military Families</keyword>
  <keyword>Military Psychology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT03034863/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study recruited, consented, and randomized 39 Veterans at risk for suicide and 39 corresponding supporting partners over a 30-month period from a large VA medical center in a major metropolitan area in the North East. Recruitment sources included VA suicide prevention coordinators, a Veteran's primary clinician from the VA Medical Center's (VAMC) psychiatric inpatient unit or outpatient care center, or through community outreach (e.g., Vet Centers and higher education institutions).</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>SAFER</title>
          <description>Safe Actions for Families to Encourage Recovery (SAFER): A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.&#xD;
Safe Actions for Families to Encourage Recovery: A novel, 4-session intervention to enhance VA suicide safety planning by involving family members to support its implementation.</description>
        </group>
        <group group_id="P2">
          <title>I-SPI</title>
          <description>The comparison condition will be an assessment-only enhanced treatment-as-usual, the currently mandated Individual Safety Planning Intervention (I-SPI). I-SPI incorporates update and use of the safety plan, which will then be uploaded to the Computerized Patient Record System (CPRS) so the Veterans' primary mental health providers can access.&#xD;
Treatment-as-Usual: The comparison condition will be an assessment-only enhanced treatment-as-usual called the Individual Safety Planning Intervention (I-SPI).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Veterans</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Supporting Partners</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The overall sample included 39 veterans with recent suicidal ideation and/or a history of a suicide attempt. The 39 dyads also included a variety of relationships including 14 romantic partners, 13 non-romantic family members (e.g., adult children of veterans, veterans' parents), and 12 close friends.</population>
      <group_list>
        <group group_id="B1">
          <title>SAFER</title>
          <description>SAFER: A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns with assurance that such requests will be listened to with validation and support, creating an ally for the suicidal Veteran in his struggle. As discussed above, research has demonstrated compellingly that suicidal desire is motivated by two interpersonal factors; perceived burdensomeness and thwarted belongingness. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.&#xD;
Safe Actions for Families to Encourage Recovery: A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation.</description>
        </group>
        <group group_id="B2">
          <title>I-SPI</title>
          <description>The comparison condition will be an assessment-only enhanced treatment-as-usual (E-TAU), the currently mandated Individual Safety Planning Intervention (I-SPI). I-SPI incorporates weekly scripted check-in phone calls to review mood symptoms and use of the safety plan, which will then be given as feedback to the Veteran's primary mental health provider.&#xD;
Treatment-as-Usual: The comparison condition will be an assessment-only enhanced treatment-as-usual called the Individual Safety Planning Intervention (I-SPI).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="38"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="78"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>This baseline measure specifically looks at Veterans.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran age whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <description>This baseline measure specifically looks at caregivers.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at caregiver age whereas overall number includes both caregiver and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <description>This baseline measure specifically looks at Veterans.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran age whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.26" spread="12.37"/>
                    <measurement group_id="B2" value="51.90" spread="15.62"/>
                    <measurement group_id="B3" value="52.58" spread="14.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <description>This baseline measure specifically looks at caregivers.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at caregiver age whereas overall number includes both caregiver and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.68" spread="16.24"/>
                    <measurement group_id="B2" value="42.55" spread="12.80"/>
                    <measurement group_id="B3" value="45.62" spread="14.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>This baseline measure specifically looks at Veterans.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran sex whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>This baseline measure specifically looks at caregivers.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at caregiver sex whereas overall number includes both caregiver and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <description>This baseline measure specifically looks at Veterans.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran ethnicity whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <description>This baseline measure specifically looks at caregivers.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at caregiver ethnicity whereas overall number includes both caregiver and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>This baseline measure specifically looks at Veterans.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran race whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>This baseline measure specifically looks at caregivers.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at caregiver race whereas overall number includes both caregiver and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>This baseline measure specifically looks at Veterans.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran region of enrollment whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>This baseline measure specifically looks at caregivers.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at caregiver region of enrollment whereas overall number includes both caregiver and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Veteran Suicidal Ideation</title>
          <description>Moderate suicidality was measured to determine eligibility using the Columbia Suicide Severity Rating Scale (C-SSRS). The psychometric properties of the C-SSRS across multiple studies suggest moderate to strong validity and internal consistency of the ideation intensity subscale (Cronbach's alpha 0.73-0.946; Posner et al., 2011). The baseline C-SSRS measured recent (past 3 months) and lifetime severity of suicidal ideation. Baseline ideation scores were based on recent ideation. Scores range from 0 to 5. High scores mean a worse outcome (more severe ideation).</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran suicidal ideation whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.26" spread="1.69"/>
                    <measurement group_id="B2" value="3.75" spread="1.33"/>
                    <measurement group_id="B3" value="3.51" spread="1.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Veteran Suicide-Related Coping</title>
          <description>Suicide-related coping was evaluated by the Suicide-related Coping Scale (SRCS), a 17-item self-report measure assessing one's ability to cope with suicidal ideation and urges (Stanley, Green, Ghahramanlou-Holloway, Brenner, &amp; Brown, 2017). The scale demonstrated good internal consistency (α=.85) at baseline; scores were averaged so that higher scores represent greater confidence and breadth of approaches to coping with suicidal thoughts and feelings (better outcome). SRCS scores have a minimum of 0 and a maximum of 4.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran suicide-related coping whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.03" spread="0.71"/>
                    <measurement group_id="B2" value="2.91" spread="0.65"/>
