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

3. maj 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

255

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98105
        • Seattle Children's

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Baseline
Participants receive the standard of care recommendations for safe firearm storage device usage.
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the number of unsecured firearms stored in the household.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants with all firearms safely secured
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seattle Children's Hospital

Efterforskere

  • Ledende efterforsker: Neil Uspal, MD, Seattle Children's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. februar 2016

Primær færdiggørelse (Faktiske)

1. januar 2019

Studieafslutning (Faktiske)

1. februar 2019

Datoer for studieregistrering

Først indsendt

21. december 2017

Først indsendt, der opfyldte QC-kriterier

21. december 2017

Først opslået (Faktiske)

29. december 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 00000009

Plan for individuelle deltagerdata (IPD)

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