<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/NCT03838198</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00129173</org_study_id>
    <secondary_id>1K23MH113776-01</secondary_id>
    <nct_id>NCT03838198</nct_id>
  </id_info>
  <brief_title>An Adaptive Intervention for Adolescents at Risk for Suicide: A Pilot SMART</brief_title>
  <official_title>Developing an Adaptive Intervention for Suicidal Adolescents Following Inpatient Hospitalization: A Pilot SMART</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To inform the development of a technology-augmented adaptive intervention for adolescents at&#xD;
      risk for suicide, the goal of this study is to conduct a Sequential, Multiple Assignment,&#xD;
      Randomized Trial (SMART) pilot of a Motivational Interview (MI)-enhanced safety planning&#xD;
      intervention (MI-SafeCope). Findings from this study will provide the groundwork for the&#xD;
      construction of a technology-augmented adaptive intervention that could lead to a reduction&#xD;
      in suicidal behaviors and related events during the high-risk post-discharge period-an&#xD;
      important suicide prevention target.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 14, 2019</start_date>
  <completion_date type="Actual">April 7, 2020</completion_date>
  <primary_completion_date type="Actual">April 7, 2020</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>Sequential Assignment</intervention_model>
    <intervention_model_description>This Sequential, Multiple Assignment, Randomized Trial (SMART) pilot of a Motivational Interview (MI)-enhanced safety planning intervention is designed to inform the development of a technology-augmented adaptive intervention for youth at risk for suicide. The MI-SafeCope intervention includes three components: (1) MI-enhanced safety plan delivered during hospitalization (encompassing individual and family meetings); (2) post-discharge booster call; and (3) post-discharge daily text message boosters. In this SMART pilot, adolescents will be randomized to either MI-enhanced safety plan alone or in combination with text boosters for two weeks after discharge (Phase 1 intervention). At the end of week 2, adolescents will be re-randomized to two additional weeks of either: continuation of Phase 1 intervention or continuation of Phase 1 intervention with the addition of post-discharge booster call. Thus, participants will receive one of four treatment sequences (Groups A-D).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Eligible Participants Recruited to the Study</measure>
    <time_frame>At time of study enrollment, measured following study consent/assent</time_frame>
    <description>Eligible participants were candidates for participation based on medical record review who were approached for consent/assent.&#xD;
The percentage of eligible participants who consented to the study is presented below.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability</measure>
    <time_frame>Following intervention, measured up to 1 month</time_frame>
    <description>Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability</measure>
    <time_frame>Following intervention and follow-up assessment, measured up to 3 months</time_frame>
    <description>Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction Ratings Will be Used to Assess Acceptability</measure>
    <time_frame>Following intervention and follow-up assessment, measured up to 3 months</time_frame>
    <description>Satisfaction was scored by responses to two questions: How satisfied were you? on a 4 point scale, where 1 means very dissatisfied and 4 means very satisfied and how likely would you be to recommend this program to a friend in similar circumstances, on the same point scale, where 1 means definitely not and 4 means definitely yes</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Suicide</condition>
  <condition>Self Harm</condition>
  <arm_group>
    <arm_group_label>Safety plan + booster text messages + booster call (Group A)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Safety plan + booster text messages (Group B)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Safety plan + booster call (Group C)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Safety plan (Group D)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MI-Enhanced Safety Plan at Hospitalization (1st Component)</intervention_name>
    <description>The MI-enhanced safety plan intervention component is delivered during hospitalization and includes an individual and family meetings. The goal of the individual meeting with the adolescent is to develop an individualized safety plan for use during a suicidal crisis. This &quot;best practices&quot; approach of safety planning is augmented with Motivational Interviewing (MI) as a core strategy to explicitly elicit adolescents' motivation and commitment to behavior change (i.e. use safety plan; adaptive coping), address barriers or ambivalence, and strengthen self-efficacy. The focus of the family meeting, which is similarly guided by MI, is to prepare parents/guardians, with input from the adolescent, for how they may support the adolescent in implementing the individualized safety plan after discharge and on strengthening parents' commitment and self-efficacy.</description>
    <arm_group_label>Safety plan (Group D)</arm_group_label>
    <arm_group_label>Safety plan + booster call (Group C)</arm_group_label>
    <arm_group_label>Safety plan + booster text messages (Group B)</arm_group_label>
    <arm_group_label>Safety plan + booster text messages + booster call (Group A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MI-Enhanced Text Boosters (2nd Component)</intervention_name>
    <description>For participants randomized to receive text boosters, booster text messages will be sent daily for 4 weeks. The messages will be tailored to encourage use of individualized coping strategies identified as part of safety planning at hospitalization and will include additional adaptive coping tools and resources. The text message content and tone will be consistent with principles of MI.</description>
    <arm_group_label>Safety plan + booster text messages (Group B)</arm_group_label>
    <arm_group_label>Safety plan + booster text messages + booster call (Group A)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MI-Enhanced Booster Call (3rd Component)</intervention_name>
    <description>The focus of the post-discharge booster phone call with adolescent and with parent, each conducted separately, will be to to further adjust the safety plan to better meet post-discharge needs, to further enhance adolescents' motivation and commitment to use coping strategies, and to further support adolescents' and parents' self-efficacy to manage suicidal crises.</description>
    <arm_group_label>Safety plan + booster call (Group C)</arm_group_label>