                    <measurement group_id="B3" value="2.97" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Partner Support of Suicide-Related Coping</title>
          <description>Supporting partners also completed five items adapted from the SRCS that assessed their confidence in their ability to support the Veteran through their suicidal urges. Items were rated on a 0 (Strongly Disagree) to 4 (Strongly Agree) scale and were averaged with higher scores indicating greater self-efficacy when supporting the Veteran through suicidal crises (better outcome). In addition to face validity, the scale showed acceptable internal consistency in the sample (α=.78). Partner SRCS scores range from 0 (minimum) to 4 (maximum).</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Partner support of suicide-related coping whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.23" spread="0.81"/>
                    <measurement group_id="B2" value="3.37" spread="0.87"/>
                    <measurement group_id="B3" value="3.3" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Veteran Thwarted Belongingness</title>
          <description>Thwarted belongingness was evaluated by the Interpersonal Needs Questionnaire (INQ-15; Van Orden, Cukrowicz, Witte, &amp; Joiner, 2012). Scores on each subscale were averaged so that higher scores represent a greater degree of their respective constructs. Thwarted Belongingness showed acceptable internal consistency in this sample (α =.79). Thwarted belongingness scores range from 1 (minimum) to 6 (maximum). Higher scores mean a worse outcome (decreased feelings of belongingness).</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran thwarted belongingness whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.23" spread="1.02"/>
                    <measurement group_id="B2" value="3.62" spread="0.9"/>
                    <measurement group_id="B3" value="3.43" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Veteran Perceived Burdensomeness</title>
          <description>Perceived burdensomeness was evaluated by the Interpersonal Needs Questionnaire (INQ-15; Van Orden, Cukrowicz, Witte, &amp; Joiner, 2012). Scores on each subscale were averaged so that higher scores represent a greater degree of their respective constructs. Perceived Burdensomeness demonstrated excellent internal consistency in this sample (α= .95). Perceived burdensomeness scores range from 1 (minimum) to 6 (maximum). Higher scores mean a worse outcome (greater perceived burdensomeness).</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran perceived burdensomeness whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.84" spread="1.56"/>
                    <measurement group_id="B2" value="3.03" spread="1.61"/>
                    <measurement group_id="B3" value="2.94" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Supporting Partner Caregiver Burden</title>
          <description>Caregiver burden was evaluated using the Caregiver Burden Inventory (CBI; Novak &amp; Guest, 1989), a 24-item scale assessing caregiver burden in five areas: time, physical, social, developmental, and emotional burden. Items were averaged to create an overall measure of caregiver burden and showed excellent internal consistency in this study (α =.94). CBI scores range from 0 (minimum) to 4 (maximum). Higher scores mean a worse outcome (greater caregiver burden).</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Partner caregiver burden whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.39" spread="0.92"/>
                    <measurement group_id="B2" value="1.06" spread="0.96"/>
                    <measurement group_id="B3" value="1.23" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Veteran Hopelessness</title>
          <description>Veteran hopelessness will be evaluated by the Beck Hopelessness Scale (BHS), a 20-item self-report measure with adequate reliability and validity which has been predictive of suicide in psychiatric inpatients. The BHS measures three aspects of hopelessness: feelings about the future, loss of motivation, and expectations. Items are true-false and are summed to get a total BHS score, ranging from 0 to 20. Higher scores reflect a worse outcome (greater hopelessness).</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran hopelessness whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.95" spread="5.79"/>
                    <measurement group_id="B2" value="11.72" spread="6.57"/>
                    <measurement group_id="B3" value="9.34" spread="6.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Veteran Depression</title>
          <description>Veteran depression will be evaluated by the widely-used Beck Depression Inventory-II (BDI-II) (Cronbach's = .92). The BDI-II contains 21 items assessing depressive symptoms, each with minimum scores of 0 and maximum scores of 3. Item scores were summed, leading to a total score range of 0-63. Higher scores mean a worse outcome (more severe depressive symptoms).</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran depression whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.36" spread="11.75"/>
                    <measurement group_id="B2" value="32.5" spread="15.56"/>
                    <measurement group_id="B3" value="28.43" spread="13.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Caregiver's Empowerment to Help Veteran</title>
          <description>Caregiving self-efficacy/empowerment will be evaluated using the 12-item family subscale from the Family Empowerment Scale. This scale assesses the family's knowledge of mental health services and perceived ability to manage crises, and has demonstrated sensitivity to change in family intervention studies. Each item has a minimum score of 1 and a maximum score of 5, and were averaged to create a total score range of 1-5. Higher scores mean a better outcome (greater empowerment).</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Partner caregiver empowerment whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.79" spread="0.64"/>
                    <measurement group_id="B2" value="3.75" spread="0.80"/>
                    <measurement group_id="B3" value="3.77" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Veteran's Report of Family Problem Solving</title>
          <description>Veterans' reports of family problem solving will be evaluated by the 5-item Problem Solving subscale of the Family Assessment Device (FAD). Subscales have acceptable internal consistency (α = .72 to .83). Each item has a minimum score of 1 and a maximum score of 4, and were averaged to create a total score range of 1-4. Higher scores reflect worse outcomes (lower problem solving ability).</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran reports of family problem solving whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.27" spread="0.62"/>
                    <measurement group_id="B2" value="2.44" spread="0.74"/>
                    <measurement group_id="B3" value="2.36" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Veteran's Reports of Family Communication</title>
          <description>Veterans' reports of family communication will be evaluated by the 6-item Communication subscale of the Family Assessment Device (FAD). Subscales have acceptable internal consistency (α = .72 to .83). Each item has a minimum score of 1 and a maximum score of 4, and were averaged to create a total score range of 1-4. Higher scores reflect worse outcomes (worse communication).</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran reports of family communication whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.42" spread="0.37"/>
                    <measurement group_id="B2" value="2.53" spread="0.41"/>
                    <measurement group_id="B3" value="2.48" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Veterans with at least 1 Suicide Attempt</title>
          <description>These are the number of Veterans who reported at least one or more behaviors in their lifetime that were coded as &quot;actual suicide attempt&quot; using the C-SSRS criteria. A behavior was considered an &quot;actual suicide attempt&quot; if it was a potentially self-injurious act with any intent to die associated with it. The baseline C-SSRS measured instances of suicidal behavior in the past year, as well as during the participant's lifetime.</description>
          <population>Number analyzed in row differs from overall because this specifically looked at Veteran suicide attempts whereas overall number includes both Veteran and their dyad partner. Therefore the number analyzed is half the total of each condition.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Veteran Suicidal Ideation</title>
        <description>Suicidality will be measured using the Columbia Suicide Severity Rating Scale. The C-SSRS was used across time points to record level of ideation, lifetime suicide attempts, and recent suicide attempts. The follow-up version of C-SSRS measured suicidal ideation and behavior that had occurred since the last assessment. The scale has inter-rater reliability of .97 and has been used extensively in prospective suicide studies. The scale has a minimum value of 0 and a maximum value of 5. Higher scores mean a worse outcome (more severe ideation).</description>
        <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
        <population>Some participants lost between baseline and post-treatment follow-up and extended 3 month follow up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Veterans in SAFER</title>
            <description>Veteran participants in the SAFER (intervention) condition</description>
          </group>
          <group group_id="O2">
            <title>Veterans in I-SPI</title>
            <description>Veterans in the I-SPI (control) condition</description>
          </group>
        </group_list>
        <measure>
          <title>Veteran Suicidal Ideation</title>
          <description>Suicidality will be measured using the Columbia Suicide Severity Rating Scale. The C-SSRS was used across time points to record level of ideation, lifetime suicide attempts, and recent suicide attempts. The follow-up version of C-SSRS measured suicidal ideation and behavior that had occurred since the last assessment. The scale has inter-rater reliability of .97 and has been used extensively in prospective suicide studies. The scale has a minimum value of 0 and a maximum value of 5. Higher scores mean a worse outcome (more severe ideation).</description>
          <population>Some participants lost between baseline and post-treatment follow-up and extended 3 month follow up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" spread="1.93"/>
                    <measurement group_id="O2" value="3.50" spread="1.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="1.31"/>
                    <measurement group_id="O2" value="3.38" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.03</p_value>
            <p_value_desc>All p-values are two-tailed</p_value_desc>
            <method>Hierarchical Linear Modeling/MLM</method>
            <method_desc>Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.</method_desc>
            <param_type>Slope</param_type>
            <param_value>-0.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Supporting Partner Caregiver Burden</title>
        <description>Caregiver burden will be evaluated by the Caregiver Burden Inventory (CBI), a 24-item scale assessing caregiver burden in four areas: physical, social, emotional and time dependence burden. Investigators found a large effect size in the pilot multifamily group study on this scale (Cohen's d = 1.03). Items were averaged to create an overall measure of caregiver burden and showed excellent internal consistency in this study (α =.94). CBI scores range from 0 (minimum) to 4 (maximum). Higher scores mean a worse outcome (greater caregiver burden).</description>
        <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
        <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to supporting partners (does not include Veterans) and therefore include about half of the total participants in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Caregivers in SAFER</title>
            <description>Caregivers in the SAFER (intervention) condition</description>
          </group>
          <group group_id="O2">
            <title>Caregivers in I-SPI</title>
            <description>Caregivers in the I-SPI (control) condition</description>
          </group>
        </group_list>
        <measure>
          <title>Supporting Partner Caregiver Burden</title>
          <description>Caregiver burden will be evaluated by the Caregiver Burden Inventory (CBI), a 24-item scale assessing caregiver burden in four areas: physical, social, emotional and time dependence burden. Investigators found a large effect size in the pilot multifamily group study on this scale (Cohen's d = 1.03). Items were averaged to create an overall measure of caregiver burden and showed excellent internal consistency in this study (α =.94). CBI scores range from 0 (minimum) to 4 (maximum). Higher scores mean a worse outcome (greater caregiver burden).</description>
          <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to supporting partners (does not include Veterans) and therefore include about half of the total participants in the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.23" spread="0.85"/>
                    <measurement group_id="O2" value="1.00" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.90" spread="0.59"/>
                    <measurement group_id="O2" value="0.72" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.69</p_value>
            <method>Hierarchical Linear Modeling/MLM</method>
            <method_desc>Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.</method_desc>
            <param_type>Slope</param_type>
            <param_value>-0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.05</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Veterans With at Least 1 Suicide Attempt</title>
        <description>These are the number of Veterans who reported at least one or more behaviors coded as &quot;actual suicide attempts&quot; since last visit using the Columbia Suicide Severity Rating Scale (C-SSRS). The follow-up version of C-SSRS measured suicidal ideation and behavior that had occurred since the last assessment. The scale has inter-rater reliability of .97 and has been used extensively in prospective suicide studies. A behavior was considered an &quot;actual suicide attempt&quot; if it was a potentially self-injurious act with any intent to die associated with it.</description>
        <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
        <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Veterans in SAFER</title>
            <description>Veteran participants in the SAFER (intervention) condition</description>
          </group>
          <group group_id="O2">
            <title>Veterans in I-SPI</title>
            <description>Veterans in the I-SPI (control) condition</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Veterans With at Least 1 Suicide Attempt</title>
          <description>These are the number of Veterans who reported at least one or more behaviors coded as &quot;actual suicide attempts&quot; since last visit using the Columbia Suicide Severity Rating Scale (C-SSRS). The follow-up version of C-SSRS measured suicidal ideation and behavior that had occurred since the last assessment. The scale has inter-rater reliability of .97 and has been used extensively in prospective suicide studies. A behavior was considered an &quot;actual suicide attempt&quot; if it was a potentially self-injurious act with any intent to die associated with it.</description>
          <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.49</p_value>
            <p_value_desc>All p-values are two-tailed</p_value_desc>
            <method>Fisher Exact</method>
            <method_desc>Compares veterans who reported 1+ attempts at any follow-up wave out of total number of veterans in each group (i.e., 0/19 for SAFER; 2/20 for I-SPI).</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Veteran Suicide Related Coping</title>
        <description>Suicide-related coping will be evaluated by the Stanley Suicide-related Coping Scale (SRCS), a 21-item self-report measure developed by Stanley, Green, Holloway, Brenner &amp; Brown to evaluate appraisal of one's ability to cope with suicidal ideation and urges, as well as ability to use the Safety Plan. Examples of items are: &quot;I am at the mercy of my suicidal thoughts&quot;, &quot;I have several things I can do to get through a suicidal crisis&quot;. Scores were averaged so that higher scores represent greater confidence and breadth of approaches to coping with suicidal thoughts and feelings (better outcome). SRCS scores have a minimum of 0 and a maximum of 4.</description>
