<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/NCT03246646</url>
  </required_header>
  <id_info>
    <org_study_id>D2070-P</org_study_id>
    <nct_id>NCT03246646</nct_id>
  </id_info>
  <brief_title>Telephone Coaching of Family Members of Veterans With Substance Abuse Problems</brief_title>
  <acronym>VA-CRAFT</acronym>
  <official_title>Telephone Coaching of Family Members of Veterans With Substance Abuse Problems</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>
      This project will develop and pilot test an enhanced, telephone &quot;coaching&quot; intervention to&#xD;
      help family members concerned about a Veteran of the wars in Iraq or Afghanistan who needs to&#xD;
      seek treatment for a substance abuse problem.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will first develop a detailed manual for Coaching-CRAFT, which will be a&#xD;
      telephone-based model of coaching that uses the web-version of an intervention already&#xD;
      developed and available to the investigators. The investigators will conduct a preliminary&#xD;
      nonrandomized feasibility trial of the use of Coaching-CRAFT with a sample of 50 family&#xD;
      member callers recruited from VA's Coaching Into Care call center. Later in the study, the&#xD;
      investigators will recruit up to 50 Veterans whose family members also participated in this&#xD;
      study. Since the 'Coaching Into Care' telephone-based call center located at the Corporal&#xD;
      Michael J. Crescenz VA Medical Center (CMCVAMC) is a national call center, study subjects&#xD;
      (non-Veterans and Veterans) will be from all parts of the United States.&#xD;
&#xD;
      Family members (spouses, siblings, or parents) of Veteran will be recruited from Coaching&#xD;
      Into Care, and offered telephone-based coaching to the family member regarding their concern&#xD;
      that the Veteran has a substance abuse problem and does not want to seek treatment. The&#xD;
      program will involve approximately 12 telephone calls over 4-6 months. Family members will be&#xD;
      assessed for their own mental health symptoms, their perception of their Veteran's mental&#xD;
      health symptoms and substance use, his or her treatment, as well as their perception of&#xD;
      burden on the relationship with the Veteran. These assessments will occur at study entry, 6&#xD;
      months, and 12 months after study entry. Veteran's perceptions of the intervention will be&#xD;
      sought at 12 months, whenever safe and practical. For Veterans who are not approached to&#xD;
      participate in the study, VHA administrative data will be sought through a HIPAA Waiver to&#xD;
      confirm any possible mental health and or substance abuse treatment the Veteran has received.&#xD;
      Rates of initiation of treatment will be compared to QA data from the Coaching Into Care call&#xD;
      center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2017</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The intervention will be approximately 12, 30-45 min. telephone sessions, every 2-3 weeks, and will last 4-6 months. The Coach helps the participant individualize the content of a web-based course (VA-CRAFT) based on an intervention to encourage a loved one to seek treatment for substance abuse. The VA-CRAFT course has 8 modules that follow the original CRAFT intervention: 1) Introduction, 2) Overview, 3) Getting Started: Safety Planning, 4) Understanding substance abuse, 5) How to respond to substance abuse, 6) Rebuilding your life together, 7) Helping someone consider treatment, 8) Wrapping up. The goals include understanding triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and how to help the CSO caller help the Veteran enter treatment. The participants in the active intervention will be compared to a treatment as usual, matched comparator group drawn from regular clinical operations.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Veteran's Engaged in Mental Health Care</measure>
    <time_frame>At any point during study involvement, up to 1 year after enrollment</time_frame>
    <description>Veteran's mental health care engagement was assessed from CSO participants' report.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Substance Abuse</condition>
  <arm_group>
    <arm_group_label>Coaching + VA CRAFT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telephone coaching along with web-based CRAFT course</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment as usual matched comparison</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Coaching</intervention_name>
    <description>Telephone coaching was provided in a series of telephone based sessions with CSO participants</description>
    <arm_group_label>Coaching + VA CRAFT</arm_group_label>
    <arm_group_label>Treatment as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CSO is a sibling, spouse/ intimate partner, or parent of a US military Veteran who&#xD;
             served in Iraq or Afghanistan since 2001&#xD;
&#xD;
          -  by the report of the CSO the Veteran of interest has a substance abuse problem that&#xD;
             has led to interpersonal, legal, occupational, and/or health related negative&#xD;
             consequences&#xD;
&#xD;
          -  the CSO reports that the Veteran is not currently receiving treatment for this problem&#xD;
&#xD;
          -  the CSO has contact 4+times/week and lives with or within 30 min. of the Veteran.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CSO has a SUD (Form 90, see Measures)&#xD;
