- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06479889
Un stockage plus sûr Des maisons plus sûres Un essai pilote de conseil sur les moyens mortels chez les enfants hospitalisés
Stockage plus sûr Des maisons plus sûres : enquête sur l'utilisation de dispositifs de stockage sécurisé dans la population hospitalisée en santé comportementale
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Tennessee
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Nashville, Tennessee, États-Unis, 37232
- Monroe Carell Jr Children's Hospital at Vanderbilt
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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) |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Secure Storage Device Uptake
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Secure Storage Device Usage
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility of enrollment
Délai: 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
|
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Secure firearm storage
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Kelsey Gastineau, Vanderbilt University Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 242424
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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