        <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
        <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Veterans in SAFER</title>
            <description>Veteran participants in the SAFER (intervention) condition</description>
          </group>
          <group group_id="O2">
            <title>Veterans in I-SPI</title>
            <description>Veterans in the I-SPI (control) condition</description>
          </group>
        </group_list>
        <measure>
          <title>Veteran Suicide Related Coping</title>
          <description>Suicide-related coping will be evaluated by the Stanley Suicide-related Coping Scale (SRCS), a 21-item self-report measure developed by Stanley, Green, Holloway, Brenner &amp; Brown to evaluate appraisal of one's ability to cope with suicidal ideation and urges, as well as ability to use the Safety Plan. Examples of items are: &quot;I am at the mercy of my suicidal thoughts&quot;, &quot;I have several things I can do to get through a suicidal crisis&quot;. Scores were averaged so that higher scores represent greater confidence and breadth of approaches to coping with suicidal thoughts and feelings (better outcome). SRCS scores have a minimum of 0 and a maximum of 4.</description>
          <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.15" spread="0.71"/>
                    <measurement group_id="O2" value="2.69" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.12" spread="0.59"/>
                    <measurement group_id="O2" value="2.70" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.03</p_value>
            <method>Hierarchical Linear Modeling/MLM</method>
            <method_desc>Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.</method_desc>
            <param_type>Slope</param_type>
            <param_value>0.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Veteran Thwarted Belongingness</title>
        <description>Thwarted belongingness will be evaluated by Interpersonal Needs Questionnaire (INQ-15). The INQ is has demonstrated acceptable internal consistency for thwarted belongingness in this sample (TB) (α =.79). Scores on each subscale were averaged so that higher scores represent a greater degree of their respective constructs. Thwarted belongingness scores range from 1 (minimum) to 6 (maximum). Higher scores mean a worse outcome (decreased feelings of belongingness).</description>
        <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
        <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Veterans in SAFER</title>
            <description>Veteran participants in the SAFER (treatment) condition</description>
          </group>
          <group group_id="O2">
            <title>Veterans in I-SPI</title>
            <description>Veterans in the I-SPI (control) condition</description>
          </group>
        </group_list>
        <measure>
          <title>Veteran Thwarted Belongingness</title>
          <description>Thwarted belongingness will be evaluated by Interpersonal Needs Questionnaire (INQ-15). The INQ is has demonstrated acceptable internal consistency for thwarted belongingness in this sample (TB) (α =.79). Scores on each subscale were averaged so that higher scores represent a greater degree of their respective constructs. Thwarted belongingness scores range from 1 (minimum) to 6 (maximum). Higher scores mean a worse outcome (decreased feelings of belongingness).</description>
          <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.85" spread="1.27"/>
                    <measurement group_id="O2" value="3.57" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.30" spread="1.46"/>
                    <measurement group_id="O2" value="3.45" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.87</p_value>
            <method>Hierarchical Linear Modeling/MLM</method>
            <method_desc>Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.</method_desc>
            <param_type>Slope</param_type>
            <param_value>0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.07</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Partner Support of Suicide-Related Coping</title>
        <description>We have developed a family counterpart to the Stanley Suicide-related Coping Scale for Veterans that taps family members' appraisal of their ability to participate effectively in Veteran safety planning. Items include, &quot;I recognize the triggers and warning signs for suicidal ideation/urges for my Veteran&quot; and &quot;I know the numbers for the mobile crisis team to contact and nearest hospital or urgent care facility to accompany my Veteran to in a crisis.&quot; This measure will be validated against the more general Family Empowerment Scale. Items were rated on a 0 (Strongly Disagree) to 4 (Strongly Agree) scale and were averaged with higher scores indicating greater self-efficacy when supporting the Veteran through suicidal crises (better outcome). Partner SRCS scores range from 0 (minimum) to 4 (maximum).</description>
        <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
        <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to supporting partners (does not include Veterans) and therefore include about half of the total participants in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Caregivers in SAFER</title>
            <description>Caregivers in the SAFER (intervention) condition</description>
          </group>
          <group group_id="O2">
            <title>Caregivers in I-SPI</title>
            <description>Caregivers in the I-SPI (control) condition</description>
          </group>
        </group_list>
        <measure>
          <title>Partner Support of Suicide-Related Coping</title>
          <description>We have developed a family counterpart to the Stanley Suicide-related Coping Scale for Veterans that taps family members' appraisal of their ability to participate effectively in Veteran safety planning. Items include, &quot;I recognize the triggers and warning signs for suicidal ideation/urges for my Veteran&quot; and &quot;I know the numbers for the mobile crisis team to contact and nearest hospital or urgent care facility to accompany my Veteran to in a crisis.&quot; This measure will be validated against the more general Family Empowerment Scale. Items were rated on a 0 (Strongly Disagree) to 4 (Strongly Agree) scale and were averaged with higher scores indicating greater self-efficacy when supporting the Veteran through suicidal crises (better outcome). Partner SRCS scores range from 0 (minimum) to 4 (maximum).</description>
          <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to supporting partners (does not include Veterans) and therefore include about half of the total participants in the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.65" spread="0.46"/>
                    <measurement group_id="O2" value="3.36" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.70" spread="0.57"/>
                    <measurement group_id="O2" value="2.89" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.03</p_value>
            <method>Hierarchical Linear Modeling/MLM</method>
            <method_desc>Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.</method_desc>
            <param_type>Slope</param_type>
            <param_value>0.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.08</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Veteran Perceived Burdensomeness</title>
        <description>Perceived burdensomeness will be evaluated by Interpersonal Needs Questionnaire (INQ-15). The INQ is has demonstrated excellent internal consistency for Perceived Burdensomeness (PB) (α= .95). Scores on each subscale were averaged so that higher scores represent a greater degree of their respective constructs. Perceived burdensomeness scores range from 1 (minimum) to 6 (maximum). Higher scores mean a worse outcome (greater perceived burdensomeness).</description>
        <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
        <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Veterans in SAFER</title>
            <description>Veteran participants in the SAFER (intervention) condition</description>
