NCT04565951

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

March 13, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2021

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 28, 2024

Completed
Last Updated

March 28, 2024

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

September 21, 2020

Results QC Date

November 2, 2022

Last Update Submit

September 29, 2023

Conditions

Suicide Prevention

Keywords

suicidesuicide preventionmental healthveterans

Outcome Measures

Primary Outcomes (2)

  • Recruitment

    Number enrolled; proportion of eligible who enroll

    baseline (T=0)

  • Survey Completion Rates

    Survey completion at each survey timepoint

    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 (2)

  • Training Completion

    Post-training (immediately after), approximately 1 hour

  • Satisfaction With the Intervention Video

    Post-training (immediately after), approximately 1 hour

Study Arms (2)

Treatment arm

EXPERIMENTAL

Participants in this arm will receive the intervention, VA S.A.V.E.

Behavioral: VA S.A.V.E.

Sham arm

SHAM COMPARATOR

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.

Behavioral: Sham intervention

Interventions

VA S.A.V.E.BEHAVIORAL

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.

Treatment arm
Sham interventionBEHAVIORAL

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

Sham arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

    PMID: 36159001RESULT

MeSH Terms

Conditions

Suicide PreventionSuicidePsychological Well-Being

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorPersonal Satisfaction

Results Point of Contact

Title
Dr. Alan Teo
Organization
Center to Improve Veteran Involvement in Care (CIVIC), HSR&D Center of Innovation, VA Portland Health Care System
alan.teo@va.gov
503-220-8262

Study Officials

  • Alan R. Teo, MD MS

    VA Portland Health Care System, Portland, OR

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 28, 2020

Study Start

March 13, 2021

Primary Completion

December 14, 2021

Study Completion

December 14, 2021

Last Updated

March 28, 2024

Results First Posted

March 28, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)