Testing Family Firearm Secure Storage Training (FFAST) to Prevent Suicide (FFAST RCT)
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
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Bryann R DeBeer, PhD
- Número de teléfono: (917) 208-1071
- Correo electrónico: Bryann.DeBeer@va.gov
Copia de seguridad de contactos de estudio
- Nombre: Alexis Blessing, PhD
- Número de teléfono: (720) 723-4808
- Correo electrónico: alexis.blessing@va.gov
Ubicaciones de estudio
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Colorado
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Aurora, Colorado, Estados Unidos, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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Contacto:
- Bryann R DeBeer, PhD
- Número de teléfono: (917) 208-1071
- Correo electrónico: Bryann.DeBeer@va.gov
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Investigador principal:
- Bryann R DeBeer, PhD
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Comparador activo: 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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Sin intervención: 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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Participant Knowledge, Behaviors, and Preparedness Related to Firearm Secure Storage
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants Who Report Secure Firearm Storage in the Home
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Bryann R DeBeer, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO
Publicaciones y enlaces útiles
Publicaciones Generales
- 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- HSR4-004-25M
- 25-2714 (Otro identificador: VA Eastern Colorado Health Care System)
- I01RD000657-01A2 (Otro número de subvención/financiamiento: U.S. Department of Veteran Affairs)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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