          </group>
          <group group_id="O2">
            <title>Veterans in I-SPI</title>
            <description>Veterans in the I-SPI (control) condition</description>
          </group>
        </group_list>
        <measure>
          <title>Veteran Perceived Burdensomeness</title>
          <description>Perceived burdensomeness will be evaluated by Interpersonal Needs Questionnaire (INQ-15). The INQ is has demonstrated excellent internal consistency for Perceived Burdensomeness (PB) (α= .95). Scores on each subscale were averaged so that higher scores represent a greater degree of their respective constructs. Perceived burdensomeness scores range from 1 (minimum) to 6 (maximum). Higher scores mean a worse outcome (greater perceived burdensomeness).</description>
          <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.23" spread="1.39"/>
                    <measurement group_id="O2" value="2.60" spread="1.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.10" spread="1.63"/>
                    <measurement group_id="O2" value="2.86" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.16</p_value>
            <method>Hierarchical Linear Modeling/MLM</method>
            <method_desc>Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.</method_desc>
            <param_type>Slope</param_type>
            <param_value>-0.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.08</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Veteran Hopelessness</title>
        <description>Veteran hopelessness will be evaluated by the Beck Hopelessness Scale (BHS), a 20-item self-report measure with adequate reliability and validity which has been predictive of suicide in psychiatric inpatients. The BHS measures three aspects of hopelessness: feelings about the future, loss of motivation, and expectations. Items are true-false and are summed to get a total BHS score, ranging from 0 to 20. Higher scores reflect a worse outcome (greater hopelessness).</description>
        <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
        <population>Some participants lost between baseline and post-treatment follow-up and extended 3 month follow up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Veterans in SAFER</title>
            <description>Veteran participants in the SAFER (intervention) condition</description>
          </group>
          <group group_id="O2">
            <title>Veterans in I-SPI</title>
            <description>Veterans in the I-SPI (control) condition</description>
          </group>
        </group_list>
        <measure>
          <title>Veteran Hopelessness</title>
          <description>Veteran hopelessness will be evaluated by the Beck Hopelessness Scale (BHS), a 20-item self-report measure with adequate reliability and validity which has been predictive of suicide in psychiatric inpatients. The BHS measures three aspects of hopelessness: feelings about the future, loss of motivation, and expectations. Items are true-false and are summed to get a total BHS score, ranging from 0 to 20. Higher scores reflect a worse outcome (greater hopelessness).</description>
          <population>Some participants lost between baseline and post-treatment follow-up and extended 3 month follow up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.40" spread="6.49"/>
                    <measurement group_id="O2" value="11.73" spread="7.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.09" spread="7.84"/>
                    <measurement group_id="O2" value="12.61" spread="6.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.81</p_value>
            <p_value_desc>All p-values are two-tailed</p_value_desc>
            <method>Hierarchical Linear Modeling/MLM</method>
            <method_desc>Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.</method_desc>
            <param_type>Slope</param_type>
            <param_value>.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.35</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Veteran Depression</title>
        <description>Veteran depression will be evaluated by the widely-used Beck Depression Inventory-II (BDI-II) (Cronbach's = .92). The BDI-II contains 21 items assessing depressive symptoms, each with minimum scores of 0 and maximum scores of 3. Item scores were summed, leading to a total score range of 0-63. Higher scores mean a worse outcome (more severe depressive symptoms).</description>
        <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
        <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Veterans in SAFER</title>
            <description>Veteran participants in the SAFER (intervention) condition</description>
          </group>
          <group group_id="O2">
            <title>Veterans in I-SPI</title>
            <description>Veterans in the I-SPI (control) condition</description>
          </group>
        </group_list>
        <measure>
          <title>Veteran Depression</title>
          <description>Veteran depression will be evaluated by the widely-used Beck Depression Inventory-II (BDI-II) (Cronbach's = .92). The BDI-II contains 21 items assessing depressive symptoms, each with minimum scores of 0 and maximum scores of 3. Item scores were summed, leading to a total score range of 0-63. Higher scores mean a worse outcome (more severe depressive symptoms).</description>
          <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.20" spread="16.92"/>
                    <measurement group_id="O2" value="29.07" spread="18.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.33" spread="16.20"/>
                    <measurement group_id="O2" value="31.08" spread="17.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.55</p_value>
            <p_value_desc>All p-values are two-tailed</p_value_desc>
            <method>Hierarchical Linear Modeling/MLM</method>
            <method_desc>Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.</method_desc>
            <param_type>Slope</param_type>
            <param_value>-.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.62</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Caregiver's Empowerment to Help Veteran</title>
        <description>Caregiving self-efficacy/empowerment will be evaluated using the 12-item family subscale from the Family Empowerment Scale. This scale assesses the family's knowledge of mental health services and perceived ability to manage crises, and has demonstrated sensitivity to change in family intervention studies. Each item has a minimum score of 1 and a maximum score of 5, and were averaged to create a total score range of 1-5. Higher scores mean a better outcome (greater empowerment).</description>
        <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
        <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to supporting partners (does not include Veterans) and therefore include about half of the total participants in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Caregivers in SAFER</title>
            <description>Caregivers in the SAFER (intervention) condition</description>
          </group>
          <group group_id="O2">
            <title>Caregivers in I-SPI</title>
            <description>Caregivers in the I-SPI (control) condition</description>
          </group>
        </group_list>
        <measure>
          <title>Caregiver's Empowerment to Help Veteran</title>
          <description>Caregiving self-efficacy/empowerment will be evaluated using the 12-item family subscale from the Family Empowerment Scale. This scale assesses the family's knowledge of mental health services and perceived ability to manage crises, and has demonstrated sensitivity to change in family intervention studies. Each item has a minimum score of 1 and a maximum score of 5, and were averaged to create a total score range of 1-5. Higher scores mean a better outcome (greater empowerment).</description>
          <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to supporting partners (does not include Veterans) and therefore include about half of the total participants in the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.71" spread="0.78"/>
                    <measurement group_id="O2" value="3.91" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.91" spread="0.67"/>
                    <measurement group_id="O2" value="3.87" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.64</p_value>