    <arm_group_label>Safety plan + booster text messages + booster call (Group A)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suicide attempt (previous month), and/or&#xD;
&#xD;
          -  Suicidal ideation (previous week)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive impairment or altered mental status (psychosis, manic state)&#xD;
&#xD;
          -  Transfer to medical unit or residential placement&#xD;
&#xD;
          -  No availability of a legal guardian&#xD;
&#xD;
          -  No cell phone with text messaging capability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ewa Czyz</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <results_first_submitted>April 7, 2021</results_first_submitted>
  <results_first_submitted_qc>May 6, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 28, 2021</results_first_posted>
  <last_update_submitted>May 6, 2021</last_update_submitted>
  <last_update_submitted_qc>May 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Ewa Czyz</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Adaptive Intervention</keyword>
  <keyword>Sequential, Multiple Assignment, Randomized Trial (SMART)</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Motivational Interviewing</keyword>
  <keyword>Suicide attempt</keyword>
  <keyword>Safety planning</keyword>
  <keyword>mobile technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Self-Injurious Behavior</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>March 21, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03838198/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of a larger number of hospital admissions records reviewed, 94 persons were deemed &quot;eligible&quot; and were approached. 82 consented to participate in the trial, of whom, two participants were consented but excluded prior to randomization because they were discharged early.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Safety Plan + Booster Text Messages + Booster Call</title>
          <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies -- which will be followed by 4 weeks of daily post-discharge booster text messages and in Period/Phase 2 a phone booster call.</description>
        </group>
        <group group_id="P2">
          <title>Safety Plan + Booster Text Messages</title>
          <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge without booster phone call.</description>
        </group>
        <group group_id="P3">
          <title>Safety Plan + Booster Call</title>
          <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.</description>
        </group>
        <group group_id="P4">
          <title>Safety Plan</title>
          <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization with neither follow-up text messages nor booster phone call.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Phase 1: Safety Plan (SP) vs. SP w/Texts</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">Because it was a SMART trial, no participants were allocated to receive booster calls until Phase 2.</participants>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="0">Because it was a SMART trial, no participants were allocated to receive booster calls until Phase 2.</participants>
                <participants group_id="P4" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Phase 2: Added Booster Call or Not</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18">These participants continued with Phase 1 intervention (Safety plan and text) with added booster call.</participants>
                <participants group_id="P2" count="22">These participants continued with Phase 1 intervention (Safety plan and text) with no added booster call.</participants>
                <participants group_id="P3" count="18">These participants continued with Phase 1 intervention (Safety plan only) with added booster call.</participants>
                <participants group_id="P4" count="22">These participants continued with Phase 1 intervention (Safety plan only) with no added booster call in Phase 2</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18">All 18 completed the safety plan; but only 14 had both parent and adolescent completing the call; 1 had parent only; 1 had adolescent only; 2 were unable to be reached.</participants>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="17">Of the 17 who completed the safety plan, only 15 had both parent and adolescent completing the call; 1 had parent only; 1 was unable to be reached.</participants>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="22"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>In this SMART trial design, this group was randomized to &quot;no booster call.</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>1 Month Follow up Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="22">All participants from Phase 1 and 2 were followed unless they withdrew.</participants>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="22">All participants from Phase 1 and 2 were followed unless they withdrew.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Adolescent Surveys Completed</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>3 Month Follow up Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Adolescent Survey Completed</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Phase 1 assigned all 80 participants to safety plan(SP) or SP+text. Phase 2 added booster calls vs. no calls to Phase 1 interventions. Each participant of the 80 is fully included in the two groups shown here. For race, some participants self-described in &gt;1 category, not as &quot;More than 1 race&quot;. Thus the totals of participants' self-descriptions for race in each column exceed the actual 40 people shown in other baseline measures.</population>
      <group_list>
        <group group_id="B1">
          <title>Phase 1 - Safety Plan</title>
          <description>Participants who received the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies</description>
        </group>
        <group group_id="B2">
          <title>Phase 1 - Safety Plan &amp; Text Messages</title>
          <description>Participants who received the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.</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="41"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="83"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>This is the actual number of participants assigned to this group</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="40"/>
                    <count group_id="B2" value="40"/>
                    <count group_id="B3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.08" spread="1.4"/>
                    <measurement group_id="B2" value="15.25" spread="1.32"/>
                    <measurement group_id="B3" value="15.16" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>This is the actual number of participants assigned to this group</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="40"/>
                    <count group_id="B2" value="40"/>
