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

3 mei 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

255

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Washington
      • Seattle, Washington, Verenigde Staten, 98105
        • Seattle Children's

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Niet ouder dan 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Baseline
Participants receive the standard of care recommendations for safe firearm storage device usage.
Experimenteel: 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.
Gedragsmatig: 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.
Experimenteel: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in the number of unsecured firearms stored in the household.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants with all firearms safely secured
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Seattle Children's Hospital

Onderzoekers

  • Hoofdonderzoeker: Neil Uspal, MD, Seattle Children's Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 februari 2016

Primaire voltooiing (Werkelijk)

1 januari 2019

Studie voltooiing (Werkelijk)

1 februari 2019

Studieregistratiedata

Eerst ingediend

21 december 2017

Eerst ingediend dat voldeed aan de QC-criteria

21 december 2017

Eerst geplaatst (Werkelijk)

29 december 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 mei 2022

Laatste update ingediend die voldeed aan QC-criteria

3 mei 2022

Laatst geverifieerd

1 mei 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 00000009

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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