Ignite Creation Date:
2024-07-17 @ 10:40 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470867
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-14
Brief Title:
Randomized Controlled Effectiveness Trial of VA SAVE
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Randomized Controlled Effectiveness Trial of VA SAVE Suicide Prevention Gatekeeper Training for Veterans Close Supports
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 SAVE Signs Ask Validate Encourage and Expedite 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 SAVE 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 SAVE Signs Ask Validate Encourage and Expedite 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 VAs National Strategy for Preventing Veteran Suicide Suicide prevention remains VAs 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 SAVE this randomized controlled effectiveness trial will be the first to rigorously evaluate the effectiveness of VAs 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 SAVE and to explore factors impacting its potential widespread implementation Specific Aims are 1 Determine the effectiveness of VA SAVE in close supports of Veterans 2 Evaluate mediators and moderators of response to VA SAVE and 3 Using qualitative interviews and quantitative survey data identify barriers to future implementation of VA SAVE 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 SAVE using a targeted social media and digital ad campaign to recruit close supports likely to have interactions with Veterans at risk of suicide Participants N710 will be randomized to VA SAVE 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 n50 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 n32-48 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 StepsImplementation The next step in this line of research would be a hybrid type 2 trial equal focus on effectiveness and implementation VA SAVE 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 SAVE
Significance This project evaluates an upstream public health approach to suicide prevention that is closely aligned with VAs National Strategy for Preventing Veteran Suicide Suicide prevention remains VAs 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 SAVE this randomized controlled effectiveness trial will be the first to rigorously evaluate the effectiveness of VAs 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 SAVE and to explore factors impacting its potential widespread implementation Specific Aims are 1 Determine the effectiveness of VA SAVE in close supports of Veterans 2 Evaluate mediators and moderators of response to VA SAVE and 3 Using qualitative interviews and quantitative survey data identify barriers to future implementation of VA SAVE 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 SAVE using a targeted social media and digital ad campaign to recruit close supports likely to have interactions with Veterans at risk of suicide Participants N710 will be randomized to VA SAVE 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 n50 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 n32-48 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 StepsImplementation The next step in this line of research would be a hybrid type 2 trial equal focus on effectiveness and implementation VA SAVE 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 SAVE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I01HX003816-01A1 | OTHER_GRANT | None | None |