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Firearm Storage Device Distribution to Families of Children With Mental Health Complaints

3 maggio 2022 aggiornato da: Neil Uspal, Seattle Children's Hospital

Impact of Firearm Safety Device Distribution on Firearm Exposure in the Households of Patients With Mental Health Complaints

This study aims to describe the baseline rate of safe firearm storage device use in the homes of pediatric patients with mental health complaints treated in the Emergency Department (ED) and/or inpatient psychiatric unit of an urban tertiary pediatric hospital.

Follow-up data will be collected to ascertain any change(s) in the rate of safe firearm storage device use after patients have been treated for a mental health complaint, which includes standardized recommendations for safe firearm storage practices. This study also involves an intervention to distribute safe firearm storage devices to families of pediatric mental health patients during their hospital visit, and assesses whether safe storage device distribution impacts reported future rate of firearm safety device use.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Firearm injuries are a significant cause of morbidity and mortality for children and teens. Access to firearms has been associated with suicide completion in the pediatric mental health population. Current practice in our pediatric Emergency Department (ED) and inpatient psychiatric unit is to screen all mental health patients for firearm access, and to recommend safe firearm storage practices. However, there is no data on the baseline rate of safe firearm storage device use in the homes of these patients, or on the effectiveness of providing these recommendations during hospitalization.

This study has two phases, a baseline and an intervention. During the baseline phase, the research team will study whether there is an improvement in safe firearm storage device use in the homes of participants 7 or 30 days after safe storage practices are recommended during an ED or inpatient psychiatric visit. During the intervention phase, in addition to the standard recommendation of safe storage practices during the visit, the research team will distribute firearm safety storage devices such as a lock box, trigger lock, and and/or cable lock to families at the time of study enrollment. The investigators will study whether there is an improvement in safe firearm storage device use in the homes of intervention participants after 7 or 30 days compared to the usual care group.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

255

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Washington
      • Seattle, Washington, Stati Uniti, 98105
        • Seattle Children's

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Age 0-17 years, inclusive
  • Evaluated in the Emergency Department or inpatient psychiatric unit for a primary mental health complaint
  • Presence of a firearm in household where patient resides at least one day per week and/or will reside for at least one of the 7 days following enrollment
  • Accompanied by a parent or legal guardian
  • Parent or legal guardian is proficient in English
  • Parent or legal guardian is 18 years of age or older

Exclusion Criteria:

  • Patient is 18 years of age or older
  • Patient is not evaluated for a mental health complaint in the Emergency Department or inpatient psychiatric unit
  • The adult participant has previously enrolled in the intervention phase of the study.
  • Patient is accompanied by a parent/legal guardian who has previously enrolled a different child in the intervention phase of the study
  • Patient is not accompanied by a parent or legal guardian during their PMBU or ED visit
  • Parent or legal guardian accompanying patient does not reside and/or does not anticipate residing in the household with patient for any of the 7 days following enrollment and no other adult household member is present to consent Note: Adult household members may only consent to participate in this study if a parent or legal guardian is also present to provide informed consent.

For adult household members only:

Inclusion Criteria:

  • 18 years of age or older
  • Lives in same household as patient at least one day per week
  • Has primary or shared responsibility for at least one firearm stored in the household
  • Proficient in English

Exclusion Criteria:

  • Resides in household with patient less than one day per week, and/or does not anticipate residing in the household with patient for any of the 7 days following enrollment
  • Is not responsible for firearm storage in the home

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Baseline
Participants receive the standard of care recommendations for safe firearm storage device usage.
Sperimentale: Free Device
Participants receive the standard of care recommendations for safe firearm storage device usage In addition, the study intervention is provision of a free safe firearm storage device (lock box, trigger lock and/or cable lock) for firearm storage at the time of enrollment.
Comportamentale: Free safe firearm storage device distribution
Participants in the experimental phase of the study receive a safe firearm storage device at the time of study enrollment. They are randomized to receive a free device. Safe firearm storage devices include a California Department of Justice-approved lock box, trigger lock and/or cable lock.
Sperimentale: Low Cost Device
Participants receive the standard of care recommendations for safe firearm storage device usage. In addition, the study intervention is the provision of a low cost ($5) firearm storage device (lock box, trigger lock and/or cable lock) for firearm storage at the time of enrollment.
Comportamentale: Low cost safe firearm storage device
Participants in the experimental phase of the study receive a safe firearm storage device at the time of study enrollment. They are randomized to receive a low cost ($5) device. Safe firearm storage devices include a California Department of Justice-approved lock box, trigger lock and/or cable lock.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in the number of unsecured firearms stored in the household.
Lasso di tempo: 7 and 30 days post-enrollment
Comparison in the participant-reported number of unsecured firearms stored in their household at the time of enrollment, 7 days post-enrollment, and 30 days post-enrollment.
7 and 30 days post-enrollment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of participants with all firearms safely secured
Lasso di tempo: Baseline, 7 days and 30 days post-enrollment
Description of participants with all firearms secured using "triple safe" storage methods: firearms stored in a locked location, unloaded, and with ammunition stored in a separate, locked location
Baseline, 7 days and 30 days post-enrollment
Proportion of participants who report storing fewer firearms in their homes at follow-up
Lasso di tempo: Baseline, 7 days and 30 days post-enrollment
Description of participants who report storing fewer firearms in their homes during follow-up surveys compared to reported number of firearms at baseline
Baseline, 7 days and 30 days post-enrollment
Proportion of participants who report using a firearm safety storage device at follow-up
Lasso di tempo: Baseline, 7 days and 30 days post-enrollment
Description of participants who report using any safe firearm storage device at follow-up, change in any safe firearm storage device use from baseline
Baseline, 7 days and 30 days post-enrollment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Seattle Children's Hospital

Investigatori

  • Investigatore principale: Neil Uspal, MD, Seattle Children's Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 febbraio 2016

Completamento primario (Effettivo)

1 gennaio 2019

Completamento dello studio (Effettivo)

1 febbraio 2019

Date di iscrizione allo studio

Primo inviato

21 dicembre 2017

Primo inviato che soddisfa i criteri di controllo qualità

21 dicembre 2017

Primo Inserito (Effettivo)

29 dicembre 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 maggio 2022

Ultimo verificato

1 maggio 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 00000009

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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