NCT07692854

Brief Summary

Firearms are the lethal means used in over 70% of Veteran suicides with rates of Veteran deaths via self-induced firearm injury rising dramatically (by 64.8%) from 2001 to 2022. Upstream, evidence-based lethal means safety interventions are urgently needed within the VA to address this serious issue. The Family Firearms Secure Storage Training (FFAST) intervention consists of single session in which Veterans and their concerned significant others (CSOs) are guided through a discussion on secure firearm storage practices and develop a safety plan to prepare them for a mental health crisis. This study aims to evaluate the relative effectiveness of FFAST against a control condition in promoting secure firearm storage planning, preparedness for a mental health crisis, and secure storage practices within Veterans and their CSOs. In addition, barriers and facilitating factors of implementing FFAST within the VA Caregiver Support Program and Suicide Prevention 2.0 will be examined to aid in the widespread adoption of FFAST across the VA.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

June 23, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2030

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

3.7 years

First QC Date

June 23, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

Lethal Means SafetyVeteransSuicide PreventionConcerned Significant OthersSecure StorageFirearmsIntervention

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With a Firearm Secure Storage Plan

    Participants will be asked via survey their if they have a plan (yes/no), if the plan is written down, and if they have discussed the plan with their Veteran or CSO. Unit of Measurement: Number of participants

    Baseline and 1, 3, and 6 months

  • Participant Knowledge, Behaviors, and Preparedness Related to Firearm Secure Storage

    Participants will self-report their knowledge, behaviors, and preparedness for enacting a firearm secure storage plan. Three survey items created for this trial will include knowledge of mental health warning signs, willingness to participate in planning, and preparedness for a mental health crisis. Unit of Measurement: Total scores of these items will range from 5 - 15, and are rated on a scale of 1 to 5, with higher scores indicating greater levels of agreement on understanding (Definitely Disagree - Definitely Agree) or willingness (Not Willing - Totally Willing).

    Baseline and 1, 3, 6 months

Secondary Outcomes (1)

  • Number of Participants Who Report Secure Firearm Storage in the Home

    Baseline and 1, 3, 6 months

Study Arms (3)

The Family Firearms Secure storage Training (FFAST) Intervention

EXPERIMENTAL

FAST is a brief, single-session intervention where Veterans collaborate with a family member or friend (referred to as a concerned significant other; CSO) to create a secure storage plan for firearms in the event they ever experience a mental health crisis.

Behavioral: The Family Firearms Secure storage Training (FFAST) Intervention

Health and Stress Counseling (HSC)

ACTIVE COMPARATOR

Participants will participate in an intervention similar in length and delivery of the experimental condition, however the intervention does not focus on lethal means safety, secure storage of firearms, or suicide prevention.

Behavioral: Health and Stress Counseling

Waitlist

NO INTERVENTION

In the waitlist control condition, participants will be assigned to complete either FFAST or HSC 6-months after the start of the study. Their data for those 6 months will be compared to the intervention (FFAST) and the active control (HSC). This will allow researchers to compare the results of those who are assigned to either FFAST, HSC, or nothing, while still providing participants an active condition at a later time.

Interventions

The intervention consists of a brief, single-session intervention where a Veteran and their CSO work together to create a secure storage plan for firearms in the home in the event the Veteran experiences a mental health crisis, and how the CSO can support the Veteran during a crisis. This intervention can be used by any Veteran who owns firearms, and neither the Veteran nor CSO need to be experiencing mental health symptoms to participate. The intervention serves as an upstream method of suicide prevention that can be delivered in-person, through a telehealth appointment, or over the phone.

The Family Firearms Secure storage Training (FFAST) Intervention

HSC is a brief intervention where Veterans and their CSOs meet with an interventionist to learn how to support a Veteran's well-being. Areas include diet, exercise, sleep, stress, and other factors that may impact overall health.

Health and Stress Counseling (HSC)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled or eligible to be enrolled in the VA healthcare system
  • enrolled in the Caregiver Program
  • able to comprehend the informed consent form and provide consent over the phone or via teleconference
  • firearm owner in which they report at least 1 firearm is currently located in the home and stored in an unsecure manner (e.g., unlocked and/or loaded)
  • an identifiable CSO enrolled in the VA CSP who agrees to participate
  • willing to participate in the follow-up
  • technology available to complete the appointment remotely (e.g., computer, tablet, phone)
  • CSO of Veteran participant (e.g., spouse, friend, relative)
  • enrolled in the VA CSP
  • able to comprehend the informed consent form and provide consent over the phone or via teleconference
  • willing to participate in the follow-up
  • willing to assist the Veteran with secure firearm storage
  • willing to participate in the follow-up
  • technology available to complete the appointment remotely (e.g., computer, tablet, phone)

You may not qualify if:

  • \) At imminent risk of suicide or homicide warranting crisis intervention (Veterans can participate once stabilized)
  • \) At imminent risk of suicide or homicide warranting crisis intervention (CSOs can participate once stabilized)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

Related Publications (2)

  • DeBeer B.B, Blessing, A., Degutis, C. D., Matthieu, M. M., Karras, E., Cassidy, R. C., Simonetti, J. A., Borah, E., Mignogna, J. & Morissette, S. B. (2026). Involving concerned significant others in firearm suicide prevention: Development of the Family FireArms Safety Training (FFAST) Intervention. Federal Practitioner, 43(suppl 1), ;S1-S7. https://www.doi.org/10.12788/fp.0695

    BACKGROUND
  • DeBeer, B. B., Mattheiu, M. M., Degutis, L. C., Clafferty, S., Blessing, A., Quan, C., & Morissette, S. B. (2025). Firearms lethal means safety in veterans: Attitudes towards involving a concerned significant other. Journal of Military, Veteran, and Family Health, 11(1). https://doi.org/10.3138/jmvfh-2023-0094

    BACKGROUND

MeSH Terms

Conditions

Suicide Prevention

Interventions

MethodsHealth

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative TechniquesPopulation Characteristics

Study Officials

  • Bryann R DeBeer, PhD

    Rocky Mountain Regional VA Medical Center, Aurora, CO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryann R DeBeer, PhD

CONTACT

Alexis Blessing, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: FFAST is a brief, single session intervention that incorporates military culture, directly fostering social support, and targeting risk well in advance of a crisis. Following 4 components are emphasized in FFAST: 1) CSO involvement: Participants are briefed on the importance and role of the CSO in the intervention, how they serve as an encouraging support person for the Veteran, and that initiating such contact with a CSO is designed to promote secure storage. 2) Psychoeducation: Throughout the intervention, participants are briefed and engage in discussions on mental health symptoms, suicide warning signs, Veteran suicide rates, secure storage, and benefits of secure storage. 3) Promoting secure firearm storage: The goal of this component is to educate and explore secure storage options. 4) Crisis Situation: CSOs and Veterans navigate through a mock crisis scenario to allow them to practice their newly developed secure storage and potential crisis plan.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 9, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

September 30, 2030

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations