跳至主要内容
临床试验/NCT04021758
NCT04021758已完成不适用

Peer to Peer Programs for Military Suicide Prevention

University of Utah2 个研究点 分布在 1 个国家目标入组 2,055 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,055
试验地点
2
主要终点
Change in suicidal behaviors from baseline

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change in suicidal behaviors from baseline

时间窗: 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 number of suicide deaths from baseline

时间窗: 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 suicide ideation from baseline

时间窗: . 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Craig Bryan

Associate Professor

University of Utah

研究点 (2)

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