Viewing Study NCT02043093



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Last Modification Date: 2024-10-26 @ 11:18 AM
Study NCT ID: NCT02043093
Status: COMPLETED
Last Update Posted: 2017-01-05
First Post: 2014-01-15

Brief Title: Effectiveness Trial of Youth Suicide Prevention Delivered by Teen Peer Leaders
Sponsor: University of Rochester
Organization: University of Rochester

Study Overview

Official Title: Effectiveness Trial of Suicide Prevention Delivered by Teen Peer Leaders
Status: COMPLETED
Status Verified Date: 2017-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
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 eg 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
5R01MH091452 NIH None httpsreporternihgovquickSearch5R01MH091452