Primary Prevention Youth Suicide Trial in Colorado High Schools Prevention Among Colorado High School Students
Primary Purpose
Suicide, Sexual Violence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sources of Strength (SOS) Prevention Program
Sponsored by
About this trial
This is an interventional prevention trial for Suicide
Eligibility Criteria
Inclusion Criteria:
- high school student in participating school, parents did not withdraw from study
Exclusion Criteria:
- none
Sites / Locations
- Colorado Department of Public Health and Environment
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sources of Strength Suicide (SOS)
SOS Waitlist Control
Arm Description
Receive Sources of Strength Suicide (SOS) Prevention Program
Delayed implementation of Sources of Strength Suicide Prevention Program after 16 months.
Outcomes
Primary Outcome Measures
Change in sexual violence perpetration measured by method of survey
Sexual violence perpetration will be measured by method of survey as part of the Sources of Strength suicide prevention program
Change in suicidal behaviors measured by method of survey
Suicidal ideation and behaviors will be measured by method of survey as part of the Sources of Strength suicide prevention program
Secondary Outcome Measures
Full Information
NCT ID
NCT03014271
First Posted
January 5, 2017
Last Updated
October 2, 2019
Sponsor
University of Florida
Collaborators
University of Rochester, Texas Tech University, Colorado Department of Public Health and Environment, Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT03014271
Brief Title
Primary Prevention Youth Suicide Trial in Colorado High Schools Prevention Among Colorado High School Students
Official Title
The Impact of Sources of Strength, a Primary Prevention Youth Suicide Program, on Sexual Violence Prevention Among Colorado High School Students
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 11, 2019 (Actual)
Study Completion Date
September 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
University of Rochester, Texas Tech University, Colorado Department of Public Health and Environment, Centers for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Sexual Violence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sources of Strength Suicide (SOS)
Arm Type
Experimental
Arm Description
Receive Sources of Strength Suicide (SOS) Prevention Program
Arm Title
SOS Waitlist Control
Arm Type
Active Comparator
Arm Description
Delayed implementation of Sources of Strength Suicide Prevention Program after 16 months.
Intervention Type
Behavioral
Intervention Name(s)
Sources of Strength (SOS) Prevention Program
Intervention 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).
Primary Outcome Measure Information:
Title
Change in sexual violence perpetration measured by method of survey
Description
Sexual violence perpetration will be measured by method of survey as part of the Sources of Strength suicide prevention program
Time Frame
Baseline; Month 24
Title
Change in suicidal behaviors measured by method of survey
Description
Suicidal ideation and behaviors will be measured by method of survey as part of the Sources of Strength suicide prevention program
Time Frame
Baseline; Month 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
high school student in participating school, parents did not withdraw from study
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomei Kuehl, MPA
Organizational Affiliation
Colorado Department of Public Health
Official's Role
Study Director
Facility Information:
Facility Name
Colorado Department of Public Health and Environment
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Primary Prevention Youth Suicide Trial in Colorado High Schools Prevention Among Colorado High School Students
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