&#xD;
          -  the Veteran is currently incarcerated&#xD;
&#xD;
          -  the CSO has no computer or other device with Internet access able to view video&#xD;
             content&#xD;
&#xD;
          -  the CSO or Veteran likely has a psychotic disorder (CSO report on the MINI) (see&#xD;
             Measures)&#xD;
&#xD;
          -  the CSO's involvement in a &quot;coaching&quot; intervention meant to encourage the Veteran to&#xD;
             actively consider to seek care places the CSO at risk on a physical or psychological&#xD;
             basis&#xD;
&#xD;
          -  Callers who do not have access to a safe phone line will not be referred to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven L. Sayers, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Epidemiology Program: Post-Deployment Health Group, Analysis of VA Health Care Utilization among Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans: Cumulative from 1st Qtr FY 2002 through 4th Qtr FY 2014 (October 1, 2001 - September 30, 2014), Office of Public Health, Editor. 2015, Department of Veterans Affairs: Washington, DC. https://www.publichealth.va.gov/docs/epidemiology/healthcare-utilization-report-fy2015-qtr1.pdf</citation>
  </reference>
  <reference>
    <citation>Seal KH, Cohen G, Waldrop A, Cohen BE, Maguen S, Ren L. Substance use disorders in Iraq and Afghanistan veterans in VA healthcare, 2001-2010: Implications for screening, diagnosis and treatment. Drug Alcohol Depend. 2011 Jul 1;116(1-3):93-101. doi: 10.1016/j.drugalcdep.2010.11.027. Epub 2011 Jan 31.</citation>
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    <PMID>16157233</PMID>
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    <citation>Batten S, Drapalski L, Decker L, DeViva C, Morris J, Mann A, Dixon B. Veteran interest in family involvement in PTSD treatment. Psychol Serv. 2009 Aug 10;6(3):184-189. doi: 10.1037/a0015392.</citation>
    <PMID>30328689</PMID>
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    <citation>Hershenberg R, Mavandadi S, Klaus JR, Oslin DW, Sayers SL. Veteran preferences for romantic partner involvement in depression treatment. Gen Hosp Psychiatry. 2014 Nov-Dec;36(6):757-9. doi: 10.1016/j.genhosppsych.2014.08.001. Epub 2014 Aug 16.</citation>
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    <citation>Sayers SL, White T, Zubritsky C, Oslin DW. Family involvement in the care of healthy medical outpatients. Fam Pract. 2006 Jun;23(3):317-24. doi: 10.1093/fampra/cmi114. Epub 2006 Feb 3.</citation>
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    <citation>Meyers RJ, Roozen HG, Smith JE. The community reinforcement approach: an update of the evidence. Alcohol Res Health. 2011;33(4):380-8.</citation>
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    <citation>Roozen HG, de Waart R, van der Kroft P. Community reinforcement and family training: an effective option to engage treatment-resistant substance-abusing individuals in treatment. Addiction. 2010 Oct;105(10):1729-38. doi: 10.1111/j.1360-0443.2010.03016.x. Erratum In: Addiction. 2010 Nov;105(11):2040.</citation>
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    <citation>McKay JR, Van Horn D, Oslin DW, Ivey M, Drapkin ML, Coviello DM, Yu Q, Lynch KG. Extended telephone-based continuing care for alcohol dependence: 24-month outcomes and subgroup analyses. Addiction. 2011 Oct;106(10):1760-9. doi: 10.1111/j.1360-0443.2011.03483.x. Epub 2011 Aug 8.</citation>
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    <citation>McKay JR, Van Horn DH, Oslin DW, Lynch KG, Ivey M, Ward K, Drapkin ML, Becher JR, Coviello DM. A randomized trial of extended telephone-based continuing care for alcohol dependence: within-treatment substance use outcomes. J Consult Clin Psychol. 2010 Dec;78(6):912-23. doi: 10.1037/a0020700.</citation>
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    <citation>McKay JR, Lynch KG, Shepard DS, Ratichek S, Morrison R, Koppenhaver J, Pettinati HM. The effectiveness of telephone-based continuing care in the clinical management of alcohol and cocaine use disorders: 12-month outcomes. J Consult Clin Psychol. 2004 Dec;72(6):967-79. doi: 10.1037/0022-006X.72.6.967.</citation>
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    <citation>Miller WR, Del Boca FK. Measurement of drinking behavior using the Form 90 family of instruments. J Stud Alcohol Suppl. 1994 Dec;12:112-8. doi: 10.15288/jsas.1994.s12.112.</citation>
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    <citation>Weathers, F.W., J.A. Huska, and T.M. Keane, PCL-C for DSM-IV. 1991, Boston: National Center for PTSD - Behavioral Science Division.</citation>
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    <citation>Rosner, B., Fundamentals of Biostatistics. 2011, Boston: Brooks/Cole.</citation>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <results_first_submitted>March 10, 2021</results_first_submitted>
  <results_first_submitted_qc>June 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 30, 2021</results_first_posted>
  <last_update_submitted>June 9, 2021</last_update_submitted>
  <last_update_submitted_qc>June 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Substance Abuse</keyword>
