- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04565951
Increasing Help-Seeking Behavior Among Transitioning Veterans at Risk for Suicide With Online Gatekeeper Training
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Oregon
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Portland, Oregon, United States, 97239
- VA Portland Health Care System, Portland, OR
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment arm
Participants in this arm will receive the intervention, VA S.A.V.E.
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The intervention is called VA S.A.V.E.
It is an online video-based training tailored to veterans and their close supports.
It is free, brief (24 minutes), and includes three scripted role plays.
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Sham Comparator: Sham arm
Participants in this arm will receive a "sham" training, not the intervention, consisting of information unrelated to suicide prevention but relevant to transitioning veterans and their loved ones.
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A "sham" training consisting of information unrelated to suicide prevention but relevant to transitioning veterans and their loved ones.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment
Time Frame: baseline (T=0)
|
Number enrolled; proportion of eligible who enroll
|
baseline (T=0)
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Survey Completion Rates
Time Frame: 1-month follow-up, 2-month follow-up, 3-month follow-up, 4-month follow-up, 5-month follow-up, 6-month follow-up
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Survey completion at each survey timepoint
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1-month follow-up, 2-month follow-up, 3-month follow-up, 4-month follow-up, 5-month follow-up, 6-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training Completion
Time Frame: Post-training (immediately after), approximately 1 hour
|
Percentage of training completed
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Post-training (immediately after), approximately 1 hour
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Satisfaction With the Intervention Video
Time Frame: Post-training (immediately after), approximately 1 hour
|
An 8-item satisfaction questionnaire, adapted from the CSQ-8, where higher scores indicate greater satisfaction.
Total scores range from 8 - 32, with higher scores indicating greater satisfaction.
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Post-training (immediately after), approximately 1 hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alan R. Teo, MD MS, VA Portland Health Care System, Portland, OR
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPO 20-166
- HX003249 (Other Grant/Funding Number: VA HSR&D)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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