NCT04021758

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,055

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

2.2 years

First QC Date

May 2, 2019

Last Update Submit

October 5, 2022

Conditions

Keywords

Suicide preventionPeer mentoring

Outcome Measures

Primary Outcomes (3)

  • Change in number of suicide deaths from baseline

    Number of suicide deaths will be collected from Department of Defense Suicide Event Report data.

    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.

  • Change in suicidal behaviors from baseline

    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.

    Participants will complete self-report assessments at baseline and every four months during follow-up for a total of 20 months.

  • Change in suicide ideation from baseline

    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.

    . Participants will complete self-report assessments at baseline and every four months during follow-up for a total of 20 months.

Study Arms (2)

Peer to peer program intervention

EXPERIMENTAL

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

Wait list

NO INTERVENTION

Interventions

Peer to peer suicide prevention program aimed at reducing suicide in a military population.

Also known as: Airman's Edge
Peer to peer program intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older; and
  • able to understand and speak the English language.

You may not qualify if:

  • an inability to understand and speak the English language and
  • an inability to complete the informed consent process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Whiteman Air Force Base

Whiteman Air Force Base, Missouri, 65305, United States

Location

Related Publications (4)

  • 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

    BACKGROUND
  • 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: 28967323BACKGROUND
  • 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: 28142085BACKGROUND
  • 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: 24712868BACKGROUND

Related Links

MeSH Terms

Conditions

SuicideSuicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Craig J Bryan, PsyD

    The University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 2, 2019

First Posted

July 16, 2019

Study Start

January 1, 2020

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

October 6, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations