Trial Outcomes & Findings for Increasing Help-Seeking Behavior Among Transitioning Veterans at Risk for Suicide With Online Gatekeeper Training (NCT NCT04565951)
NCT ID: NCT04565951
Last Updated: 2024-03-28
Results Overview
Number enrolled; proportion of eligible who enroll
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
281 participants
Primary outcome timeframe
baseline (T=0)
Results posted on
2024-03-28
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
130
|
|
Overall Study
Responded to Baseline Survey
|
112
|
102
|
|
Overall Study
COMPLETED
|
71
|
84
|
|
Overall Study
NOT COMPLETED
|
80
|
46
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
66
|
38
|
|
Overall Study
Withdrawal by Subject
|
14
|
7
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Increasing Help-Seeking Behavior Among Transitioning Veterans at Risk for Suicide With Online Gatekeeper Training
Baseline characteristics by cohort
| Measure |
Sham Arm
n=112 Participants
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.
|
Treatment Arm
n=102 Participants
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.
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.1 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
54.3 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex/Gender, Customized
Male/man
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female/woman
|
99 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Genderqueer/non-binary
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
107 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Veteran status
No, never served
|
77 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Veteran status
Yes, now on active duty
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Veteran status
Yes, active duty in the past
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Number enrolled; proportion of eligible who enroll
Outcome measures
| Measure |
All Participants
n=1278 Participants
This group includes all participants prior to randomization.
|
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.
|
|---|---|---|
|
Recruitment
Enrolled
|
281 Participants
|
—
|
|
Recruitment
Not enrolled
|
997 Participants
|
—
|
PRIMARY outcome
Timeframe: 1-month follow-up, 2-month follow-up, 3-month follow-up, 4-month follow-up, 5-month follow-up, 6-month follow-upPopulation: This includes all those who completed baseline.
Survey completion at each survey timepoint
Outcome measures
| Measure |
All Participants
n=112 Participants
This group includes all participants prior to randomization.
|
Treatment Arm
n=102 Participants
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.
|
|---|---|---|
|
Survey Completion Rates
Completed 1-month follow up
|
71 Participants
|
79 Participants
|
|
Survey Completion Rates
Completed 2-month follow up
|
68 Participants
|
82 Participants
|
|
Survey Completion Rates
Completed 3-month follow up
|
63 Participants
|
80 Participants
|
|
Survey Completion Rates
Completed 4-month follow up
|
67 Participants
|
82 Participants
|
|
Survey Completion Rates
Completed 5-month follow up
|
66 Participants
|
78 Participants
|
|
Survey Completion Rates
Completed 6-month follow up
|
71 Participants
|
84 Participants
|
SECONDARY outcome
Timeframe: Post-training (immediately after), approximately 1 hourPopulation: All those who at least started the training video are included here.
Percentage of training completed
Outcome measures
| Measure |
All Participants
n=112 Participants
This group includes all participants prior to randomization.
|
Treatment Arm
n=102 Participants
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.
|
|---|---|---|
|
Training Completion
|
66.1 percentage of video watched
Interval 58.2 to 73.9
|
76.6 percentage of video watched
Interval 69.3 to 83.8
|
SECONDARY outcome
Timeframe: Post-training (immediately after), approximately 1 hourPopulation: This includes all those who completed the post-training survey.
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.
Outcome measures
| Measure |
All Participants
n=100 Participants
This group includes all participants prior to randomization.
|
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.
|
|---|---|---|
|
Satisfaction With the Intervention Video
|
26.6 units on a scale
Standard Deviation 4.3
|
—
|
Adverse Events
Sham Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alan Teo
Center to Improve Veteran Involvement in Care (CIVIC), HSR&D Center of Innovation, VA Portland Health Care System
Phone: 503-220-8262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place