Base De La Fuerza Aérea Whiteman, Missouri 65305

  • Suicide

Purpose:

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 summary:

Suicides among military personnel doubled from 2001 to 2015 and have remained elevated. Although new treatments and interventions have been shown to reduce the occurrence of suicidal behavior, they are predominantly available only in mental health clinics. Data indicates that the large majority of military personnel who die by suicide do not access mental healthcare services in the months preceding their deaths. New strategies that are based on these empirically-supported interventions but can be delivered outside the mental healthcare system, thereby reaching a larger proportion of the military community, are therefore needed. Peer to peer (P2P) support programs hold promise as a method for achieving these aims, but the evidence supporting this intervention model remains limited or, in the case of suicide prevention, absent. In light of this gap, the proposed project aims to test the efficacy of a P2P program for the reduction of suicidal behaviors among military personnel. The proposed P2P program, called Airman's Edge, is a hybrid model that includes both group-based peer educator and individual-based peer support components; these P2P program models have demonstrated the strongest outcomes with respect to changing attitudes, perspectives, and behaviors, all of which are key targets for reducing suicidal thoughts and behaviors. The Airman's Edge program is comprised of several skills-based strategies that have been shown to directly reduce suicidal thoughts and behaviors (i.e., sleep habits, firearm safety procedures, crisis response planning), and targets population-level contextual variables known to reduce suicide risk (i.e., purpose and meaning in life, social support). The mechanisms by which these strategies reduce suicidal behavior align with an empirically-supported conceptual model, the suicidal mode, which has guided recent advances in military suicide prevention. The delivery platform for the skills-based strategies employed in the Airman's Edge program have demonstrated very good acceptability and feasibility when used with military personnel.


Criteria:

Inclusion Criteria: 1. 18 years of age or older; and 2. able to understand and speak the English language. Exclusion Criteria: 1. an inability to understand and speak the English language and 2. an inability to complete the informed consent process.


Study is Available At:


Original ID:

PT170195


NCT ID:

NCT04021758


Secondary ID:

W81XWH-18-2-0064


Study Acronym:

P2P


Brief Title:

Peer to Peer Programs for Military Suicide Prevention


Official Title:

Peer to Peer Programs for Military Suicide Prevention


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Utah


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

1600


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Craig J Bryan, PsyD
Principal Investigator
The University of Utah
Primary Contact:Justin C Baker, PhD
801-587-7978
justin.c.baker@utah.edu
Backup Contact:Craig J Bryan, PsyD
801-587-7978
craig.bryan@utah.edu

Study Dates

Start Date:January 1, 2020
Completion Date:November 1, 2021
Completion Type:Anticipated
Primary Completion Date:February 1, 2021
Primary Completion Type:Anticipated
Verification Date:March 2020
Last Changed Date:March 4, 2020
First Received Date:May 2, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in suicide ideation from baseline
Time Frame:. Participants will complete self-report assessments at baseline and every four months during follow
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Change in suicidal behaviors from baseline
Time Frame:Participants will complete self-report assessments at baseline and every four months during follow-u
Safety Issues:False
Description: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 recommende
Outcome Type:Primary Outcome
Measure: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 stud
Safety Issues:False
Description:Number of suicide deaths will be collected from Department of Defense Suicide Event Report data.

Study Interventions

Intervention Type:Behavioral
Name:Peer to peer program intervention
Description:Peer to peer suicide prevention program aimed at reducing suicide in a military population.
Arm Name:Peer to peer program intervention
Other Name:Airman's Edge

Study Arms

Study Arm Type:No Intervention
Arm Name:Wait list
Study Arm Type:Experimental
Arm Name:Peer to peer program intervention
Description: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).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Utah
Agency Class:Other
Agency Type:Collaborator
Agency Name:Xcelerate Innovations

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:24712868
Reference Type:Reference
Citation: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.
PMID:28142085
Reference Type:Reference
Citation: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.
PMID:28967323
Reference Type:Reference
Citation: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

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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