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

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT03014271
• Collaborator: University of Rochester (Other), Texas Tech University (Other), Colorado Department of Public Health and Environment (Other), Centers for Disease Control and Prevention (U.S. Fed)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 36.3
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Suicide; Sexual Violence	Behavioral: Sources of Strength (SOS) Prevention Program	N/A

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 Design

• Study Type: Interventional
• 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: Sep 1, 2016
• Actual Primary Completion Date: Sep 11, 2019
• Actual Study Completion Date: Sep 11, 2019

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Change in sexual violence perpetration measured by method of survey [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 [Baseline; Month 24]

   Suicidal ideation and behaviors will be measured by method of survey as part of the Sources of Strength suicide prevention program

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 19 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Study Director: Tomei Kuehl, MPA, Colorado Department of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03014271
• Other Study ID Numbers: IRB201702833; 2016-U-0436; 1U01CE002841-01; GRANT12174446
• First Posted: Jan 9, 2017
• Last Update Posted: Oct 3, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Suicide

Study Results

No Results Posted as of Oct 3, 2019