Peer to Peer Programs for Military Suicide Prevention (P2P)
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|ClinicalTrials.gov Identifier: NCT04021758|
Recruitment Status : Not yet recruiting
First Posted : July 16, 2019
Last Update Posted : July 16, 2019
In the present project the investigators propose to test the efficacy of a peer to peer program entitled Airman's Edge. The Airman's Edge program plans to utilize peer mentors that will be trained in specialized skills designed to impact suicide risk at multiple levels of the military community without creating "extra duties" that increase workload and interfere with mission demands. Peer mentors will introduce primary prevention strategies to their units that target broad-based risk factors across the entire population (i.e., sleep disturbance, social support, meaning in life, firearm safety) with secondary prevention strategies that target individual-level risk factors (i.e., crisis response planning, firearm safety counseling). Peer mentors will complete a structured training process using existing curriculum and procedures that have been tested and refined within military groups. Peers mentors will also participate in monthly consultation calls with the investigative team to receive ongoing support, share resources and lessons learned, and address challenges and barriers to program implementation.
The purpose of the Airman's Edge peer to peer program is to influence indicators of suicide risk among military personnel at two levels, group and individual, consistent with the program's hybrid design that combines group-based education and individual-level suicide prevention skills training. The hypotheses are therefore designed to examine outcomes and effects at multiple levels of the community, which could inform subsequent implementation and translational efforts. The following aims are proposed:
Aim 1: To test the efficacy of a peer to peer program for the reduction of suicidal behavior among military personnel.
Aim 2: To identify moderators and mediators of the peer to peer program's effects on suicidal behavior.
|Condition or disease||Intervention/treatment||Phase|
|Suicide||Behavioral: Peer to peer program intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1600 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
The study design entails a dynamic wait list design in which participants are randomly assigned to either the Peer-to-Peer (P2P) program or a wait list control condition. Randomization will be conducted at the squadron level using a computerized randomization algorithm.
The proposed dynamic wait list design differs primarily from the traditional wait list designs with respect to timing of intervention. In the traditional wait list design, half of the squadrons (i.e., N/2) would be randomized to implement the P2P program early in the study and the remaining half would implement the P2P program later in the study. By contrast, the dynamic wait list randomizes the timing of the intervention over the entire course of the study period by first dividing the overall study period into m equal time blocks, and then randomizing N/m squadrons to receive the P2P program during each time block.
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Data analyses will be conducted by a quantitative psychology postdoctoral fellow under the supervision of Dr. Brian Baucom, PhD, at The University of Utah, and Kent Corso, PsyD, BCBA-D, at Xcelerate Innovations. Dr. Baucom serves on the University of Utah's Department of Psychology's Statistical Consulting Service, and has prior experience with clinical trial methodology and military research. Dr. Corso is a certified behavior analyst with extensive experience using single case design methodology and applying this approach to military settings. None of the data analysts will be involved in data collection procedures, and will remain therefore blind to treatment assignment. Prior to statistical analyses, data will be screened to identify distributional properties.|
|Official Title:||Peer to Peer Programs for Military Suicide Prevention|
|Estimated Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||November 1, 2021|
Experimental: Peer to peer program intervention
The experimental condition for the proposed project is the Airman's Edge program, a peer to peer program in which peer mentors will be trained to provide a series of interventions aimed at reducing risk for suicidal behaviors both directly and indirectly through the targeting of emotion dysregulation, cognitive rigidity, and contextual risk factors (e.g., insomnia, meaning in life, social support, firearm availability).
Behavioral: Peer to peer program intervention
Peer to peer suicide prevention program aimed at reducing suicide in a military population.
Other Name: Airman's Edge
|No Intervention: Wait list|
- Change in number of suicide deaths from baseline [ Time Frame: Administrative data will be requested at baseline for the five years preceding the start of the study, and will be requested on a quarterly basis through study completion, an average of 20 months. ]Number of suicide deaths will be collected from Department of Defense Suicide Event Report data.
- Change in suicidal behaviors from baseline [ Time Frame: Participants will complete self-report assessments at baseline and every four months during follow-up for a total of 20 months. ]Include suicide attempts, aborted suicide attempts, and interrupted suicide attempts. Will be assessed using the self-report version of the Self-Injurious Thoughts and Behaviors Interview (SITBI; Nock et al., 2007). The SITBI is a PhenX Toolkit recommended common data element.
- Change in suicide ideation from baseline [ Time Frame: . Participants will complete self-report assessments at baseline and every four months during follow-up for a total of 20 months. ]Suicide ideation will be assessed using the self-report version of the Self-Injurious Thoughts and Behaviors Interview (SITBI; Nock et al., 2007). The SITBI is a PhenX Toolkit recommended common data element.
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): NCT04021758
|Contact: Justin C Baker, PhDemail@example.com|
|Contact: Craig J Bryan, PsyDfirstname.lastname@example.org|
|United States, Missouri|
|Whiteman Air Force Base||Not yet recruiting|
|Base De La Fuerza Aérea Whiteman, Missouri, United States, 65305|
|Contact: Christopher J Button, PhD 660-687-4341 email@example.com|
|Principal Investigator:||Craig J Bryan, PsyD||The University of Utah|