Randomized Controlled Effectiveness Trial of VA S.A.V.E.

NCT06470867 | Recruiting

• 2 other identifiers: SDR 23-066I01HX003816-01A1
• Study Type: interventional
• Target: 710
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Suicide Prevention

Keywords

Mental Health Services; Suicide; Education, Distance

Outcome Measures

Primary Outcomes (1)

• 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.

  6-month follow-up

Secondary Outcomes (4)

• Ask if having suicidal thoughts

  6-month follow-up

• Recommend professional treatment

  6-month follow-up

• Provide suicide prevention hotline information

  6-month follow-up

• Suicide Prevention Skills

  3-month follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

VA S.A.V.E. Training

Behavioral: VA S.A.V.E.

Control

SHAM COMPARATOR

Myths and Facts of Wounded Warriors

Behavioral: Control training

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.

Intervention

Control training BEHAVIORAL

An attention control informational video containing information relevant to veterans' mental health but not including elements thought to be "active ingredients" in the intervention.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Family member, caregiver, or friend of a Veteran
• Social contact with a Veteran at least once a week

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

RECRUITING

MeSH Terms

Conditions

Suicide Prevention; Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Alan R. Teo, MD MS

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlin M Leonard, BA

CONTACT

(503) 220-8262; kaitlin.leonard@va.gov

Aaron A Call

CONTACT

(503) 220-8262; Aaron.Call@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Following recommendations for blinding in behavioral interventions, participants will be blinded by limiting details about the study hypotheses and differences between the study arms. Furthermore, research staff involved in outcome assessment and study biostatisticians involved in data analysis will be blinded to study arms.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 24, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): May 21, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)