Firearm Screening in the Pediatric Emergency Department

Firearm Screening in the Pediatric Emergency Department: A Randomized Controlled Trial

Firearm injuries is the leading cause of death for children in the United States with approximately 5,000 children being injured or killed by firearms annually. Estimates show there are over 400 million legal and illicit firearms in the US, with approximately 43% of Minnesotans owning a firearm, and over 4.5 million US children living in a home where a firearm is stored loaded and unlocked. Due to the ubiquity of firearms in American homes, interventions that address safe storage can prevent a significant number of pediatric injuries and deaths. Injury prevention and safety counseling are integral parts of pediatric care. Pediatric providers already screen for and provide safety counseling regarding infant sleep location, car seats, bike helmets, and smoking. Firearm safety screening is a natural fit with pediatric practice. However, in the absence of a standardized process, screening for firearm access is rarely completed. In this randomized controlled trial (RCT), the investigators will identify the most effective firearm safety screening question(s) among caregivers of children presenting to the pediatric emergency department (PED) using a stratified, six-arm RCT. Under the assumption that individuals under-report firearm ownership, firearm safety screeners resulting in higher rates of self-reported firearm exposure will be considered more effective.

Study Overview

• Status: Completed
• Conditions: Firearm Injury; Firearm Safety; Firearm Ownership
• Intervention / Treatment: Other: Screening Questions 1; Other: Screening Questionnaire 2; Other: Screening Questionnaire 3; Other: Screening Questionnaire 4; Other: Screening Questionnaire 5; Other: Screening Questionnaire 6

• Study Type: Interventional
• Enrollment (Actual): 784
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55405
      • Children's Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Caregivers: Any adult in the PED may self-enroll through use of the QR code.
• Research Assistants will only approach families to facilitate enrollment for: 1) Emergency Severity Index (ESI) 3, 4, or 5; 2) ESI 1 or 2 with provider approval; 3) Families who are noted to speak English, Spanish, or Somali in Cerner

Exclusion Criteria:

• Under age 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Screening; Caregivers who receive Screening Questionnaire 1	Other: Screening Questions 1; The arm asks caregiver about firearm possession and whether it is locked.
Experimental: If Firearm how stored; Caregivers who receive Screening Questionnaire 2	Other: Screening Questionnaire 2; Caregivers are asked modified questions about firearm possession and how firearm is stored.
Experimental: Firearm in places where child spends time; Caregivers who receive Screening Questionnaire 3	Other: Screening Questionnaire 3; Caregivers are asked modified questions about firearm possession and how firearm is stored.
Experimental: Is there a firearm, how prevented from shooting accidentally; Caregivers who receive Screening Questionnaire 4	Other: Screening Questionnaire 4; Caregivers are asked modified questions about firearm possession and how firearm is stored.
Experimental: If firearm stored in lockbox, cable lock, unlocked; Caregivers who receive Screening Questionnaire 5	Other: Screening Questionnaire 5; Caregivers are asked modified questions about firearm possession and how firearm is stored.
Experimental: How are firearms stored anywhere your child spends time; Caregivers who receive Screening Questionnaire 6	Other: Screening Questionnaire 6; Caregivers are asked modified questions about firearm possession and how firearm is stored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Highest rate of report of firearm exposure.	Per screener, which yielded the highest reported rate of firearm exposure	Screener takes 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of uptake of cable lock or lockbox in those reporting firearm exposure	For each screening, a "positive" exposure to firearms was determined. These individuals were offered a lockbox and all participants were offered a cable lock. The secondary outcome specifically assessed the rate of uptake of the locking devices in those reporting firearm exposure.	Each participant completed a one time survey in the ED. There was no extended enrollment or follow up. The survey took approximately 10 minutes to complete.

Collaborators and Investigators

• Sponsor: Children's Hospitals and Clinics of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Actual): September 4, 2025
• Study Completion (Actual): September 4, 2025

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Injury prevention; Pediatric emergency department; Firearm safety; Firearm injury; Firearm ownership
• Other Study ID Numbers: 2024-100 (Comité Etico Cientifico Facultad de Medicina Universidad del Desarrollo Clínica Alemana)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified results may be shared with other researchers who contact the study PI requesting said data.
• IPD Sharing Time Frame: Will be available from the time of manuscript publication (still awaiting submission), for 2 years.
• IPD Sharing Access Criteria: IPD and supporting information may be accessed by emailing the study PI and requesting this information. This will be shared via encrypted email.
• IPD Sharing Supporting Information Type: SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No