  <keyword>Alcohol Abuse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</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>September 8, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03246646/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 26, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03246646/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Potential participants were recruited from the callers who reached a staff member of the Coaching Into Care (CIC) program. Those interested in considering the research study were screened by a study staff member, consented if eligible, and given a baseline assessment. Some participants responded to notices on social media who filled out a brief online screener or contact study staff directly. The matched TAU control participants were selected from callers to CIC in the same time period.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Coaching + VA-CRAFT</title>
          <description>The interventionist provided a telephone-guided coaching intervention with the aid of a web-based program, VA-CRAFT, developed by the Co-Investigators for concerned significant others (CSOs). The VA-CRAFT program, based on the original Community Reinforcement and Family Training (CRAFT) program for substance misuse has 8 modules: 1) Introduction to CRAFT, 2) Overview of CRAFT, 3) Getting Started with CRAFT: Safety Planning, 4) Understanding substance abuse, 5) How to respond to substance abuse, 6) How to rebuild your life together, 7) How to help someone consider treatment, 8) Wrapping up. The goals of the intervention include helping the CSO understand triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and encouraging the Veteran to enter mental health treatment for substance abuse. After viewing each of the VA-CRAFT web-based modules, the interventionist reviewed and personalized the material with the CSO via a telephone conversation. The intervention was flexible within the following framework: 1) 8 to 12, 30-45 min. telephone sessions, every 2-3 weeks, and 2) between 4 and 6 months.</description>
        </group>
        <group group_id="P2">
          <title>Treatment as Usual (TAU) Coaching</title>
          <description>The treatment as usual coaching (TAU) seeks to empower, motivate, educate, and improved the concerned significant others' (CSOs') listening and communication skills with the goal of enhancing the veteran's intrinsic motivation for care. It draws from self-determination theory and emphasizes humans' underlying need for autonomy to maximize intrinsic motivation. CSOs were encouraged to reduce their pressure on the veteran to seek care and to engage in more positive activities of interest to both. CSOs were coached to listen for concerns expressed by the veteran, such as complaints about mood, anxiety, or the future (11, 12). CSOs were also encouraged to use an &quot;autonomy-supportive&quot; style of communication, which means offering to help the veteran but stating that it is understood that the offer is subject to the veteran welcoming this assistance. Coaching includes behavioral rehearsal to enhance the learning of these skills.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15">15 participants completed either 6-month or 12-month follow-up or both.</participants>
                <participants group_id="P2" count="26">Follow-up was limited to chart follow-up in CIC services</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>deemed ineligible and administratively withdrawn</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Coaching + VA-CRAFT</title>
          <description>The interventionist provided a telephone-guided coaching intervention with the aid of a web-based program, VA-CRAFT, developed by the Co-Investigators for concerned significant others (CSOs). The VA-CRAFT program, based on the original Community Reinforcement and Family Training (CRAFT) program for substance misuse has 8 modules: 1) Introduction to CRAFT, 2) Overview of CRAFT, 3) Getting Started with CRAFT: Safety Planning, 4) Understanding substance abuse, 5) How to respond to substance abuse, 6) How to rebuild your life together, 7) How to help someone consider treatment, 8) Wrapping up. The goals of the intervention include helping the CSO understand triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and encouraging the Veteran to enter mental health treatment for substance abuse. After viewing each of the VA-CRAFT web-based modules, the interventionist reviewed and personalized the material with the CSO via a telephone conversation. The intervention was flexible within the following framework: 1) 8 to 12, 30-45 min. telephone sessions, every 2-3 weeks, and 2) between 4 and 6 months.</description>
        </group>
        <group group_id="B2">
          <title>Treatment as Usual (TAU) Coaching</title>
          <description>The treatment as usual coaching (TAU) seeks to empower, motivate, educate, and improved the concerned significant others' (CSOs') listening and communication skills with the goal of enhancing the veteran's intrinsic motivation for care. It draws from self-determination theory and emphasizes humans' underlying need for autonomy to maximize intrinsic motivation. CSOs were encouraged to reduce their pressure on the veteran to seek care and to engage in more positive activities of interest to both. CSOs were coached to listen for concerns expressed by the veteran, such as complaints about mood, anxiety, or the future (11, 12). CSOs were also encouraged to use an &quot;autonomy-supportive&quot; style of communication, which means offering to help the veteran but stating that it is understood that the offer is subject to the veteran welcoming this assistance. Coaching includes behavioral rehearsal to enhance the learning of these skills.</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="26"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="52"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Measure Analysis Population Description: Age reported of caller participant (CSO) reported for Coaching + VA CRAFT group only. Age not assessed for TAU Coaching group (usual care).</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="26"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.6" spread="7.9"/>
