- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02043093
Effectiveness Trial of Youth Suicide Prevention Delivered by Teen Peer Leaders
Effectiveness Trial of Suicide Prevention Delivered by Teen Peer Leaders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Investigators will enroll and conduct this trial with 3-4 separate cohorts of high schools over five years, allowing the logistical load to be evenly distributed throughout the study (total 40 schools). Randomization will occur at the school level since Sources of Strength is a school-wide intervention. In each cohort, schools will be enrolled as pairs from the same regions in New York State or North Dakota, for a total of six pairs per cohort. One school from each pair will be randomly assigned to begin training within a few months (Immediate Intervention) or to a wait-list to receiving training approximately 2 years later (Wait List). By pairing schools from the same region and state, before they are randomly assigned to one of the two study conditions, the design reduces the potential for external events (e.g., suicide of a local celebrity) biasing students' behaviors or self-reports within one of the conditions, which could affect investigators' ability to evaluate intervention impact.
The active intervention period in each cohort will span approximately 16 months to test the impact on the school population of Sources of Strength training and messaging steps over two school years, which is the optimal time-period for this intervention. Schools assigned to the Wait List Condition will receive training and begin program implementation in the fall of the third school year, and investigators will provide those schools with training and technical assistance to complete the intervention over 16 months, fully comparable to the early intervention schools.
To assess outcomes of suicide attempts, hypothesized mechanisms of intervention impact (coping norms and practices, connections with adults and peers), and mental health and behavioral risk factors, investigators will conduct a baseline and 3 repeated surveys of the student population in each school using surveys. The investigators have successfully employed this strategy previously to test Sources of Strength in 12 high schools in New York and North Dakota and attained high rates of participation, commensurate to or higher than other studies evaluating screening or other community suicide prevention strategies. Baseline surveys (B) will be administered to all students in schools in both conditions before the intervention begins in any school. The next survey administrations will occur at the end of the first school year (6 months, T1), the beginning of the next school year (12 months, T2), and end of the second school year (18 months, T3). Investigators will provide full training and support for those cohort 3 control schools to complete their intervention. In addition, social network data (close friend nominations, trusted adults named) will be collected across all schools to determine network mediators of intervention effects.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Rochester, New York, United States, 14642
- University of Rochester
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- currently enrolled high school students
Exclusion Criteria:
- below 7th grade reading level in English
- parent declines permission
Study Plan
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 |
|---|---|
|
No Intervention: Waiting
Surveys are administered to school students and staff, but Sources of Strength program is not implemented until the school year following two years of survey participation
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|
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Experimental: Intervention
School receives Sources of Strength Peer Leader training and implementation for two school years, beginning in fall of enrollment year.
Peer leaders are actively implementing program across two school years.
Students and school staff participate in surveys across the two implementing school years.
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Sources of Strength (http://www.sourcesofstrength.com/) has three phases:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Suicide Attempts
Time Frame: change from baseline to 18 months
|
Item on suicide attempts from the Youth Risk Behavior Survey: "During the past 12 months, how many times did you actually attempt suicide?"
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change from baseline to 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Help Seeking Acceptability at School
Time Frame: change from baseline to 18 months
|
Positive intentions and norms about seeking help for distress from an adult at school
|
change from baseline to 18 months
|
|
Change in Adult Help for Suicidal Youth
Time Frame: change from baseline to 18 months
|
Positive perceptions that adults at school are available to help suicidal friends
|
change from baseline to 18 months
|
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Change in Reject Codes of Silence
Time Frame: change from baseline to 18 months
|
Intentions to get help for suicidal friends and resist requests for secrecy
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change from baseline to 18 months
|
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Change in number of Named Trusted Adults
Time Frame: change from baseline to 18 months
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Number of adults at the school that students went to for help with a personal problem or to help a friend.
|
change from baseline to 18 months
|
|
Change in proportion of suicidal students who name adult who has helped them
Time Frame: change from baseline to 18 months
|
Measure asks students to name up to 3 adults who have helped them with a personal problem or to get help for a friend.
Investigators will select students who have reported suicidal behavior and examine change in number of adults named.
|
change from baseline to 18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter A Wyman, PhD, University of Rochester
Publications and helpful links
General Publications
- Schmeelk-Cone K, Pisani AR, Petrova M, Wyman PA. Three scales assessing high school students' attitudes and perceived norms about seeking adult help for distress and suicide concerns. Suicide Life Threat Behav. 2012 Apr;42(2):157-72. doi: 10.1111/j.1943-278X.2011.00079.x. Epub 2012 Feb 10.
- Wyman PA, Brown CH, LoMurray M, Schmeelk-Cone K, Petrova M, Yu Q, Walsh E, Tu X, Wang W. An outcome evaluation of the Sources of Strength suicide prevention program delivered by adolescent peer leaders in high schools. Am J Public Health. 2010 Sep;100(9):1653-61. doi: 10.2105/AJPH.2009.190025. Epub 2010 Jul 15.
- Pisani AR, Schmeelk-Cone K, Gunzler D, Petrova M, Goldston DB, Tu X, Wyman PA. Associations between suicidal high school students' help-seeking and their attitudes and perceptions of social environment. J Youth Adolesc. 2012 Oct;41(10):1312-24. doi: 10.1007/s10964-012-9766-7. Epub 2012 May 6.
- Brown CH, Wyman PA, Guo J, Pena J. Dynamic wait-listed designs for randomized trials: new designs for prevention of youth suicide. Clin Trials. 2006;3(3):259-71. doi: 10.1191/1740774506cn152oa.
- Pisani AR, Wyman PA, Petrova M, Schmeelk-Cone K, Goldston DB, Xia Y, Gould MS. Emotion regulation difficulties, youth-adult relationships, and suicide attempts among high school students in underserved communities. J Youth Adolesc. 2013 Jun;42(6):807-20. doi: 10.1007/s10964-012-9884-2. Epub 2012 Dec 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01MH091452 (U.S. NIH Grant/Contract)
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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