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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02043093
Other study ID # 5R01MH091452
Secondary ID 5R01MH091452
Status Completed
Phase N/A
First received January 15, 2014
Last updated January 4, 2017
Start date August 2010
Est. completion date June 2016

Study information

Verified date January 2017
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the impact of the school-based Sources of Strength program in reducing suicidal behaviors in the population of high school students and determine how the program works (mechanisms of change). Sources of Strength trains diverse high school students as Peer Leaders, who conduct school-wide prevention messaging activities with ongoing adult mentoring designed to increase positive coping norms and practices, help-seeking and increase youth-adult connections. Sources of Strength is expected to enhance school coping practices, increase help-seeking among distressed and suicidal youth, and reduce the number of students in the population who attempt suicide. A total of 40 high schools in primarily rural and micropolitan regions of New York State and North Dakota will participate in this study that uses a randomized wait-listed design.


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.


Recruitment information / eligibility

Status Completed
Enrollment 17603
Est. completion date June 2016
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 20 Years
Eligibility Inclusion Criteria:

- currently enrolled high school students

Exclusion Criteria:

- below 7th grade reading level in English

- parent declines permission

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Sources of Strength
Sources of Strength (http://www.sourcesofstrength.com/) has three phases: Introduction to school and community partners. Staff advisors for the program are identified and trained. A standard process is used for nominating student peer leaders, who are trained through a 4-hour interactive workshop. A major focus is on increasing knowledge of 'sources of strength' and skills for increasing use of those resources for themselves and other students. Peer Leaders plan and conduct messaging with Adult Advisor mentoring. A school-wide messaging phase involves presentations; media campaigns through posters, public service announcements, videos.

Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (5)

Lead Sponsor Collaborator
University of Rochester Columbia University, National Institute of Mental Health (NIMH), Northwestern University, University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (5)

Brown CH, Wyman PA, Guo J, Peña J. Dynamic wait-listed designs for randomized trials: new designs for prevention of youth suicide. Clin Trials. 2006;3(3):259-71. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Suicide Attempts Item on suicide attempts from the Youth Risk Behavior Survey: "During the past 12 months, how many times did you actually attempt suicide?" change from baseline to 18 months Yes
Secondary Change in Help Seeking Acceptability at School Positive intentions and norms about seeking help for distress from an adult at school change from baseline to 18 months No
Secondary Change in Adult Help for Suicidal Youth Positive perceptions that adults at school are available to help suicidal friends change from baseline to 18 months No
Secondary Change in Reject Codes of Silence Intentions to get help for suicidal friends and resist requests for secrecy change from baseline to 18 months No
Secondary Change in number of Named Trusted Adults 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 No
Secondary Change in proportion of suicidal students who name adult who has helped them 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 No
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