                    <measurement group_id="B3" value="37.6" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <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="26"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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>Race was not assessed for CSO's included in the TAU matched comparison group since race was not collected as part of usual clinical operations.</description>
          <population>Race was not collected as part of TAU data collection for clinical purposes.</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="26"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="26"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>Native Hawaiian or Other Pacific Islander</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>Black or African American</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>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Veteran's engagement in MH Care at Baseline</title>
          <description>As reported by CSO, the engagement of Veteran in MH Care at the baseline assessment, also reflecting that the Veteran was not engaged in MH care within the previous 6 months prior to the onset of study period.</description>
          <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="26"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <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>Relationship</title>
          <description>Relationship of CSO to the Veteran: spouse/intimate other, sibling, parent</description>
          <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="26"/>
                    <count group_id="B2" value="26"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Spouses/intimate other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sibling</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>Parent</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Veteran's Engaged in Mental Health Care</title>
        <description>Veteran's mental health care engagement was assessed from CSO participants' report.</description>
        <time_frame>At any point during study involvement, up to 1 year after enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Coaching + VA CRAFT</title>
            <description>Telephone coaching along with web-based CRAFT course&#xD;
Coaching: Telephone coaching was provided in a series of telephone based sessions with CSO participants</description>
          </group>
          <group group_id="O2">
            <title>Treatment as Usual</title>
            <description>Treatment as usual matched comparison&#xD;
Coaching: Telephone coaching was provided in a series of telephone based sessions with CSO participants</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Veteran's Engaged in Mental Health Care</title>
          <description>Veteran's mental health care engagement was assessed from CSO participants' report.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </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>&gt;.05</p_value>
            <method>Z test of independent proportions</method>
            <param_type>Z test of proportions</param_type>
            <param_value>0.66</param_value>
            <ci_n_sides>1-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The investigators assessed for adverse events for the 1 year duration of participation for every participant in the study.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Coaching + VA CRAFT</title>
          <description>Telephone coaching along with web-based CRAFT course&#xD;
Coaching: Telephone coaching was provided in a series of telephone based sessions with CSO participants</description>
        </group>
        <group group_id="E2">
          <title>Treatment as Usual</title>
          <description>Treatment as usual matched comparison&#xD;
Coaching: Telephone coaching was provided in a series of telephone based sessions with CSO participants</description>
        </group>
      </group_list>
      <serious_events>
        <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="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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 limitations of the design include that this was a pilot study with a primary goal of examining the feasibility of the intervention rather than determine the efficacy of the intervention. The treatment as usual comparison group served only as a benchmark for understanding the potential effectiveness.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Steven L. Sayers</name_or_title>
      <organization>CMC VA Medical Center</organization>
      <phone>(215) 823-5196</phone>
      <email>steven.sayers@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/NCT03246646
org study id: D2070-P
nct id: NCT03246646
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This project will develop and pilot test an enhanced, telephone "coaching" intervention to
      help family members concerned about a Veteran of the wars in Iraq or Afghanistan who needs to
      seek treatment for a substance abuse problem.
