- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04021758
Peer to Peer Programs for Military Suicide Prevention (P2P)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Missouri
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Base De La Fuerza Aérea Whiteman, Missouri, United States, 65305
- Whiteman Air Force Base
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or older; and
- able to understand and speak the English language.
Exclusion Criteria:
- an inability to understand and speak the English language and
- an inability to complete the informed consent process.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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NO_INTERVENTION: Wait list
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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).
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Peer to peer suicide prevention program aimed at reducing suicide in a military population.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Number of suicide deaths will be collected from Department of Defense Suicide Event Report data.
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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.
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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.
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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.
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Participants will complete self-report assessments at baseline and every four months during follow-up for a total of 20 months.
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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.
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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.
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. Participants will complete self-report assessments at baseline and every four months during follow-up for a total of 20 months.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Craig J Bryan, PsyD, The University of Utah
Publications and helpful links
General Publications
- Bryan CJ, Mintz J, Clemans TA, Leeson B, Burch TS, Williams SR, Maney E, Rudd MD. Effect of crisis response planning vs. contracts for safety on suicide risk in U.S. Army Soldiers: A randomized clinical trial. J Affect Disord. 2017 Apr 1;212:64-72. doi: 10.1016/j.jad.2017.01.028. Epub 2017 Jan 23.
- Bryan, C. J., & Morrow, C. E. (2011). Circumventing mental health stigma by embracing the warrior culture: Lessons learned from the Defender's Edge program. Professional Psychology: Research and Practice, 42(1), 16-23. https://doi.org/10.1037/a0022290
- Bryan CJ, Mintz J, Clemans TA, Burch TS, Leeson B, Williams S, Rudd MD. Effect of Crisis Response Planning on Patient Mood and Clinician Decision Making: A Clinical Trial With Suicidal U.S. Soldiers. Psychiatr Serv. 2018 Jan 1;69(1):108-111. doi: 10.1176/appi.ps.201700157. Epub 2017 Oct 2.
- Bryan CJ, Andreski SR, McNaughton-Cassill M, Osman A. Agency is associated with decreased emotional distress and suicidal ideation in military personnel. Arch Suicide Res. 2014;18(3):241-50. doi: 10.1080/13811118.2013.824836.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT170195
- W81XWH-18-2-0064 (OTHER_GRANT: Congressionally Directed Medical Research Programs, USAMRMC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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