            <p_value_desc>All p-values are two-tailed</p_value_desc>
            <method>Hierarchical Linear Modeling/MLM</method>
            <method_desc>Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.</method_desc>
            <param_type>Slope</param_type>
            <param_value>.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.05</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Veteran's Report of Family Problem Solving</title>
        <description>Veterans' reports of family problem solving will be evaluated by the 5-item Problem Solving subscale of the Family Assessment Device (FAD). Subscales have acceptable internal consistency (α = .72 to .83). Each item has a minimum score of 1 and a maximum score of 4, and were averaged to create a total score range of 1-4. Higher scores reflect worse outcomes (lower problem solving ability).</description>
        <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
        <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Veterans in SAFER</title>
            <description>Veteran participants in the SAFER (intervention) condition</description>
          </group>
          <group group_id="O2">
            <title>Veterans in I-SPI</title>
            <description>Veterans in the I-SPI (control) condition</description>
          </group>
        </group_list>
        <measure>
          <title>Veteran's Report of Family Problem Solving</title>
          <description>Veterans' reports of family problem solving will be evaluated by the 5-item Problem Solving subscale of the Family Assessment Device (FAD). Subscales have acceptable internal consistency (α = .72 to .83). Each item has a minimum score of 1 and a maximum score of 4, and were averaged to create a total score range of 1-4. Higher scores reflect worse outcomes (lower problem solving ability).</description>
          <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.33" spread="0.86"/>
                    <measurement group_id="O2" value="2.23" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.36" spread="0.64"/>
                    <measurement group_id="O2" value="2.40" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.62</p_value>
            <p_value_desc>All p-values are two-tailed</p_value_desc>
            <method>Hierarchical Linear Modeling/MLM</method>
            <method_desc>Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.</method_desc>
            <param_type>Slope</param_type>
            <param_value>-.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.04</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Veteran's Report of Family Communication</title>
        <description>Veterans' reports of family communication will be evaluated by the 6-item Communication subscale of the Family Assessment Device (FAD). Subscales have acceptable internal consistency (α = .72 to .83). Each item has a minimum score of 1 and a maximum score of 4, and were averaged to create a total score range of 1-4. Higher scores reflect worse outcomes (worse communication).</description>
        <time_frame>POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)</time_frame>
        <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Veterans in SAFER</title>
            <description>Veteran participants in the SAFER (intervention) condition</description>
          </group>
          <group group_id="O2">
            <title>Veterans in I-SPI</title>
            <description>Veterans in the I-SPI (control) condition</description>
          </group>
        </group_list>
        <measure>
          <title>Veteran's Report of Family Communication</title>
          <description>Veterans' reports of family communication will be evaluated by the 6-item Communication subscale of the Family Assessment Device (FAD). Subscales have acceptable internal consistency (α = .72 to .83). Each item has a minimum score of 1 and a maximum score of 4, and were averaged to create a total score range of 1-4. Higher scores reflect worse outcomes (worse communication).</description>
          <population>Some participants lost between baseline and post-treatment follow-up and extended 3-month follow-up. These groups specifically refer to Veterans (does not include supporting partners) and therefore include about half of the total participants in the study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.34" spread="0.39"/>
                    <measurement group_id="O2" value="2.33" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended Follow-Up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.33" spread="0.28"/>
                    <measurement group_id="O2" value="2.27" spread="0.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.16</p_value>
            <p_value_desc>All p-values are two-tailed</p_value_desc>
            <method>Hierarchical Linear Modeling/MLM</method>
            <method_desc>Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.</method_desc>
            <param_type>Slope</param_type>
            <param_value>.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.03</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year, 8 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SAFER: Veterans</title>
          <description>SAFER: A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.&#xD;
Safe Actions for Families to Encourage Recovery: A novel, 4-session intervention to enhance VA suicide safety planning by involving family members to support its implementation.</description>
        </group>
        <group group_id="E2">
          <title>I-SPI: Veterans</title>
          <description>The comparison condition will be an assessment-only enhanced treatment-as-usual (E-TAU), incorporating update and use of the safety plan, which will then be uploaded to CPRS so the Veterans' primary mental health providers can access.&#xD;
Treatment-as-Usual: The comparison condition will be an assessment-only enhanced treatment-as-usual (TAU).</description>
        </group>
        <group group_id="E3">
          <title>SAFER: Caregivers</title>
          <description>SAFER: A novel, 4-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.</description>
        </group>
        <group group_id="E4">
          <title>I-SPI: Caregivers</title>
          <description>The comparison condition will be an assessment-only enhanced treatment-as-usual (E-TAU), incorporating update and use of the safety plan, which will then be uploaded to CPRS so the Veterans' primary mental health providers can access.&#xD;
Treatment-as-Usual: The comparison condition will be an assessment-only enhanced treatment-as-usual (TAU).</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric Hospitalization</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Knee Operation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>ER for Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ER for Urination Issue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The proposed evaluation of SAFER has limitations. First, our strategy only targeted moderate risk suicidal Veterans. Second, there was a relatively small sample size of 39 suicidal Veterans and 39 supporting partners. Third, conducting the study in a high density, urban setting may result in different findings than if conducted in a rural setting. Fourth, the study arms were not matched for treatment dosage (SAFER: 4 sessions versus I-SPI: single session).</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Marianne Goodman, MD</name_or_title>
      <organization>James J Peters VAMC</organization>
      <phone>718-584-9000 ext 5188</phone>
      <email>Marianne.Goodman@va.gov</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03034863
org study id: D2432-R
secondary id: RX002432-01
nct id: NCT03034863
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The management of suicide risk is a pressing national public health issue especially among
      Veterans, and there exist no guidelines of how best to involve family members in this effort.
      This proposal will integrate family and couples communication skills training with suicide
      safety planning. The goal is for the sharing of Veteran suicide safety plans with family
      members and the construction of a parallel family member safety plan, in efforts to mobilize
      and support family involvement.