The investigators will first develop a detailed manual for Coaching-CRAFT, which will be a
      telephone-based model of coaching that uses the web-version of an intervention already
      developed and available to the investigators. The investigators will conduct a preliminary
      nonrandomized feasibility trial of the use of Coaching-CRAFT with a sample of 50 family
      member callers recruited from VA's Coaching Into Care call center. Later in the study, the
      investigators will recruit up to 50 Veterans whose family members also participated in this
      study. Since the 'Coaching Into Care' telephone-based call center located at the Corporal
      Michael J. Crescenz VA Medical Center (CMCVAMC) is a national call center, study subjects
      (non-Veterans and Veterans) will be from all parts of the United States.

      Family members (spouses, siblings, or parents) of Veteran will be recruited from Coaching
      Into Care, and offered telephone-based coaching to the family member regarding their concern
      that the Veteran has a substance abuse problem and does not want to seek treatment. The
      program will involve approximately 12 telephone calls over 4-6 months. Family members will be
      assessed for their own mental health symptoms, their perception of their Veteran's mental
      health symptoms and substance use, his or her treatment, as well as their perception of
      burden on the relationship with the Veteran. These assessments will occur at study entry, 6
      months, and 12 months after study entry. Veteran's perceptions of the intervention will be
      sought at 12 months, whenever safe and practical. For Veterans who are not approached to
      participate in the study, VHA administrative data will be sought through a HIPAA Waiver to
      confirm any possible mental health and or substance abuse treatment the Veteran has received.
      Rates of initiation of treatment will be compared to QA data from the Coaching Into Care call
      center.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The intervention will be approximately 12, 30-45 min. telephone sessions, every 2-3 weeks, and will last 4-6 months. The Coach helps the participant individualize the content of a web-based course (VA-CRAFT) based on an intervention to encourage a loved one to seek treatment for substance abuse. The VA-CRAFT course has 8 modules that follow the original CRAFT intervention: 1) Introduction, 2) Overview, 3) Getting Started: Safety Planning, 4) Understanding substance abuse, 5) How to respond to substance abuse, 6) Rebuilding your life together, 7) Helping someone consider treatment, 8) Wrapping up. The goals include understanding triggers and long-term reinforcement of substance misuse, ignoring unhealthy behaviors and rewarding healthy behaviors, getting support, and how to help the CSO caller help the Veteran enter treatment. The participants in the active intervention will be compared to a treatment as usual, matched comparator group drawn from regular clinical operations.
primary purpose: Other
masking: None (Open Label)
measure: Number of Veteran's Engaged in Mental Health Care
time frame: At any point during study involvement, up to 1 year after enrollment
description: Veteran's mental health care engagement was assessed from CSO participants' report.
arm group label: Coaching + VA CRAFT
arm group type: Experimental
description: Telephone coaching along with web-based CRAFT course
arm group label: Treatment as usual
arm group type: Other
description: Treatment as usual matched comparison
intervention type: Behavioral
intervention name: Coaching
description: Telephone coaching was provided in a series of telephone based sessions with CSO participants
arm group label: Coaching + VA CRAFT
arm group label: Treatment as usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven L. Sayers, PhD
role: Principal Investigator
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
facility: 
country: United States
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citation: Savundranayagam MY, Montgomery RJ, Kosloski K. A dimensional analysis of caregiver burden among spouses and adult children. Gerontologist. 2011 Jun;51(3):321-31. doi: 10.1093/geront/gnq102. Epub 2010 Dec 6.
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responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The limitations of the design include that this was a pilot study with a primary goal of examining the feasibility of the intervention rather than determine the efficacy of the intervention. The treatment as usual comparison group served only as a benchmark for understanding the potential effectiveness.
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