Clinical trial NCT04565951: Increasing Help-Seeking Behavior Among Transitioning Veterans at Risk for Suicide With Online Gatekeeper Training
Official title: Increasing Help-Seeking Behavior Among Transitioning Veterans at Risk for Suicide With Online Gatekeeper Training: A Pilot Study of PsychArmor S.A.V.E.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide Prevention
Keywords: suicide
suicide prevention
mental health
veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Canandaigua VA Medical Center
name: PsychArmor Institute
First posted: 2020-09-28
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to either the intervention or the control group. Block-randomization schemes using random block sizes to assign the two study arms will be created in R using the blockrand package before study start and pre-loaded into survey software. The intervention, called VA S.A.V.E., is an online, video-based training tailored to veterans and their close supports. The control group will consist of a "sham" training - a different online, video-based training course developed by the PsychArmor Institute for military service members, veterans, and their loved ones. Topics in this "sham" training may include information relevant to transitioning veterans and their loved ones, such as preparing finances, networking, searching for a job, and using educational benefits. The length of the training will be matched to the intervention (24 minutes) and the "sham" training will also contain other design features similar to the intervention (e.g., motion graphics).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the feasibility and acceptability of a gatekeeper training called VA S.A.V.E. which was developed through a partnership between the VA and the PsychArmor Training Institute. Gatekeeper training teaches "gatekeepers" skills in how to identify a person with suicide risk, inquire about suicidal thoughts, and help make a connection to professional treatment. VA S.A.V.E. is a brief, novel online gatekeeper training that was created and designed specifically for Veterans and their family and friends. In this study, the investigators will recruit Veterans who have recently transitioned out of the military, as well as their family and friends. Participants in the study will be asked to complete a survey, watch the VA S.A.V.E. training, and complete several follow-up surveys over six months. A small subset of participants will also be invited to participate in an interview.

Detailed description: Background: Suicide is an urgent public health crisis, and transitioning Veterans (those who have recently separated from the military) are a high-risk group for suicide. A key component to advancing suicide prevention efforts among at-risk Veterans is to address low levels of help-seeking and engagement in treatment, including Veterans Health Administration (VHA) care. Veterans are most likely to disclose suicidal thoughts to their close supports-family members, friends, and their peers. However, Veterans and their close supports rarely receive training in how to help a peer at risk of suicide, despite strong interest in such training. Gatekeeper training is a key strategy with potential to help address these challenges. Gatekeeper training teaches "gatekeepers" skills in how to identify a Veteran with suicide risk, inquire about suicidal thoughts, and help make a connection to professional treatment; it may benefit the trainee's own mental health too. VA S.A.V.E., developed through a partnership between the VA and the PsychArmor Training Institute, is a brief, novel online gatekeeper training designed for Veterans and their close supports.

Significance/Impact: This project focuses on VA's topic clinical priority, suicide prevention. The 2019 VA and Department of Defense Clinical Practice Guidelines also identified gatekeeper training as an important research gap and priority for future research. This research design addresses three separate goals and objectives contained in VA's National Strategy for Preventing Veteran Suicide, including involvement of Veterans' close supports.

Innovation: This proposal employs the novel approach of recruiting Veterans and their close supports through online social media advertisements, allowing for broad outreach, suicide prevention targeting Veterans outside the VA network, and the potential to test the effectiveness of gatekeeper training on a large scale. Online gatekeeper trainings are highly scalable public health strategies with the potential to diffuse through online social networks.

Specific Aims: The primary objective is to conduct a pilot randomized controlled trial (RCT) to evaluate the feasibility and acceptability of the online gatekeeper training VA S.A.V.E. To reach this objective the investigators will achieve these aims: 1) Determine the feasibility of recruiting participants via social media, engaging them to participate in an online gatekeeper training program, and retaining them in an online intervention study; and 2) Determine the acceptability of VA S.A.V.E. in a pilot RCT, and evaluate measures for use in a future larger-scale RCT.

Methodology: This is a two-arm pilot randomized clinical trial involving 200 participants. Participants will be recruited through social media advertisements targeting transitioning Veterans and their close supports (family and friends). Participants will be randomized to take the VA S.A.V.E. gatekeeper training or a "sham" control training and followed for 6 months. Mixed quantitative and qualitative methods will be used to assess outcomes on feasibility and acceptability. Additional data collection and analysis of measures related to suicide prevention, such as gatekeeper behaviors, knowledge, stigma, self-efficacy, and social norms measures will help prepare for a larger-scale RCT.

Implementation/Next Steps: By using an extremely scalable intervention and building off existing VA practices and partnerships, this project will be very well-positioned for further evaluation and implementation into VA practice if found to be effective. It is freely available online, making it highly amenable to being rapidly taken to scale. Results of this project will inform future efforts to disseminate and/or revise VA S.A.V.E.

Eligibility criteria: Inclusion Criteria:

* A veteran who has served on active duty in the U.S. Armed Forces within the prior 12 months, OR a person who feels "close to" a veteran; AND
* Social contact with a veteran at least weekly

Exclusion Criteria:

* Lack a U.S. phone number, email, or computer access; OR
* Not fluent in English; OR
* Have previously taken or intend to take VA S.A.V.E. training; OR
* Duplicate study entry or misrepresentation of veteran status.

Primary outcomes:
measure: Recruitment
timeFrame: baseline (T=0)
measure: Survey Completion Rates
timeFrame: 1-month follow-up, 2-month follow-up, 3-month follow-up, 4-month follow-up, 5-month follow-up, 6-month follow-up
Secondary outcomes:
measure: Training Completion
timeFrame: Post-training (immediately after), approximately 1 hour
measure: Satisfaction With the Intervention Video
timeFrame: Post-training (immediately after), approximately 1 hour
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Alan R. Teo, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teo AR, Call AA, Hooker ER, Fong C, Karras E, Dobscha SK. Feasibility of recruitment and retention in a remote trial of gatekeeper training for close supports of military veterans: Mixed methods study. Contemp Clin Trials Commun. 2022 Sep 5;30:100993. doi: 10.1016/j.conctc.2022.100993. eCollection 2022 Dec.