                    <count group_id="B3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>For race, some of the 40 participants assigned to each safety plan group self-described as more than one category, but not as &quot;More than one race&quot; . Thus the totals of participants' self-descriptions for race in each column total more than the overall number of baseline participants.</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="41"/>
                    <count group_id="B2" value="42"/>
                    <count group_id="B3" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="67"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Count of participants with at least one suicide attempt during their lifetime</title>
          <population>This is the actual number of participants assigned to this group</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="40"/>
                    <count group_id="B2" value="40"/>
                    <count group_id="B3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Last-month suicide attempt</title>
          <population>This is the actual number of participants assigned to this group</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="40"/>
                    <count group_id="B2" value="40"/>
                    <count group_id="B3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Multiple attempt history</title>
          <population>This is the actual number of participants assigned to this group</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="40"/>
                    <count group_id="B2" value="40"/>
                    <count group_id="B3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lifetime nonsuicidal self-injury</title>
          <population>This is the actual number of participants assigned to this group</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="40"/>
                    <count group_id="B2" value="40"/>
                    <count group_id="B3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Suicidal ideation mean</title>
          <description>Suicidal Ideation (Columbia-Suicide Severity Rating Scale (C-SSRS)) is scored on a range from 0 (no suicidal ideation) to 5 (suicidal ideation with plan and intent).</description>
          <population>This is the actual number of participants assigned to this group</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="40"/>
                    <count group_id="B2" value="40"/>
                    <count group_id="B3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.90" spread=".90"/>
                    <measurement group_id="B2" value="3.93" spread="0.92"/>
                    <measurement group_id="B3" value="3.91" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Common Diagnoses</title>
          <population>This is the actual number of participants assigned to this group</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Depressive disorder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="40"/>
                    <count group_id="B3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety disorder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="40"/>
                    <count group_id="B2" value="40"/>
                    <count group_id="B3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Eligible Participants Recruited to the Study</title>
        <description>Eligible participants were candidates for participation based on medical record review who were approached for consent/assent.&#xD;
The percentage of eligible participants who consented to the study is presented below.</description>
        <time_frame>At time of study enrollment, measured following study consent/assent</time_frame>
        <population>Eligible youth whether consent was provided or not</population>
        <group_list>
          <group group_id="O1">
            <title>All Eligible Youth</title>
            <description>Potential participants prior to randomization</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eligible Participants Recruited to the Study</title>
          <description>Eligible participants were candidates for participation based on medical record review who were approached for consent/assent.&#xD;
The percentage of eligible participants who consented to the study is presented below.</description>
          <population>Eligible youth whether consent was provided or not</population>
          <units>Percentage of eligible participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability</title>
        <description>Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability</description>
        <time_frame>Following intervention, measured up to 1 month</time_frame>
        <population>No texts and boosters were planned for the associated data fields</population>
        <group_list>
          <group group_id="O1">
            <title>Safety Plan + Booster Text Messages + Booster Call (Group A)</title>
            <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.</description>
          </group>
          <group group_id="O2">
            <title>Safety Plan + Booster Text Messages (Group B)</title>
            <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.</description>
          </group>
          <group group_id="O3">
            <title>Safety Plan + Booster Call (Group C)</title>
            <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.</description>
          </group>
          <group group_id="O4">
            <title>Safety Plan (Group D)</title>
            <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability</title>
          <description>Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability</description>
          <population>No texts and boosters were planned for the associated data fields</population>
          <units>percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Safety Plan (Phase 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="18"/>
                    <count group_id="O4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Booster Texts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Booster Call (Phase 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="18"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.9"/>
                    <measurement group_id="O3" value="88.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability</title>
        <description>Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability</description>
        <time_frame>Following intervention and follow-up assessment, measured up to 3 months</time_frame>
        <population>Intent to treat analysis includes all participants assigned</population>
        <group_list>
          <group group_id="O1">
            <title>Safety Plan + Booster Text Messages + Booster Call (Group A)</title>
            <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.</description>
          </group>
          <group group_id="O2">
            <title>Safety Plan + Booster Text Messages (Group B)</title>
            <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.</description>
          </group>
          <group group_id="O3">
            <title>Safety Plan + Booster Call (Group C)</title>
            <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.</description>
          </group>
          <group group_id="O4">
            <title>Safety Plan (Group D)</title>
            <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability</title>
          <description>Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability</description>
          <population>Intent to treat analysis includes all participants assigned</population>
          <units>percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="94.4"/>
                    <measurement group_id="O4" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Satisfaction Ratings Will be Used to Assess Acceptability</title>
        <description>Satisfaction was scored by responses to two questions: How satisfied were you? on a 4 point scale, where 1 means very dissatisfied and 4 means very satisfied and how likely would you be to recommend this program to a friend in similar circumstances, on the same point scale, where 1 means definitely not and 4 means definitely yes</description>
        <time_frame>Following intervention and follow-up assessment, measured up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Safety Plan + Booster Text Messages + Booster Call (Group A)</title>
            <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.</description>
          </group>
          <group group_id="O2">
            <title>Safety Plan + Booster Text Messages (Group B)</title>
            <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.</description>
          </group>
          <group group_id="O3">
            <title>Safety Plan + Booster Call (Group C)</title>
            <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.</description>
          </group>
          <group group_id="O4">
            <title>Safety Plan (Group D)</title>
            <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction Ratings Will be Used to Assess Acceptability</title>
          <description>Satisfaction was scored by responses to two questions: How satisfied were you? on a 4 point scale, where 1 means very dissatisfied and 4 means very satisfied and how likely would you be to recommend this program to a friend in similar circumstances, on the same point scale, where 1 means definitely not and 4 means definitely yes</description>
          <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="17"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Satisfaction score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.59" spread="0.51"/>
                    <measurement group_id="O2" value="3.55" spread="0.51"/>
                    <measurement group_id="O3" value="3.31" spread="0.79"/>
                    <measurement group_id="O4" value="3.55" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Likelihood of recommending plan to a friend score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.82" spread="0.39"/>
                    <measurement group_id="O2" value="3.77" spread="0.43"/>
                    <measurement group_id="O3" value="3.38" spread="0.81"/>
                    <measurement group_id="O4" value="3.64" spread="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data on suicide attempts was collected over a 3 month period.</time_frame>
      <desc>Since all participants were hospitalized for suicide risk (ideation or attempts) to be eligible, those who were unreachable at follow-up weren't included in denominators of suicide attempt data, as they couldn't be presumed to have attempted suicide nor could they be presumed with certainty not to have attempted suicide. Thus it is most accurate to report only known data that is based on collected AEs. Non-serious Adverse Events were not collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Safety Plan + Booster Text Messages + Booster Call (Group A)</title>
          <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.</description>
        </group>
        <group group_id="E2">
          <title>Safety Plan + Booster Text Messages (Group B)</title>
          <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.</description>
        </group>
        <group group_id="E3">
          <title>Safety Plan + Booster Call (Group C)</title>
          <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.</description>
        </group>
        <group group_id="E4">
          <title>Safety Plan (Group D)</title>
          <description>Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicide Attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="20"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="0"/>
              </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>
    <point_of_contact>
      <name_or_title>Ewa Czyz</name_or_title>
      <organization>University of Michigan</organization>
      <phone>734-764-9466</phone>
      <email>ewac@umich.edu</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/NCT03838198
org study id: HUM00129173
secondary id: 1K23MH113776-01
nct id: NCT03838198
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
To inform the development of a technology-augmented adaptive intervention for adolescents at
      risk for suicide, the goal of this study is to conduct a Sequential, Multiple Assignment,
      Randomized Trial (SMART) pilot of a Motivational Interview (MI)-enhanced safety planning
      intervention (MI-SafeCope). Findings from this study will provide the groundwork for the
      construction of a technology-augmented adaptive intervention that could lead to a reduction
      in suicidal behaviors and related events during the high-risk post-discharge period-an
      important suicide prevention target.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: This Sequential, Multiple Assignment, Randomized Trial (SMART) pilot of a Motivational Interview (MI)-enhanced safety planning intervention is designed to inform the development of a technology-augmented adaptive intervention for youth at risk for suicide. The MI-SafeCope intervention includes three components: (1) MI-enhanced safety plan delivered during hospitalization (encompassing individual and family meetings); (2) post-discharge booster call; and (3) post-discharge daily text message boosters. In this SMART pilot, adolescents will be randomized to either MI-enhanced safety plan alone or in combination with text boosters for two weeks after discharge (Phase 1 intervention). At the end of week 2, adolescents will be re-randomized to two additional weeks of either: continuation of Phase 1 intervention or continuation of Phase 1 intervention with the addition of post-discharge booster call. Thus, participants will receive one of four treatment sequences (Groups A-D).
