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

NCT ID: NCT03386409

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-12

Study Completion Date

2019-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mental Health Disorders Suicide or Selfinflicted Injury by Firearms and Explosives

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

In the first phase of the study, all participants are assigned to an observational baseline group. Once the enrollment milestone is met, the second phase of the study will open. In this phase, participants all receive the intervention of safe firearm storage device distribution. Participants are randomized to either the free device group, or the low cost ($5) device group.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Participants are not informed about their group allocation.

Study Groups

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Baseline

Participants receive the standard of care recommendations for safe firearm storage device usage.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Free safe firearm storage device distribution

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Low cost safe firearm storage device

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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

* 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:


* 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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Neil Uspal

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neil Uspal, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

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Seattle Children's

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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00000009

Identifier Type: -

Identifier Source: org_study_id

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