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Lethal Means SafetyFFAST RCTNCT07692854

Testing Family Firearm Secure Storage Training (FFAST) to Prevent Suicide

A study testing The Family Firearms Secure storage Training (FFAST) Intervention and Health and Stress Counseling in people with Lethal Means Safety and Brief Intervention, run by VA Office of Research and Development at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
The Family Firearms Secure storage Training (FFAST) Intervention and Health and Stress Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 30 Sep 2030
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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Veteran Inclusion Criteria:
  • 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
Show all 16Show fewer
  • willing to participate in the follow-up
  • technology available to complete the appointment remotely (e.g., computer, tablet, phone)
  • CSO Inclusion Criteria:
  • 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)

Who cannot join

  • Veteran Exclusion Criteria:
  • 1) At imminent risk of suicide or homicide warranting crisis intervention (Veterans can participate once stabilized)
  • CSO Exclusion Criteria:
  • 1) At imminent risk of suicide or homicide warranting crisis intervention (CSOs can participate once stabilized)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bryann R DeBeer, PhD contact

(917) 208-1071

Bryann.DeBeer@va.gov

Alexis Blessing, PhD contact

(720) 723-4808

alexis.blessing@va.gov

United States1 site
  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211

    Bryann R DeBeer, PhD, (917) 208-1071, Bryann.DeBeer@va.gov

    Bryann R DeBeer, PhD

Other trials in United States

About this study

Official title: Improving Secure Storage of Firearms to Reduce Suicide Deaths: A Hybrid Type 1 Implementation Effectiveness Randomized Controlled Trial of the Family Firearms Secure Storage Training (FFAST) Intervention

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.

Read the detailed description

Firearm injuries are the most common lethal means in Veteran suicides (73%; VA, 2024). Storing firearms unlocked and/or loaded is associated with greater risk for suicide via firearm. Time and distance from firearms are critical, especially when an individual may be experiencing a crisis exacerbated by an existing mental health condition. New suicide prevention interventions are needed that reach individuals before the onset of a mental health crisis, and Veterans indicate they desire to include a concerned significant other (CSO; e.g., family member, friend) in their suicide prevention care. Innovation and Impact: Aligned with the VA National Strategy for Suicide Prevention goal of to developing programs that promote Veteran well-being, prevent suicide, and establish contingencies to reduce access to lethal means in the onset of suicide-related behaviors, the goal of this proposed study is to evaluate The Family FireArms Secure Storage Training (FFAST). The FFAST intervention is a single-session lethal means safety intervention, developed through stakeholder engagement, that incorporates the participation of a CSO to facilitate secure firearm storage prior to a mental health crisis. FFAST consists of four primary components: 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; 2) Psychoeducation: throughout the intervention, participants are briefed and engage in discussions on mental health symptoms, suicide warning signs, Veteran suicide rates and lethal means, and benefits of secure storage; 3) Secure Firearm Storage: educate and explore secure storage options with participants; and 4) Crisis Situation: participants navigate through a mock crisis scenario to practice their newly developed safety plan and increase comfort in discussing mental health and suicidal crisis. After being tested in two pilots (Suicide Prevention Research Impact Network [SPRINT], VA Health Sciences Research and Development [HSR], \& VA Office of Suicide Prevention [OSP], PI: DeBeer), collected data indicate the intervention is acceptable and feasible, and recruitment and retention procedures have been refined for future comparative testing and implementation. Specific Aims: Objective 1) Examine the relative effectiveness of FFAST against both active (i.e., Health and Stress Counseling) and waitlist control condition in increasing secure firearm storage within Veterans over time, as well as increasing CSOs' willingness to address a mental health crisis experienced by the Veteran; and Objective 2) Identify the barriers and facilitating factors of implementing the FFAST intervention within the VA Caregiver Support Program and Suicide Prevention 2.0. Methodology: Utilizing a 3-arm dynamic waitlist hybrid type I implementation/effectiveness randomized controlled trial (RCT) design, Veterans (n = 88) who store firearms in their home unlocked and/or loaded, and their CSOs (n = 88) will be recruited and randomly assigned to complete one of the three arms. Outcomes assessed at 1-,3-, and 6-month follow-up will include prevalence of engagement in secure firearm storage planning, practices (e.g., increases in locked and/or unloaded firearms or removal from home for safety), and mental health crisis preparedness in Veterans and their CSOs. In addition, a formative evaluation via key informant qualitative interviews with VA Caregiver Program and Suicide Prevention 2.0 providers and administrators (N = 20) will be conducted to facilitate future implementation efforts. Further, in-depth qualitative interviews will be conducted with a sub-set of Veterans and CSOs to understand their experiences with the intervention and inform implementation efforts. Path to Translation/Implementation: This trial will be the next step in our overall aim to prevent veteran suicide through an upstream, evidence-based suicide prevention intervention, and pave the way for FFAST to be disseminated and implemented widely across the VA.

Being tested
The Family Firearms Secure storage Training (FFAST) Intervention, Health and Stress Counseling
Keywords
Lethal Means Safety, Veterans, Suicide Prevention, Concerned Significant Others, Secure Storage, Firearms, Intervention
Medical subject headings
Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Family Firearms Secure storage Training (FFAST) InterventionBehavioural

    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.

  • Health and Stress CounselingBehavioural

    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.

Study groups in NCT07692854
Study groupRoleWhat they receive
The Family Firearms Secure storage Training (FFAST) InterventionExperimentalFAST 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.
Receives: Behavioral: The Family Firearms Secure storage Training (FFAST) Intervention
Health and Stress Counseling (HSC)Active comparatorParticipants 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.
Receives: Behavioral: Health and Stress Counseling
WaitlistNo interventionIn 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline and 1, 3, and 6 months

  2. 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).

    Measured: Baseline and 1, 3, 6 months

Secondary outcomes (1)
  1. Number of Participants Who Report Secure Firearm Storage in the Home

    Self-report assessment of how Veterans store one or all of the firearms in their home. Secure storage will be defined as either locked (using a gunlock or safe) and unloaded (ammunition removed and separate from the firearm), unlocked and unloaded, or locked and loaded. Unit of Measurement: Number of participants Measure Type: Categorical (Secure storage as defined above, Unlocked and unloaded, Locked and loaded)

    Measured: Baseline and 1, 3, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Jun 2030 (estimated)
  4. Study completion30 Sep 2030 (estimated)

Resources

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
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.
Masking
None (open label)
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07692854
Sponsor's protocol ID
HSR4-004-25M
Other IDs
25-2714, I01RD000657-01A2
Acronym
FFAST RCT
Status last verified
Jul 2026
First submitted
23 Jun 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • DeBeer BB, Matthieu MM, Degutis LC, Clafferty S, Blessing A, Quan C, Morissette SB. Firearms lethal means safety among Veterans: Attitudes toward involving a concerned significant other. J Mil Veteran Fam Health. 2025 Feb 12;11(1):23-31. doi: 10.3138/jmvfh-2023-0094. eCollection 2025 Feb 1.

    PubMed 42533921

Questions about this trial

What is this clinical trial studying?

A study testing The Family Firearms Secure storage Training (FFAST) Intervention and Health and Stress Counseling in people with Lethal Means Safety and Brief Intervention, 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 16 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: opening soon, as of the sponsor's last update on 16 Jul 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. 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?

Contact Bryann R DeBeer, PhD ((917) 208-1071, Bryann.DeBeer@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Firearm Secure Storage Plan (time frame: Baseline and 1, 3, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07692854, which also lists 2 linked publications.

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 16 Jul 2026.

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