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Eligible Participants Recruited to the Study
time frame: At time of study enrollment, measured following study consent/assent
description: Eligible participants were candidates for participation based on medical record review who were approached for consent/assent.
The percentage of eligible participants who consented to the study is presented below.
measure: Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability
time frame: Following intervention, measured up to 1 month
description: Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability
measure: Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability
time frame: Following intervention and follow-up assessment, measured up to 3 months
description: Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability
measure: Satisfaction Ratings Will be Used to Assess Acceptability
time frame: Following intervention and follow-up assessment, measured up to 3 months
description: Satisfaction was scored by responses to two questions: How satisfied were you? on a 4 point scale, where 1 means very dissatisfied and 4 means very satisfied and how likely would you be to recommend this program to a friend in similar circumstances, on the same point scale, where 1 means definitely not and 4 means definitely yes
arm group label: Safety plan + booster text messages + booster call (Group A)
arm group type: Other
description: Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.
arm group label: Safety plan + booster text messages (Group B)
arm group type: Other
description: Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.
arm group label: Safety plan + booster call (Group C)
arm group type: Other
description: Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.
arm group label: Safety plan (Group D)
arm group type: Other
description: Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization.
intervention type: Behavioral
intervention name: MI-Enhanced Safety Plan at Hospitalization (1st Component)
description: The MI-enhanced safety plan intervention component is delivered during hospitalization and includes an individual and family meetings. The goal of the individual meeting with the adolescent is to develop an individualized safety plan for use during a suicidal crisis. This "best practices" approach of safety planning is augmented with Motivational Interviewing (MI) as a core strategy to explicitly elicit adolescents' motivation and commitment to behavior change (i.e. use safety plan; adaptive coping), address barriers or ambivalence, and strengthen self-efficacy. The focus of the family meeting, which is similarly guided by MI, is to prepare parents/guardians, with input from the adolescent, for how they may support the adolescent in implementing the individualized safety plan after discharge and on strengthening parents' commitment and self-efficacy.
arm group label: Safety plan (Group D)
arm group label: Safety plan + booster call (Group C)
arm group label: Safety plan + booster text messages (Group B)
arm group label: Safety plan + booster text messages + booster call (Group A)
intervention type: Behavioral
intervention name: MI-Enhanced Text Boosters (2nd Component)
description: For participants randomized to receive text boosters, booster text messages will be sent daily for 4 weeks. The messages will be tailored to encourage use of individualized coping strategies identified as part of safety planning at hospitalization and will include additional adaptive coping tools and resources. The text message content and tone will be consistent with principles of MI.
arm group label: Safety plan + booster text messages (Group B)
arm group label: Safety plan + booster text messages + booster call (Group A)
intervention type: Behavioral
intervention name: MI-Enhanced Booster Call (3rd Component)
description: The focus of the post-discharge booster phone call with adolescent and with parent, each conducted separately, will be to to further adjust the safety plan to better meet post-discharge needs, to further enhance adolescents' motivation and commitment to use coping strategies, and to further support adolescents' and parents' self-efficacy to manage suicidal crises.
arm group label: Safety plan + booster call (Group C)
arm group label: Safety plan + booster text messages + booster call (Group A)
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: No
last name: Ewa Czyz
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Ewa Czyz
investigator title: Assistant Professor
mesh term: Suicide
mesh term: Self-Injurious Behavior
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 