Psychological models of suicidality emphasize the role of social factors in the development
      and intensification of suicidal thoughts and behavior, including feeling like a burden on
      family and friends, feelings of isolation and not belonging, and perceptions of diminished
      support from one's family and social network. Despite the critical role of family factors in
      protecting against suicidality, families lack education on how their behavior can help avert
      or unwittingly aggravate suicidal thoughts/ behavior. Families worry about their relative but
      feel uncertain of how to help and need professional guidance. Family worries about
      suicidality are associated with compromised family physical and mental health and
      consequently, diminished ability to offer needed support. Because suicide safety plans rely
      on mobilizing support in times of crisis, families need to be equipped to provide needed
      support.

      Family recommendations from the VA Behavioral Health Autopsy Program (BHAP) Annual Report
      6/30/15 based on interviews with 114 family members highlighted the importance of:

        1. educating families about suicide warning signs:

        2. improving communication between the veteran and family member

        3. involving the family in the veterans' treatment to enhance support and trust

        4. providing families with coaching on how to assist their loved one to seek help.

      Management of suicidal behavior is covered in comprehensive family psychoeducation programs,
      but there is an urgent need for a brief family-based intervention specifically focused on
      suicide prevention that can be used in conjunction with the currently mandated SSP and as a
      part of routine care.

      Despite the enrichment of VA suicide prevention services and implementation of the national
      suicide hotline, Veteran suicide completions have risen to 22 per day and suicide attempts
      numbered over 15,000 in 2012. These data underscore the urgency of developing additional
      interventions targeting suicidal Veterans. One potential avenue to further suicide treatment
      and rehabilitation efforts is to develop strategies that maximize family support, however
      almost no family interventions exist for suicidal Veterans. The construction of a Suicide
      Safety Plan (SSP); a "best practice," is mandated throughout the VA system, and a vital
      component of the VA's coordinated effort at suicide prevention and recovery. The pilot data
      on patterns of SSP use in suicidal Veterans highlighted the importance of sharing the plan
      with family or close friends. However, respondents also noted significant obstacles in their
      ability to reach out to others when in distress. To the knowledge of Investigators, there are
      currently no recommended guidelines or mechanisms for involving family in safety planning,
      despite its inclusion as a step of the plan. "Safe Actions for Families to Encourage
      Recovery" (SAFER) a novel suicide safety planning family intervention has been designed to
      fill this critical gap and provide a mechanism to communicate about safety planning. SAFER, a
      4-session, family intervention, combines education about suicide and suicide safety planning
      with communication skills training from evidence-based practices. The aim is to facilitate
      communication about suicide safety planning and to develop both a Veteran and family member
      safety plan.

      Data from this project will test the intervention's feasibility, acceptability and
      preliminary efficacy in a Stage II small-scale randomized clinical trial in 39 moderate
      suicide risk Veterans and their supporting partners. The comparison condition will be safety
      planning without supporting partner involvement plus weekly check-in phone calls. Primary
      Veteran outcomes include reducing suicidal ideation/behavior. Secondary Veteran outcomes
      include reducing suicidal cognitions (hopelessness, perceived burdensomeness, thwarted
      belongingness) and depression and improving subjective social support. Supporting Partner
      primary outcomes include reducing caregiver burden and secondary outcomes of improving
      suicide-related coping and family empowerment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The individual who evaluates the outcomes of interest will not know the assigned condition of the participants.
measure: Veteran Suicidal Ideation
time frame: POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)
description: Suicidality will be measured using the Columbia Suicide Severity Rating Scale. The C-SSRS was used across time points to record level of ideation, lifetime suicide attempts, and recent suicide attempts. The follow-up version of C-SSRS measured suicidal ideation and behavior that had occurred since the last assessment. The scale has inter-rater reliability of .97 and has been used extensively in prospective suicide studies. The scale has a minimum value of 0 and a maximum value of 5. Higher scores mean a worse outcome (more severe ideation).
measure: Supporting Partner Caregiver Burden
time frame: POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)
description: Caregiver burden will be evaluated by the Caregiver Burden Inventory (CBI), a 24-item scale assessing caregiver burden in four areas: physical, social, emotional and time dependence burden. Investigators found a large effect size in the pilot multifamily group study on this scale (Cohen's d = 1.03). Items were averaged to create an overall measure of caregiver burden and showed excellent internal consistency in this study (α =.94). CBI scores range from 0 (minimum) to 4 (maximum). Higher scores mean a worse outcome (greater caregiver burden).
measure: Number of Veterans With at Least 1 Suicide Attempt
time frame: POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)
description: These are the number of Veterans who reported at least one or more behaviors coded as "actual suicide attempts" since last visit using the Columbia Suicide Severity Rating Scale (C-SSRS). The follow-up version of C-SSRS measured suicidal ideation and behavior that had occurred since the last assessment. The scale has inter-rater reliability of .97 and has been used extensively in prospective suicide studies. A behavior was considered an "actual suicide attempt" if it was a potentially self-injurious act with any intent to die associated with it.
measure: Veteran Suicide Related Coping
time frame: POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)
description: Suicide-related coping will be evaluated by the Stanley Suicide-related Coping Scale (SRCS), a 21-item self-report measure developed by Stanley, Green, Holloway, Brenner & Brown to evaluate appraisal of one's ability to cope with suicidal ideation and urges, as well as ability to use the Safety Plan. Examples of items are: "I am at the mercy of my suicidal thoughts", "I have several things I can do to get through a suicidal crisis". Scores were averaged so that higher scores represent greater confidence and breadth of approaches to coping with suicidal thoughts and feelings (better outcome). SRCS scores have a minimum of 0 and a maximum of 4.
