Skip to content

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04565951
Enrollment
281
Registered
2020-09-28
Start date
2021-03-13
Completion date
2021-12-14
Last updated
2024-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide Prevention

Keywords

suicide, suicide prevention, mental health, veterans

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.

Interventions

BEHAVIORALVA S.A.V.E.

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.

BEHAVIORALSham intervention

A sham training consisting of information unrelated to suicide prevention but relevant to transitioning veterans and their loved ones.

Sponsors

Canandaigua VA Medical Center
CollaboratorFED
PsychArmor Institute
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Masking description

Participants will be blinded by limiting details about the study hypotheses and differences between the study arms. Blinding will also be achieved because no study personnel are involved in intervention delivery. The biostatistician will be blinded for analyses involving study group comparisons.

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Recruitmentbaseline (T=0)Number enrolled; proportion of eligible who enroll
Survey Completion Rates1-month follow-up, 2-month follow-up, 3-month follow-up, 4-month follow-up, 5-month follow-up, 6-month follow-upSurvey completion at each survey timepoint

Secondary

MeasureTime frameDescription
Training CompletionPost-training (immediately after), approximately 1 hourPercentage of training completed
Satisfaction With the Intervention VideoPost-training (immediately after), approximately 1 hourAn 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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited via a social media campaign that ran a series of sponsored ads on Facebook from March 13, 2021 to May 24, 2021.

Participants by arm

ArmCount
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. Sham intervention: A sham training consisting of information unrelated to suicide prevention but relevant to transitioning veterans and their loved ones.
112
Treatment Arm
Participants in this arm will receive the intervention, VA S.A.V.E. VA S.A.V.E.: 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.
102
Total214

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath01
Overall StudyLost to Follow-up6638
Overall StudyWithdrawal by Subject147

Baseline characteristics

CharacteristicSham ArmTreatment ArmTotal
Age, Continuous53.1 years
STANDARD_DEVIATION 13.8
55.6 years
STANDARD_DEVIATION 12.7
54.3 years
STANDARD_DEVIATION 13.3
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants4 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
107 Participants97 Participants204 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants1 Participants3 Participants
Race (NIH/OMB)
More than one race
6 Participants5 Participants11 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants4 Participants6 Participants
Race (NIH/OMB)
White
102 Participants90 Participants192 Participants
Sex/Gender, Customized
Female/woman
99 Participants90 Participants189 Participants
Sex/Gender, Customized
Genderqueer/non-binary
2 Participants1 Participants3 Participants
Sex/Gender, Customized
Male/man
11 Participants11 Participants22 Participants
Veteran status
No, never served
77 Participants69 Participants146 Participants
Veteran status
Yes, active duty in the past
30 Participants30 Participants60 Participants
Veteran status
Yes, now on active duty
5 Participants3 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1511 / 130
other
Total, other adverse events
0 / 1510 / 130
serious
Total, serious adverse events
0 / 1510 / 130

Outcome results

Primary

Recruitment

Number enrolled; proportion of eligible who enroll

Time frame: baseline (T=0)

Population: For the purposes of assessing the proportion of eligible participants who enroll, this group includes all those who completed the online screener and screened in as eligible.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
All ParticipantsRecruitmentEnrolled281 Participants
All ParticipantsRecruitmentNot enrolled997 Participants
Primary

Survey Completion Rates

Survey completion at each survey timepoint

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

Population: This includes all those who completed baseline.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
All ParticipantsSurvey Completion RatesCompleted 1-month follow up71 Participants
All ParticipantsSurvey Completion RatesCompleted 2-month follow up68 Participants
All ParticipantsSurvey Completion RatesCompleted 3-month follow up63 Participants
All ParticipantsSurvey Completion RatesCompleted 4-month follow up67 Participants
All ParticipantsSurvey Completion RatesCompleted 5-month follow up66 Participants
All ParticipantsSurvey Completion RatesCompleted 6-month follow up71 Participants
Treatment ArmSurvey Completion RatesCompleted 5-month follow up78 Participants
Treatment ArmSurvey Completion RatesCompleted 1-month follow up79 Participants
Treatment ArmSurvey Completion RatesCompleted 4-month follow up82 Participants
Treatment ArmSurvey Completion RatesCompleted 2-month follow up82 Participants
Treatment ArmSurvey Completion RatesCompleted 6-month follow up84 Participants
Treatment ArmSurvey Completion RatesCompleted 3-month follow up80 Participants
Secondary

Satisfaction With the Intervention Video

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.

Time frame: Post-training (immediately after), approximately 1 hour

Population: This includes all those who completed the post-training survey.

ArmMeasureValue (MEAN)Dispersion
All ParticipantsSatisfaction With the Intervention Video26.6 units on a scaleStandard Deviation 4.3
Secondary

Training Completion

Percentage of training completed

Time frame: Post-training (immediately after), approximately 1 hour

Population: All those who at least started the training video are included here.

ArmMeasureValue (MEAN)
All ParticipantsTraining Completion66.1 percentage of video watched
Treatment ArmTraining Completion76.6 percentage of video watched

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026