SuicideNCT03014271
Primary Prevention Youth Suicide Trial in Colorado High Schools Prevention Among Colorado High School Students
A study testing Sources of Strength (SOS) Prevention Program in people with Suicide and Sexual Violence, run by University of Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide, Sexual Violence
- What is being tested?
- Sources of Strength (SOS) Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2017to 11 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- high school student in participating school, parents did not withdraw from study
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado Department of Public Health and Environment
Denver, Colorado, 80246
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide, Sexual Violence
- Being tested
- Sources of Strength (SOS) Prevention Program
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sources of Strength (SOS) Prevention ProgramBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Sources of Strength Suicide (SOS) | Experimental | Receive Sources of Strength Suicide (SOS) Prevention Program Receives: Behavioral: Sources of Strength (SOS) Prevention Program |
| SOS Waitlist Control | Active comparator | Delayed implementation of Sources of Strength Suicide Prevention Program after 16 months. Receives: Behavioral: Sources of Strength (SOS) Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline; Month 24
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
Measured: Baseline; Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start21 Aug 2017
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester, Texas Tech University, Colorado Department of Public Health and Environment, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Tomei Kuehl, MPA, Study director, Colorado Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014271
- Sponsor's protocol ID
- IRB201702833
- Other IDs
- 2016-U-0436, 1U01CE002841-01, GRANT12174446
- Status last verified
- Mar 2024
- First submitted
- 5 Jan 2017
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wyman PA, Cero IJ, Espelage DL, Reif T, Mintz S, LoMurray S, Nickodem K, Schmeelk-Cone KH, Delgado A. RCT of Sources of Strength Testing Impact on Suicide Attempts and Tests of Moderation by Sexual Violence Victimization and Perpetration. Am J Prev Med. 2025 Mar;68(3):465-474. doi: 10.1016/j.amepre.2024.11.008. Epub 2024 Nov 29.
PubMed 39617103
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sources of Strength, a Primary Prevention Youth Suicide Program, on Sexual Violence Prevention Among Colorado High School Students
- ClinicalTrials.gov ID
- NCT03014271
- Acronym / sponsor ID
- IRB201702833
- Conditions
- Suicide, Sexual Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of Rochester, Texas Tech University, Colorado Department of Public Health and Environment, Centers for Disease Control and Prevention
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sources of Strength Suicide (SOS) | Experimental | Behavioral: Sources of Strength (SOS) Prevention ProgramReceive Sources of Strength Suicide (SOS) Prevention Program |
| SOS Waitlist Control | Active comparator | Behavioral: Sources of Strength (SOS) Prevention ProgramDelayed implementation of Sources of Strength Suicide Prevention Program after 16 months. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- high school student in participating school, parents did not withdraw from study
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sources of Strength (SOS) Prevention ProgramSources 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). | Behavioural | SOS Waitlist Control, Sources of Strength Suicide (SOS) |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 39617103Wyman PA, Cero IJ, Espelage DL, Reif T, Mintz S, LoMurray S, Nickodem K, Schmeelk-Cone KH, Delgado A. RCT of Sources of Strength Testing Impact on Suicide Attempts and Tests of Moderation by Sexual Violence Victimization and Perpetration. Am J Prev Med. 2025 Mar;68(3):465-474. doi: 10.1016/j.amepre.2024.11.008. Epub 2024 Nov 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomei Kuehl, MPA study director
Colorado Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sources of Strength (SOS) Prevention Program in people with Suicide and Sexual Violence, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sexual violence perpetration measured by method of survey (time frame: Baseline; Month 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03014271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.