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Набор скоро начнётся NCT07692854

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

Без фазы С лечением Lethal Means Safety Brief Intervention Concern Significant Others

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: The Family Firearms Secure storage Training (FFAST) Intervention, Health and Stress Counseling.
Кому может быть актуально
Состояния в реестре: Lethal Means Safety, Brief Intervention, Concern Significant Others. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое The Family Firearms Secure storage Training (FFAST) Intervention
    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
  • Поведенческое Health and Stress Counseling
    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.

Первичные конечные точки

  • Number of Participants With a Firearm Secure Storage Plan [Срок оценки: Baseline and 1, 3, and 6 months]
  • Participant Knowledge, Behaviors, and Preparedness Related to Firearm Secure Storage [Срок оценки: Baseline and 1, 3, 6 months]
Вторичные конечные точки (1)
  • Number of Participants Who Report Secure Firearm Storage in the Home [Срок оценки: Baseline and 1, 3, 6 months]

Критерии участия

Критерии включения

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)

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora

Публикации

  • 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, 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

Идентификаторы

NCT: NCT07692854 · HSR4-004-25M · 25-2714 · I01RD000657-01A2

Первоисточники (государственные реестры)

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