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

NCT03386409 | Completed

• 1 other identifier: 00000009
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health Disorders; Suicide or Selfinflicted Injury by Firearms and Explosives

Keywords

Injury prevention

Outcome Measures

Primary Outcomes (1)

• Change in the number of unsecured firearms stored in the household.

  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

Secondary Outcomes (3)

• Proportion of participants with all firearms safely secured

  Baseline, 7 days and 30 days post-enrollment

• Proportion of participants who report storing fewer firearms in their homes at follow-up

  Baseline, 7 days and 30 days post-enrollment

• Proportion of participants who report using a firearm safety storage device at follow-up

  Baseline, 7 days and 30 days post-enrollment

Study Arms (3)

Baseline

NO INTERVENTION

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

Free Device

EXPERIMENTAL

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.

Behavioral: Free safe firearm storage device distribution

Low Cost Device

EXPERIMENTAL

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.

Behavioral: Low cost safe firearm storage device

Interventions

Free safe firearm storage device distribution 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.

Free Device

Low cost safe firearm storage device 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.

Low Cost Device

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Neil Uspal, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not informed about their group allocation.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: December 29, 2017
• Study Start: February 12, 2016
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2019
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)