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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Free safe firearm storage device distribution

Low cost safe firearm storage device

About this trial

This is an interventional prevention trial for Mental Health Disorders focused on measuring Injury prevention

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seattle Children's

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Baseline

Free Device

Low Cost Device

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of participants with all firearms safely secured

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

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

Description of participants who report storing fewer firearms in their homes during follow-up surveys compared to reported number of firearms at baseline

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

Description of participants who report using any safe firearm storage device at follow-up, change in any safe firearm storage device use from baseline

Full Information

NCT ID

NCT03386409

First Posted

December 21, 2017

Last Updated

May 3, 2022

Sponsor

Seattle Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03386409

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

February 12, 2016 (Actual)

Primary Completion Date

January 1, 2019 (Actual)

Study Completion Date

February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seattle Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Injury prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

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.

Masking

Participant

Masking Description

Participants are not informed about their group allocation.

Allocation

Randomized

Enrollment

255 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Baseline

Arm Type

No Intervention

Arm Description

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

Arm Title

Free Device

Arm Type

Experimental

Arm Description

Arm Title

Low Cost Device

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Free safe firearm storage device distribution

Intervention Description

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

Intervention Name(s)

Low cost safe firearm storage device

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

7 and 30 days post-enrollment

Secondary Outcome Measure Information:

Title

Proportion of participants with all firearms safely secured

Description

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

Time Frame

Baseline, 7 days and 30 days post-enrollment

Title

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

Description

Description of participants who report storing fewer firearms in their homes during follow-up surveys compared to reported number of firearms at baseline

Time Frame

Baseline, 7 days and 30 days post-enrollment

Title

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

Description

Description of participants who report using any safe firearm storage device at follow-up, change in any safe firearm storage device use from baseline

Time Frame

Baseline, 7 days and 30 days post-enrollment

10. Eligibility

Sex

All

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Neil Uspal, MD

Organizational Affiliation

Seattle Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seattle Children's

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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