Suicide PreventionNCT06470867
Randomized Controlled Effectiveness Trial of VA S.A.V.E.
A study testing VA S.A.V.E. in people with Suicide Prevention, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Veterans are most likely to disclose suicidal thoughts to their close supports such as family and friends. These loved ones are, in turn, very interested in learning how to help a Veteran in need. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicide Prevention
- What is being tested?
- VA S.A.V.E.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 701 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Family member, caregiver, or friend of a Veteran
- Social contact with a Veteran at least once a week
Who cannot join
- Not providing a valid phone number and email address
- No internet access
- Indication of duplicate study entry
- Previously taken, or intending to soon take, VA S.A.V.E. training
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
About this study
Official title: Randomized Controlled Effectiveness Trial of VA S.A.V.E. Suicide Prevention Gatekeeper Training for Veterans' Close Supports
Veterans are most likely to disclose suicidal thoughts to their close supports such as family and friends. These loved ones are, in turn, very interested in learning how to help a Veteran in need. Close supports are uniquely poised to provide a meaningful contribution to suicide prevention, if they can learn how to effectively promote Veterans' connection to care. VA S.A.V.E. (Signs; Ask; Validate; Encourage) is a suicide prevention gatekeeper training specifically tailored to the Veteran community that teaches close supports how to identify signs of suicide risk and how to connect the at-risk person to professional treatment. The primary objective of this study is to evaluate the effectiveness of VA S.A.V.E. and to explore factors impacting its potential widespread implementation.
Read the detailed description
Background: Levels of help-seeking remain low among Veterans at risk for suicide. Veterans are most likely to disclose suicidal thoughts to close supports-family, friends, caregivers, and peers-who are, in turn, very interested in learning how they might be able to help a Veteran in need. VA S.A.V.E. (Signs; Ask; Validate; Encourage) is a suicide prevention gatekeeper training that can address this opportunity by teaching close supports the skills to identify signs of suicide risk and connect the at-risk Veteran to professional treatment.
Significance: This project evaluates an "upstream" public health approach to suicide prevention that is closely aligned with VA's National Strategy for Preventing Veteran Suicide. Suicide prevention remains VA's top clinical priority, and this project is highly responsive to multiple top VA priorities in research and clinical operations including studies testing outreach strategies to the families of Veterans and conducting clinical trials in suicide prevention.
Innovation \& Impact: Building upon a successful pilot randomized controlled trial of VA S.A.V.E., this randomized controlled effectiveness trial will be the first to rigorously evaluate the effectiveness of VA's signature suicide prevention skills training. Innovations include used of social media and digital outreach for upstream suicide prevention in Veterans not in VA care and use of standardized patient simulation as a method to assess participants' suicide prevention skills.
Specific Aims: The primary objective of this study is to evaluate the effectiveness of VA S.A.V.E. and to explore factors impacting its potential widespread implementation. Specific Aims are: 1) Determine the effectiveness of VA S.A.V.E. in close supports of Veterans; 2) Evaluate mediators and moderators of response to VA S.A.V.E.; and 3) Using qualitative interviews and quantitative survey data, identify barriers to future implementation of VA S.A.V.E. and potential strategies for overcoming them in a diverse sample of close supports of Veterans.
Methodology: The investigators will conduct a randomized controlled effectiveness trial of VA S.A.V.E. using a targeted social media and digital ad campaign to recruit close supports likely to have interactions with Veterans at risk of suicide. Participants (N=710) will be randomized to VA S.A.V.E. versus an informational video (control). The investigators will conduct follow-up surveys over 12 months. The primary outcomes comprise use of gatekeeper behaviors (inquiring about suicidal ideation, recommending professional treatment, and providing suicide prevention hotline information). In a subgroup of participants split equally between treatment arms (n=50), the investigators will also assess suicide prevention skills using a standardized patient simulation. Finally, guided by the Proctor taxonomy as an implementation framework, the investigators will interview a subgroup of participants (n=32-48) to understand their experiences talking about suicide with at-risk Veterans and identify barriers and facilitators to implementation of the training in close supports.
Next Steps/Implementation: The next step in this line of research would be a hybrid type 2 trial (equal focus on effectiveness and implementation). VA S.A.V.E. is free, brief, and accessible training, making it highly amenable to being rapidly taken to scale. Project findings can be used to quickly inform VA social media campaigns and other community-based efforts to disseminate VA S.A.V.E.
