Effectiveness Trial of Youth Suicide Prevention Delivered by Teen Peer Leaders

NCT ID: NCT02043093

Last Updated: 2017-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17603 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Suicide Prevention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Sources of Strength

Intervention Type BEHAVIORAL

Sources of Strength (http://www.sourcesofstrength.com/) has three phases:

1. Introduction to school and community partners. Staff advisors for the program are identified and trained.
2. 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.
3. 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sources of Strength

Sources of Strength (http://www.sourcesofstrength.com/) has three phases:

1. Introduction to school and community partners. Staff advisors for the program are identified and trained.
2. 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.
3. 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* currently enrolled high school students

Exclusion Criteria

* below 7th grade reading level in English
* parent declines permission
Minimum Eligible Age

13 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter Wyman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter A Wyman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Rochester

Rochester, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20634440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22324773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22562217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16895043 (View on PubMed)

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.

Reference Type RESULT
PMID: 23666604 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5R01MH091452

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01MH091452

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.