Testing Family Firearm Secure Storage Training (FFAST) to Prevent Suicide (FFAST RCT)
2026年7月14日 更新者: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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
介入性
注册 (估计的)
176
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Bryann R DeBeer, PhD
- 电话号码:(917) 208-1071
- 邮箱:Bryann.DeBeer@va.gov
研究联系人备份
- 姓名:Alexis Blessing, PhD
- 电话号码:(720) 723-4808
- 邮箱:alexis.blessing@va.gov
学习地点
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Colorado
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Aurora、Colorado、美国、80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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接触:
- Bryann R DeBeer, PhD
- 电话号码:(917) 208-1071
- 邮箱:Bryann.DeBeer@va.gov
-
首席研究员:
- Bryann R DeBeer, PhD
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
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)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器: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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无干预: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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实验性的: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Participant Knowledge, Behaviors, and Preparedness Related to Firearm Secure Storage
大体时间: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
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants Who Report Secure Firearm Storage in the Home
大体时间: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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Bryann R DeBeer, PhD、Rocky Mountain Regional VA Medical Center, Aurora, CO
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2030年6月1日
研究完成 (估计的)
2030年9月30日
研究注册日期
首次提交
2026年6月23日
首先提交符合 QC 标准的
2026年7月7日
首次发布 (实际的)
2026年7月9日
研究记录更新
最后更新发布 (实际的)
2026年7月16日
上次提交的符合 QC 标准的更新
2026年7月14日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- HSR4-004-25M
- 25-2714 (其他标识符:VA Eastern Colorado Health Care System)
- I01RD000657-01A2 (其他赠款/资助编号:U.S. Department of Veteran Affairs)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.