- Conditions
- Suicide Prevention
- Being tested
- VA S.A.V.E., Control training
- Keywords
- Mental Health Services, Suicide, Education, Distance
- Medical subject headings
- Suicide Prevention, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA S.A.V.E.Behavioural
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.
Control trainingBehavioural
An attention control informational video containing information relevant to veterans' mental health but not including elements thought to be "active ingredients" in the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | VA S.A.V.E. Training Receives: Behavioral: VA S.A.V.E. |
| Control | Sham comparator | Myths and Facts of Wounded Warriors Receives: Behavioral: Control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Gatekeeper Behaviors Used
Number of gatekeeper behaviors used (sum): Gatekeeper behaviors are comprised of three survey items: 1) ask if having suicidal thoughts ("[In the past month] how many times did you directly ask a person if they were having suicidal thoughts?"); 2) recommend professional treatment ("How many times did you tell a person having suicidal thoughts to see their doctor, go to the emergency room, call 911, or get any other professional treatment?"); and 3) provide suicide prevention hotline information ("How many times did you give a person having suicidal thoughts information about a suicide prevention hotline such as 988, the Veterans Crisis Line or Military Crisis Line?").
A higher score indicates a better outcome.
Measured: 6-month follow-up
Secondary outcomes (4)
Ask if having suicidal thoughts
Count of Gatekeeper Behavior 1) Ask if having suicidal thoughts. A higher score indicates a better outcome.
Measured: 6-month follow-up
Recommend professional treatment
Count of Gatekeeper Behavior 2) Recommend professional treatment. A higher score indicates a better outcome.
Measured: 6-month follow-up
Provide suicide prevention hotline information
Count of Gatekeeper Behavior 3) Provide suicide prevention hotline information. A higher score indicates a better outcome.
Measured: 6-month follow-up
Suicide Prevention Skills
6-item, coder/clinician-administered scale that assesses: 1) Recognizing Signs of suicide risk; 2) Asking about presence of suicidal thoughts; 3) Validating the Veteran's experience ; 4) Encouraging professional treatment and Expediting getting; 5) Asking about lethal means safety; and 6) empathy/expression of care
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start21 Nov 2024
- Primary completion27 Nov 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to either the intervention or the control group. Participants will be randomized 1:1 to either the intervention or the control group. Computer-generated block-randomization schemes using random block sizes generated in Stata (v17) to assign the two study arms will be created before study start. The intervention, called VA S.A.V.E., is an online, video-based training tailored to veterans and their close supports. The control will watch an information video intended to control for attention received but not including elements thought to be "active ingredients" in the intervention. The informational video will be similar to the intervention in duration and will also contain other design features similar to the intervention (e.g., motion graphics).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 701 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alan R. Teo, MD MS, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470867
- Sponsor's protocol ID
- SDR 23-066
- Other IDs
- I01HX003816-01A1
- Status last verified
- May 2026
- First submitted
- 14 Jun 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Effectiveness Trial of VA S.A.V.E. Suicide Prevention Gatekeeper Training for Veterans' Close Supports
- ClinicalTrials.gov ID
- NCT06470867
- Acronym / sponsor ID
- SDR 23-066
- Conditions
- Suicide Prevention
- Keywords
- Mental Health Services, Suicide, Education, Distance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 701 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 27 Nov 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Veterans are most likely to disclose suicidal thoughts to their close supports such as family and friends. These loved ones are, in turn, very interested in learning how to help a Veteran in need. Close supports are uniquely poised to provide a meaningful contribution to suicide prevention, if they can learn how to effectively promote Veterans' connection to care. VA S.A.V.E. (Signs; Ask; Validate; Encourage) is a suicide prevention gatekeeper training specifically tailored to the Veteran community that teaches close supports how to identify signs of suicide risk and how to connect the at-risk person to professional treatment. The primary objective of this study is to evaluate the effectiveness of VA S.A.V.E. and to explore factors impacting its potential widespread implementation.
Detailed description
Background: Levels of help-seeking remain low among Veterans at risk for suicide. Veterans are most likely to disclose suicidal thoughts to close supports-family, friends, caregivers, and peers-who are, in turn, very interested in learning how they might be able to help a Veteran in need. VA S.A.V.E. (Signs; Ask; Validate; Encourage) is a suicide prevention gatekeeper training that can address this opportunity by teaching close supports the skills to identify signs of suicide risk and connect the at-risk Veteran to professional treatment.
Significance: This project evaluates an "upstream" public health approach to suicide prevention that is closely aligned with VA's National Strategy for Preventing Veteran Suicide. Suicide prevention remains VA's top clinical priority, and this project is highly responsive to multiple top VA priorities in research and clinical operations including studies testing outreach strategies to the families of Veterans and conducting clinical trials in suicide prevention.
Innovation \& Impact: Building upon a successful pilot randomized controlled trial of VA S.A.V.E., this randomized controlled effectiveness trial will be the first to rigorously evaluate the effectiveness of VA's signature suicide prevention skills training. Innovations include used of social media and digital outreach for upstream suicide prevention in Veterans not in VA care and use of standardized patient simulation as a method to assess participants' suicide prevention skills.
Specific Aims: The primary objective of this study is to evaluate the effectiveness of VA S.A.V.E. and to explore factors impacting its potential widespread implementation. Specific Aims are: 1) Determine the effectiveness of VA S.A.V.E. in close supports of Veterans; 2) Evaluate mediators and moderators of response to VA S.A.V.E.; and 3) Using qualitative interviews and quantitative survey data, identify barriers to future implementation of VA S.A.V.E. and potential strategies for overcoming them in a diverse sample of close supports of Veterans.
Methodology: The investigators will conduct a randomized controlled effectiveness trial of VA S.A.V.E. using a targeted social media and digital ad campaign to recruit close supports likely to have interactions with Veterans at risk of suicide. Participants (N=710) will be randomized to VA S.A.V.E. versus an informational video (control). The investigators will conduct follow-up surveys over 12 months. The primary outcomes comprise use of gatekeeper behaviors (inquiring about suicidal ideation, recommending professional treatment, and providing suicide prevention hotline information). In a subgroup of participants split equally between treatment arms (n=50), the investigators will also assess suicide prevention skills using a standardized patient simulation. Finally, guided by the Proctor taxonomy as an implementation framework, the investigators will interview a subgroup of participants (n=32-48) to understand their experiences talking about suicide with at-risk Veterans and identify barriers and facilitators to implementation of the training in close supports.
Next Steps/Implementation: The next step in this line of research would be a hybrid type 2 trial (equal focus on effectiveness and implementation). VA S.A.V.E. is free, brief, and accessible training, making it highly amenable to being rapidly taken to scale. Project findings can be used to quickly inform VA social media campaigns and other community-based efforts to disseminate VA S.A.V.E.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to either the intervention or the control group. Participants will be randomized 1:1 to either the intervention or the control group. Computer-generated block-randomization schemes using random block sizes generated in Stata (v17) to assign the two study arms will be created before study start. The intervention, called VA S.A.V.E., is an online, video-based training tailored to veterans and their close supports. The control will watch an information video intended to control for attention received but not including elements thought to be "active ingredients" in the intervention. The informational video will be similar to the intervention in duration and will also contain other design features similar to the intervention (e.g., motion graphics).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: VA S.A.V.E.VA S.A.V.E. Training |
| Control | Sham comparator | Behavioral: Control trainingMyths and Facts of Wounded Warriors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Family member, caregiver, or friend of a Veteran
- Social contact with a Veteran at least once a week
Key exclusion criteria (4 listed)
- Not providing a valid phone number and email address
- No internet access
- Indication of duplicate study entry
- Previously taken, or intending to soon take, VA S.A.V.E. training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
| Control trainingAn attention control informational video containing information relevant to veterans' mental health but not including elements thought to be "active ingredients" in the intervention. | Behavioural | Control |
Primary outcome
Count of Gatekeeper Behaviors Used
Time frame: 6-month follow-up
Number of gatekeeper behaviors used (sum): Gatekeeper behaviors are comprised of three survey items: 1) ask if having suicidal thoughts ("[In the past month] how many times did you directly ask a person if they were having suicidal thoughts?"); 2) recommend professional treatment ("How many times did you tell a person having suicidal thoughts to see their doctor, go to the emergency room, call 911, or get any other professional treatment?"); and 3) provide suicide prevention hotline information ("How many times did you give a person having suicidal thoughts information about a suicide prevention hotline such as 988, the Veterans Crisis Line or Military Crisis Line?"). A higher score indicates a better outcome.
4 secondary outcomes
Ask if having suicidal thoughts
Time frame: 6-month follow-up
Recommend professional treatment
Time frame: 6-month follow-up
Provide suicide prevention hotline information
Time frame: 6-month follow-up
Suicide Prevention Skills
Time frame: 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan R. Teo, MD MS principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VA S.A.V.E. in people with Suicide Prevention, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Gatekeeper Behaviors Used (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.