Effectiveness Trial of Youth Suicide Prevention Delivered by Teen Peer Leaders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02043093|
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : January 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Suicide Prevention||Behavioral: Sources of Strength||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||17603 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness Trial of Suicide Prevention Delivered by Teen Peer Leaders|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2016|
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
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.
Behavioral: Sources of Strength
Sources of Strength (http://www.sourcesofstrength.com/) has three phases:
- 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?"
- 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 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 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
- Change in number of Named Trusted Adults [ Time Frame: change from baseline to 18 months ]Number of adults at the school that students went to for help with a personal problem or to help a friend.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043093
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Peter A Wyman, PhD||University of Rochester|