- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06479889
Almacenamiento más seguro Hogares más seguros Un ensayo piloto de asesoramiento sobre medios letales pediátricos hospitalizados
Almacenamiento más seguro Hogares más seguros: investigación del uso de dispositivos de almacenamiento seguro en la población de salud conductual para pacientes hospitalizados
Firearm injuries are the leading cause of death for American youth. Strikingly, firearm suicide among adolescents is growing faster than other groups. Lethal means counseling is standard of care, however, infrequently occurs despite pediatricians recognizing the importance. Lack of time, topic discomfort, and inadequate resources for families are commonly reported barriers to counseling. By addressing these factors, we can improve counseling with the ultimate goal of increasing safe storage and reducing firearm injuries in youth.
Children admitted in acute mental health crises while awaiting psychiatric hospital placement are a population at greater risk of suicide. We plan to implement a pilot intervention to offer secure storage counseling and storage device distribution to families of behavioral health patients who indicate firearm ownership on initial screening. The goal of this project is to evaluate the feasibility and acceptability of firearm secure storage counseling and device provision in the inpatient setting.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The Behavioral Health service at Monroe Carell Jr Children's Hospital at Vanderbilt (MCJCHV) provides specialized care for children and adolescents offering settings for patients to feel safe and supported while awaiting inpatient psychiatric care. Patients admitted to this team include children and adolescents with behavioral and psychological health challenges, including anxiety, depression, emotional distress, mood or personality disorders and many other mental health issues placing them at increased risk from harm from lethal means (sharps, medications, and firearms). Reducing immediate access to lethal means may mitigate the risk of fatal self-harm in youth. While likely beneficial in the inpatient setting, only one study exists examining the effects of an educational intervention for parents of hospitalized children.
To address this gap, we plan to implement a pilot intervention to offer secure storage counseling and device distribution to families of behavioral health patients who indicate firearm ownership on initial screening. The primary goal of this project is to determine the utilization and feasibility of providing these tools in the inpatient setting. We will additionally be assessing the feasibility of recruiting and retaining participants as well as the acceptability offering secure storage counseling in our study population to help inform future studies.
This will be a single arm observational pilot study. Participants will be asked to complete a pre- and post-survey via REDCap. Participants will first complete a self-guided pre-survey including demographic questions and current behaviors for medication and firearm storage. There will then be a 5-minute injury prevention educational session (lethal means counseling which is an underperformed standard of care for patients admitted with behavioral or mental health needs) informed by current evidence. The participants will also complete an online self-guided follow-up survey 1 month following the educational training. A REDCap link will be sent to the participant via email. Reminders will be sent at 1,2, and 7 days. Participants will be compensated for their participation.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Monroe Carell Jr Children's Hospital at Vanderbilt
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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:
- Guardian of child ages 0-18 years old who is admitted to and receiving care on the MCJCHV Behavioral Health Team
- Guardian age > or = 18 years
- Guardian with phone access to receive calls or email access to receive study information electronically
- English or Spanish-speaking guardian
- Guardian self-identifies as firearm owner
Exclusion Criteria:
- Guardian of children outside the specified age range
- Guardian speaks a language that is not English or Spanish
- Lack of telephone or email contact
- Guardian age is outside of the specific age range
- Guardians/children who do not otherwise meet the eligibility criteria listed in section above as determined by pre-screen
- Guardian or child in distress at time of enrollment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Counseling + Lock provision
Guardians of patients admitted to the behavioral health team who identify as firearm owners will be provided lethal means counseling and offered up to 3 secure storage devices of their choosing. |
Guardians of patients admitted to the Pediatric Hospital Medicine behavioral health team will be provided a brief lethal means educational session and offered up to 3 secure storage devices of their choosing (lock box and or cable locks) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Secure Storage Device Uptake
Periodo de tiempo: 1 day (Assessed at Initial survey)
|
The proportion of eligible families who take at least 1 storage device (cable locks or lock boxes). The numerator is defined as the number of guardians who take a firearm secure storage device when offered and the denominator is defined as the number of families included in the study. |
1 day (Assessed at Initial survey)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Secure Storage Device Usage
Periodo de tiempo: one month
|
The proportion of eligible families who self-report using the chosen device at time of 3-month follow up survey. This will be assessed via the survey question "Are you using any of the device(s) to lock a firearm?" with a dichotomous "Yes/No" response option. |
one month
|
|
Feasibility of follow up
Periodo de tiempo: one month
|
Feasibility of completing a follow up survey with parents within 1 month after the intervention measured by the proportion of guardian who complete the survey in its entirety either electronically or by phone. |
one month
|
|
Acceptability of intervention
Periodo de tiempo: one month
|
Acceptability will be measured using the Acceptability Intervention Measure, a 4-item instrument measuring the acceptability of an intervention on a 5-point Likert scale (Completely Disagree-Completely Agree). |
one month
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility of enrollment
Periodo de tiempo: Throughout the study, approximately one year
|
Feasibility of enrolling participants measured by the proportion of patient guardians approached who were enrolled. The numerator is defined as the number of guardians who are enrolled at the initial hospitalization. The denominator will be the total number of guardians approached. |
Throughout the study, approximately one year
|
|
Secure firearm storage
Periodo de tiempo: one month
|
Self-report at two time points based on the survey question, "To the best of your knowledge, are all the firearms where your child lives stored locked, unloaded and separate from ammunition?" |
one month
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kelsey Gastineau, Vanderbilt University Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 242424
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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