- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03014271
Primary Prevention Youth Suicide Trial in Colorado High Schools Prevention Among Colorado High School Students
March 11, 2024 updated by: University of Florida
The Impact of Sources of Strength, a Primary Prevention Youth Suicide Program, on Sexual Violence Prevention Among Colorado High School Students
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80246
- Colorado Department of Public Health and Environment
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- high school student in participating school, parents did not withdraw from study
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sources of Strength Suicide (SOS)
Receive Sources of Strength Suicide (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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline; Month 24
|
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
|
Baseline; Month 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Tomei Kuehl, MPA, Colorado Department of Public Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2017
Primary Completion (Actual)
September 11, 2019
Study Completion (Actual)
September 11, 2019
Study Registration Dates
First Submitted
January 5, 2017
First Submitted That Met QC Criteria
January 6, 2017
First Posted (Estimated)
January 9, 2017
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 11, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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