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Primary Prevention Youth Suicide Trial in Colorado High Schools Prevention Among Colorado High School Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014271
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
University of Rochester
Texas Tech University
Colorado Department of Public Health and Environment
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Suicide Sexual Violence Behavioral: Sources of Strength (SOS) Prevention Program Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Sources of Strength, a Primary Prevention Youth Suicide Program, on Sexual Violence Prevention Among Colorado High School Students
Study Start Date : September 2016
Actual Primary Completion Date : September 11, 2019
Actual Study Completion Date : September 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Sources of Strength Suicide (SOS)
Receive Sources of Strength Suicide (SOS) Prevention Program
Behavioral: Sources of Strength (SOS) Prevention Program
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).

Active Comparator: SOS Waitlist Control
Delayed implementation of Sources of Strength Suicide Prevention Program after 16 months.
Behavioral: Sources of Strength (SOS) Prevention Program
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).




Primary Outcome Measures :
  1. Change in sexual violence perpetration measured by method of survey [ Time Frame: Baseline; Month 24 ]
    Sexual violence perpetration will be measured by method of survey as part of the Sources of Strength suicide prevention program

  2. Change in suicidal behaviors measured by method of survey [ Time Frame: Baseline; Month 24 ]
    Suicidal ideation and behaviors will be measured by method of survey as part of the Sources of Strength suicide prevention program



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • high school student in participating school, parents did not withdraw from study

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014271


Locations
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United States, Colorado
Colorado Department of Public Health and Environment
Denver, Colorado, United States, 80246
Sponsors and Collaborators
University of Florida
University of Rochester
Texas Tech University
Colorado Department of Public Health and Environment
Centers for Disease Control and Prevention
Investigators
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Study Director: Tomei Kuehl, MPA Colorado Department of Public Health
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03014271    
Other Study ID Numbers: IRB201702833
2016-U-0436 ( Other Identifier: IRB-02 )
1U01CE002841-01 ( U.S. NIH Grant/Contract )
GRANT12174446 ( Other Grant/Funding Number: Centers for Disease Control )
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms