<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/NCT03014271</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201702833</org_study_id>
    <secondary_id>2016-U-0436</secondary_id>
    <secondary_id>1U01CE002841-01</secondary_id>
    <secondary_id>GRANT12174446</secondary_id>
    <nct_id>NCT03014271</nct_id>
  </id_info>
  <brief_title>Primary Prevention Youth Suicide Trial in Colorado High Schools Prevention Among Colorado High School Students</brief_title>
  <official_title>The Impact of Sources of Strength, a Primary Prevention Youth Suicide Program, on Sexual Violence Prevention Among Colorado High School Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Texas Tech University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Colorado Department of Public Health and Environment</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Florida</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sources of Strength is an evidence based program for youth suicide that trains student key&#xD;
      leaders to strengthen social connectedness and healthy norms school-wide and is listed on the&#xD;
      National Registry of Evidence Based Programs and Practices (NREPP). This project will expand&#xD;
      the existing evidence base by evaluating Sources of Strength for sexual violence outcomes in&#xD;
      a randomized controlled trial (RCT) in twenty-four high schools.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At present few programs systematically address broader social-ecological factors such as&#xD;
      school-wide norms and youth-adult connectedness that research identifies as major drivers of&#xD;
      sexual violence. To address this gap, this application proposes a large-scale RCT evaluation&#xD;
      of Sources of Strength to evaluate for sexual violence perpetration outcomes. Sources of&#xD;
      Strength is an evidence based program for youth suicide that trains student key leaders to&#xD;
      strengthen social connectedness and healthy norms school-wide and is listed on the National&#xD;
      Registry of Evidence Based Programs and Practices (NREPP). This project will expand the&#xD;
      existing evidence base by evaluating Sources of Strength for sexual violence outcomes, which&#xD;
      has never been done before. Twenty-four high schools will be recruited and stratified (rural&#xD;
      or urban) and randomly assigned to one of two conditions: (a) immediate Sources of Strength&#xD;
      intervention, (b) wait-list for Sources of Strength Implementation after 16 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">September 11, 2019</completion_date>
  <primary_completion_date type="Actual">September 11, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in sexual violence perpetration measured by method of survey</measure>
    <time_frame>Baseline; Month 24</time_frame>
    <description>Sexual violence perpetration will be measured by method of survey as part of the Sources of Strength suicide prevention program</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in suicidal behaviors measured by method of survey</measure>
    <time_frame>Baseline; Month 24</time_frame>
    <description>Suicidal ideation and behaviors will be measured by method of survey as part of the Sources of Strength suicide prevention program</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Suicide</condition>
  <condition>Sexual Violence</condition>
  <arm_group>
    <arm_group_label>Sources of Strength Suicide (SOS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive Sources of Strength Suicide (SOS) Prevention Program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOS Waitlist Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Delayed implementation of Sources of Strength Suicide Prevention Program after 16 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sources of Strength (SOS) Prevention Program</intervention_name>
    <description>Sources of Strength is an evidence based program for youth suicide that trains student key leaders to strengthen social connectedness and healthy norms school-wide and is listed on the National Registry of Evidence Based Programs and Practices (NREPP).</description>
    <arm_group_label>SOS Waitlist Control</arm_group_label>
    <arm_group_label>Sources of Strength Suicide (SOS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  high school student in participating school, parents did not withdraw from study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomei Kuehl, MPA</last_name>
    <role>Study Director</role>
    <affiliation>Colorado Department of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Colorado Department of Public Health and Environment</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03014271
org study id: IRB201702833
secondary id: 2016-U-0436
secondary id: 1U01CE002841-01
secondary id: GRANT12174446
nct id: NCT03014271
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sources of Strength is an evidence based program for youth suicide that trains student key
      leaders to strengthen social connectedness and healthy norms school-wide and is listed on the
      National Registry of Evidence Based Programs and Practices (NREPP). This project will expand
      the existing evidence base by evaluating Sources of Strength for sexual violence outcomes in
      a randomized controlled trial (RCT) in twenty-four high schools.
At present few programs systematically address broader social-ecological factors such as
      school-wide norms and youth-adult connectedness that research identifies as major drivers of
      sexual violence. To address this gap, this application proposes a large-scale RCT evaluation
      of Sources of Strength to evaluate for sexual violence perpetration outcomes. Sources of
      Strength is an evidence based program for youth suicide that trains student key leaders to
      strengthen social connectedness and healthy norms school-wide and is listed on the National
      Registry of Evidence Based Programs and Practices (NREPP). This project will expand the
      existing evidence base by evaluating Sources of Strength for sexual violence outcomes, which
      has never been done before. Twenty-four high schools will be recruited and stratified (rural
      or urban) and randomly assigned to one of two conditions: (a) immediate Sources of Strength
      intervention, (b) wait-list for Sources of Strength Implementation after 16 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in sexual violence perpetration measured by method of survey
time frame: Baseline; Month 24
description: Sexual violence perpetration will be measured by method of survey as part of the Sources of Strength suicide prevention program
measure: Change in suicidal behaviors measured by method of survey
time frame: Baseline; Month 24
description: Suicidal ideation and behaviors will be measured by method of survey as part of the Sources of Strength suicide prevention program
arm group label: Sources of Strength Suicide (SOS)
arm group type: Experimental
description: Receive Sources of Strength Suicide (SOS) Prevention Program
arm group label: SOS Waitlist Control
arm group type: Active Comparator
description: Delayed implementation of Sources of Strength Suicide Prevention Program after 16 months.
intervention type: Behavioral
intervention name: Sources of Strength (SOS) Prevention Program
description: Sources of Strength is an evidence based program for youth suicide that trains student key leaders to strengthen social connectedness and healthy norms school-wide and is listed on the National Registry of Evidence Based Programs and Practices (NREPP).
arm group label: SOS Waitlist Control
arm group label: Sources of Strength Suicide (SOS)
criteria: 
gender: All
minimum age: 13 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tomei Kuehl, MPA
role: Study Director
affiliation: Colorado Department of Public Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Suicide
sharing ipd: No