measure: Veteran Thwarted Belongingness
time frame: POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)
description: Thwarted belongingness will be evaluated by Interpersonal Needs Questionnaire (INQ-15). The INQ is has demonstrated acceptable internal consistency for thwarted belongingness in this sample (TB) (α =.79). Scores on each subscale were averaged so that higher scores represent a greater degree of their respective constructs. Thwarted belongingness scores range from 1 (minimum) to 6 (maximum). Higher scores mean a worse outcome (decreased feelings of belongingness).
measure: Partner Support of Suicide-Related Coping
time frame: POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)
description: We have developed a family counterpart to the Stanley Suicide-related Coping Scale for Veterans that taps family members' appraisal of their ability to participate effectively in Veteran safety planning. Items include, "I recognize the triggers and warning signs for suicidal ideation/urges for my Veteran" and "I know the numbers for the mobile crisis team to contact and nearest hospital or urgent care facility to accompany my Veteran to in a crisis." This measure will be validated against the more general Family Empowerment Scale. Items were rated on a 0 (Strongly Disagree) to 4 (Strongly Agree) scale and were averaged with higher scores indicating greater self-efficacy when supporting the Veteran through suicidal crises (better outcome). Partner SRCS scores range from 0 (minimum) to 4 (maximum).
measure: Veteran Perceived Burdensomeness
time frame: POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)
description: Perceived burdensomeness will be evaluated by Interpersonal Needs Questionnaire (INQ-15). The INQ is has demonstrated excellent internal consistency for Perceived Burdensomeness (PB) (α= .95). Scores on each subscale were averaged so that higher scores represent a greater degree of their respective constructs. Perceived burdensomeness scores range from 1 (minimum) to 6 (maximum). Higher scores mean a worse outcome (greater perceived burdensomeness).
measure: Veteran Hopelessness
time frame: POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)
description: Veteran hopelessness will be evaluated by the Beck Hopelessness Scale (BHS), a 20-item self-report measure with adequate reliability and validity which has been predictive of suicide in psychiatric inpatients. The BHS measures three aspects of hopelessness: feelings about the future, loss of motivation, and expectations. Items are true-false and are summed to get a total BHS score, ranging from 0 to 20. Higher scores reflect a worse outcome (greater hopelessness).
measure: Veteran Depression
time frame: POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)
description: Veteran depression will be evaluated by the widely-used Beck Depression Inventory-II (BDI-II) (Cronbach's = .92). The BDI-II contains 21 items assessing depressive symptoms, each with minimum scores of 0 and maximum scores of 3. Item scores were summed, leading to a total score range of 0-63. Higher scores mean a worse outcome (more severe depressive symptoms).
measure: Caregiver's Empowerment to Help Veteran
time frame: POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)
description: Caregiving self-efficacy/empowerment will be evaluated using the 12-item family subscale from the Family Empowerment Scale. This scale assesses the family's knowledge of mental health services and perceived ability to manage crises, and has demonstrated sensitivity to change in family intervention studies. Each item has a minimum score of 1 and a maximum score of 5, and were averaged to create a total score range of 1-5. Higher scores mean a better outcome (greater empowerment).
measure: Veteran's Report of Family Problem Solving
time frame: POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)
description: Veterans' reports of family problem solving will be evaluated by the 5-item Problem Solving subscale of the Family Assessment Device (FAD). Subscales have acceptable internal consistency (α = .72 to .83). Each item has a minimum score of 1 and a maximum score of 4, and were averaged to create a total score range of 1-4. Higher scores reflect worse outcomes (lower problem solving ability).
measure: Veteran's Report of Family Communication
time frame: POST TREATMENT ASSESSMENT- After completing intervention (Range 0.30-7.47 months; Mean=2.84 months from baseline); EXTENDED FOLLOWUP- 3-months after providing follow-up up to 1 year from enrollment (Range 3.10-11.43 months; Mean=6.32 months from baseline)
description: Veterans' reports of family communication will be evaluated by the 6-item Communication subscale of the Family Assessment Device (FAD). Subscales have acceptable internal consistency (α = .72 to .83). Each item has a minimum score of 1 and a maximum score of 4, and were averaged to create a total score range of 1-4. Higher scores reflect worse outcomes (worse communication).
arm group label: SAFER
arm group type: Experimental
description: SAFER (Safe Actions for Families to Encourage Recovery): A novel, 5-session intervention to enhance currently mandated VA suicide safety planning by involving supporting partners to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and supporting partners with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or partner concerns with assurance that such requests will be listened to with validation and support, creating an ally for the suicidal Veteran in his struggle. As discussed above, research has demonstrated compellingly that suicidal desire is motivated by two interpersonal factors; perceived burdensomeness and thwarted belongingness. SAFER aims to increase partner support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.
arm group label: I-SPI
arm group type: Active Comparator
description: The comparison condition will be an assessment-only enhanced treatment-as-usual called the Individual Safety Planning Intervention (I-SPI), incorporating weekly scripted check-in phone calls to review mood symptoms and use of the safety plan, which will then be given as feedback to the Veteran's primary mental health provider.
intervention type: Behavioral
intervention name: Safe Actions for Families to Encourage Recovery
description: A novel, 5-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns with assurance that such requests will be listened to with validation and support, creating an ally for the suicidal Veteran in his struggle. As discussed above, research has demonstrated compellingly that suicidal desire is motivated by two interpersonal factors; perceived burdensomeness and thwarted belongingness. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.
arm group label: SAFER
other name: SAFER
intervention type: Behavioral
intervention name: Individual Safety Planning Intervention
description: The comparison condition will be an assessment-only enhanced treatment-as-usual intervention called the Individual Safety Planning Intervention (I-SPI).
arm group label: I-SPI
other name: I-SPI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Marianne S. Goodman, MD
role: Principal Investigator
affiliation: James J. Peters Veterans Affairs Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Suicide
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The proposed evaluation of SAFER has limitations. First, our strategy only targeted moderate risk suicidal Veterans. Second, there was a relatively small sample size of 39 suicidal Veterans and 39 supporting partners. Third, conducting the study in a high density, urban setting may result in different findings than if conducted in a rural setting. Fourth, the study arms were not matched for treatment dosage (SAFER: 4 sessions versus I-SPI: single session).
point of contact: 