Clinical trial NCT04021758: Peer to Peer Programs for Military Suicide Prevention
Official title: Peer to Peer Programs for Military Suicide Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Suicide prevention
Peer mentoring
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Xcelerate Innovations
First posted: 2019-07-16
Enrollment: 2055
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Change in number of suicide deaths from baseline
timeFrame: 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.
measure: Change in suicidal behaviors from baseline
timeFrame: Participants will complete self-report assessments at baseline and every four months during follow-up for a total of 20 months.
measure: Change in suicide ideation from baseline
timeFrame: . Participants will complete self-report assessments at baseline and every four months during follow-up for a total of 20 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Base De La Fuerza Aérea Whiteman
country: United States
facility: Whiteman Air Force Base
state: Missouri
Study officials:
affiliation: The University of Utah
name: Craig J Bryan, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
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
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.
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.
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.