- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07692854
Testing Family Firearm Secure Storage Training (FFAST) to Prevent Suicide (FFAST RCT)
2026년 7월 14일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
176
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Bryann R DeBeer, PhD
- 전화번호: (917) 208-1071
- 이메일: Bryann.DeBeer@va.gov
연구 연락처 백업
- 이름: Alexis Blessing, PhD
- 전화번호: (720) 723-4808
- 이메일: alexis.blessing@va.gov
연구 장소
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Colorado
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Aurora, Colorado, 미국, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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연락하다:
- Bryann R DeBeer, PhD
- 전화번호: (917) 208-1071
- 이메일: Bryann.DeBeer@va.gov
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수석 연구원:
- Bryann R DeBeer, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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.
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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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간섭 없음: 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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실험적: 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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participant Knowledge, Behaviors, and Preparedness Related to Firearm Secure Storage
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Who Report Secure Firearm Storage in the Home
기간: Baseline and 1, 3, 6 months
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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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Bryann R DeBeer, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2030년 6월 1일
연구 완료 (추정된)
2030년 9월 30일
연구 등록 날짜
최초 제출
2026년 6월 23일
QC 기준을 충족하는 최초 제출
2026년 7월 7일
처음 게시됨 (실제)
2026년 7월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 14일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HSR4-004-25M
- 25-2714 (기타 식별자: VA Eastern Colorado Health Care System)
- I01RD000657-01A2 (기타 보조금/기금 번호: U.S. Department of Veteran Affairs)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .