- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07692854
Testing Family Firearm Secure Storage Training (FFAST) to Prevent Suicide (FFAST RCT)
14 juli 2026 uppdaterad av: VA Office of Research and Development
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.
Studieöversikt
Status
Har inte rekryterat ännu
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
176
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Bryann R DeBeer, PhD
- Telefonnummer: (917) 208-1071
- E-post: Bryann.DeBeer@va.gov
Studera Kontakt Backup
- Namn: Alexis Blessing, PhD
- Telefonnummer: (720) 723-4808
- E-post: alexis.blessing@va.gov
Studieorter
-
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Colorado
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Aurora, Colorado, Förenta staterna, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
Kontakt:
- Bryann R DeBeer, PhD
- Telefonnummer: (917) 208-1071
- E-post: Bryann.DeBeer@va.gov
-
Huvudutredare:
- Bryann R DeBeer, PhD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
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
- 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)
Exclusion Criteria:
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Health and Stress Counseling (HSC)
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.
|
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.
|
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Inget ingripande: Waitlist
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.
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Experimentell: The Family Firearms Secure storage Training (FFAST) Intervention
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.
|
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Participant Knowledge, Behaviors, and Preparedness Related to Firearm Secure Storage
Tidsram: Baseline and 1, 3, 6 months
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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).
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Baseline and 1, 3, 6 months
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Number of Participants With a Firearm Secure Storage Plan
Tidsram: Baseline and 1, 3, and 6 months
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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
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Baseline and 1, 3, and 6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants Who Report Secure Firearm Storage in the Home
Tidsram: Baseline and 1, 3, 6 months
|
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)
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Baseline and 1, 3, 6 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Bryann R DeBeer, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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
- 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
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 oktober 2026
Primärt slutförande (Beräknad)
1 juni 2030
Avslutad studie (Beräknad)
30 september 2030
Studieregistreringsdatum
Först inskickad
23 juni 2026
Först inskickad som uppfyllde QC-kriterierna
7 juli 2026
Första postat (Faktisk)
9 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HSR4-004-25M
- 25-2714 (Annan identifierare: VA Eastern Colorado Health Care System)
- I01RD000657-01A2 (Annat bidrag/finansieringsnummer: U.S. Department of Veteran Affairs)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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