SecureHomes Randomized Clinical Trial (SecureHomes)
A Randomized Clinical Trial of the VA Secure Homes Lethal Means Intervention for Veterans With Elevated Suicide Risk
Firearm suicide prevention is a leading VA priority. To date, no intervention has been shown to encourage Veterans with elevated suicide risk to adopt secure firearm storage practices to reduce their suicide risk. The proposed effort will test whether the SecureHomes intervention can encourage Veterans with elevated suicide risk to adopt secure firearm storage practices, such as voluntarily removing firearms from their households or securing them with locking devices.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The VA Clinical Practice Guidelines encourage clinicians to facilitate secure firearm storage for at-risk Veterans. No such intervention has ever been tested in a clinical trial among Veterans. SecureHomes is an intervention which was found to be feasible and highly acceptable to Veterans. The aim of this trial is to determine the efficacy of the SecureHomes intervention compared to an attention control condition among 400 Veteran firearm owners with elevated suicide risk.
Hypothesis 1a: Veterans who receive SecureHomes will be significantly more likely to report meaningful reductions in firearm access (MRIA) at 30 days compared to Veterans who receive the attention control.
Hypothesis 1b: Among participants who do not store their firearms locked at baseline, Veterans who receive SecureHomes will be significantly more likely to report locking all household firearms at 30 days.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Joseph A Simonetti, MD MPH
- Número de teléfono: (330) 714-1648
- Correo electrónico: Joseph.Simonetti@va.gov
Copia de seguridad de contactos de estudio
- Nombre: Shalomi Shelton, MS
- Número de teléfono: (720) 723-6810
- Correo electrónico: shalomi.shelton@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:
- Joseph A Simonetti, MD MPH
- Número de teléfono: (330) 714-1648
- Correo electrónico: Joseph.Simonetti@va.gov
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Investigador principal:
- Joseph A Simonetti, MD MPH
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Contacto:
- Shalomi Shelton, MS
- Número de teléfono: (720) 723-6810
- Correo electrónico: shalomi.shelton@va.gov
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Firearms on premises (assessed via Mental Illness Research, Education, and Clinical Center Lethal Means Safety measure)
- Owns at least one of the firearms on premises (assessed via Mental Illness Research, Education, and Clinical Center Lethal Means Safety measure)
- Has ACCESS to at least one of the firearms on premises (definition below, via Mental Illness Research, Education, and Clinical Center Lethal Means Safety measure)
- Recent VHA ED/UC, PC, OMH encounter who screen positive on the C-SSRS Screener (definition below) - (determined via recruitment database)
Exclusion Criteria:
- Severely cognitively impaired
- Lack decisional capacity
- Are unable to provide consent
- Lack phone access
- Are currently admitted to the hospital
- Have a drug use disorder with current use (other than marijuana)
- Have alcohol use disorder with daily intake
- Participated in the SecureHomes pilot study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: SecureHomes
Participants receive the SecureHomes lethal means intervention: one virtual session of about 20-30 minutes plus an optional follow-up of about 5-10 minutes. Sessions are delivered by clinicians with suicide prevention experience who are trained in firearm cultural competency and firearm-specific motivational interviewing. Participants can receive educational print materials and no-cost firearm locking devices based on their preferences. |
A virtually delivered lethal means safety intervention that aims to increase awareness of the link between firearm access and suicide risk and to encourage secure firearm storage. It uses a firearm-specific motivational interviewing approach developed by the study team. It encourages meaningful reduction in firearm access (MRIA) for all participants, and locking all firearms for those not ready to adopt MRIA. Based on participant preference, the study team ships educational print materials and no-cost locking devices (lockboxes and cable locks) to participants' homes. |
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Comparador activo: Attention Control
Participants receive Health and Stress Counseling, matched in time to the SecureHomes arm: one virtual session of about 20-30 minutes plus an optional follow-up of about 5-10 minutes. Sessions focus on promoting healthy, stress-reducing behaviors and contain no active components specific to firearm storage. |
An attention control condition matched to SecureHomes in session length and follow-up. Sessions promote healthy and stress-reducing behaviors and contain no firearm-storage knowledge, motivation, or resources. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Meaningful Reduction in Firearm Access (MRIA) at 30 Days
Periodo de tiempo: 30 days
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MRIA is assessed with the Mental Illness Research, Education, and Clinical Center (MIRECC) Lethal Means Measure. MRIA includes: removal of all household firearms, removal of all household ammunition, all firearms locked with the participant lacking the key or code, all ammunition locked with the participant lacking the key or code, or the firearm disassembled with a critical part kept away from the participant. |
30 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants Who Lock All Household Firearms at 30 Days Among Those Not Locking All Firearms at Baseline
Periodo de tiempo: 30 days
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Assessed with the Mental Illness Research, Education, and Clinical Center (MIRECC) Lethal Means Measure. Participants who stored any household firearm unlocked at baseline are assessed at 30 days. A participant counts if all household firearms are stored locked, using an external locking device or a locked container. |
30 days
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Other Increases in Locked Firearm Storage at 30 Days
Periodo de tiempo: 30 days
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Assessed with the Mental Illness Research, Education, and Clinical Center (MIRECC) Lethal Means Measure. Includes incremental changes in locked firearm storage, including moving from no firearms locked to some firearms locked. |
30 days
|
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Number of Participants With Increases in Unloaded Firearm Storage at 30 Days
Periodo de tiempo: 30 days
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Assessed with the Mental Illness Research, Education, and Clinical Center (MIRECC) Lethal Means Measure. Includes incremental changes in unloaded firearm storage, including from none unloaded to some unloaded, and some unloaded to all unloaded. |
30 days
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Number of Participants Storing Any Firearm Loaded and Unlocked at 30 Days
Periodo de tiempo: 30 days
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Any firearm loaded and unlocked. |
30 days
|
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Change in Beliefs About the Importance of Locked Firearm Storage
Periodo de tiempo: Baseline and 30 days
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Changes in agreement from baseline to 30 days in beliefs about the importance of locked firearm storage. Rated on 1-10 scale. |
Baseline and 30 days
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Change in Firearm Removal Beliefs
Periodo de tiempo: Baseline and 30 days
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Changes in agreement from baseline to 30 days in beliefs about the importance of removing firearms from the household. Rated on 1-10 scale. |
Baseline and 30 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joseph A Simonetti, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HSR4-030-25W
- 1I01RD001918-01A1 (Otro número de subvención/financiamiento: Veterans Health Administration)
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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