NCT07482982

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
784

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

January 13, 2026

Last Update Submit

March 16, 2026

Conditions

Keywords

Firearm safetyFirearm injuryFirearm ownershipInjury preventionPediatric emergency department

Outcome Measures

Primary Outcomes (1)

  • Highest rate of report of firearm exposure.

    Per screener, which yielded the highest reported rate of firearm exposure

    Screener takes 10 minutes

Secondary Outcomes (1)

  • Rate of uptake of cable lock or lockbox 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.

Study Arms (6)

Standard Screening

EXPERIMENTAL

Caregivers who receive Screening Questionnaire 1

Other: Screening Questions 1

If Firearm how stored

EXPERIMENTAL

Caregivers who receive Screening Questionnaire 2

Other: Screening Questionnaire 2

Firearm in places where child spends time

EXPERIMENTAL

Caregivers who receive Screening Questionnaire 3

Other: Screening Questionnaire 3

Is there a firearm, how prevented from shooting accidentally

EXPERIMENTAL

Caregivers who receive Screening Questionnaire 4

Other: Screening Questionnaire 4

If firearm stored in lockbox, cable lock, unlocked

EXPERIMENTAL

Caregivers who receive Screening Questionnaire 5

Other: Screening Questionnaire 5

How are firearms stored anywhere your child spends time

EXPERIMENTAL

Caregivers who receive Screening Questionnaire 6

Other: Screening Questionnaire 6

Interventions

The arm asks caregiver about firearm possession and whether it is locked.

Standard Screening

Caregivers are asked modified questions about firearm possession and how firearm is stored.

If Firearm how stored

Caregivers are asked modified questions about firearm possession and how firearm is stored.

Firearm in places where child spends time

Caregivers are asked modified questions about firearm possession and how firearm is stored.

Is there a firearm, how prevented from shooting accidentally

Caregivers are asked modified questions about firearm possession and how firearm is stored.

If firearm stored in lockbox, cable lock, unlocked

Caregivers are asked modified questions about firearm possession and how firearm is stored.

How are firearms stored anywhere your child spends time

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Under age 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Minnesota

Minneapolis, Minnesota, 55405, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking Description
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Model Description
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ED Staff Physician

Study Record Dates

First Submitted

January 13, 2026

First Posted

March 19, 2026

Study Start

December 15, 2024

Primary Completion

September 4, 2025

Study Completion

September 4, 2025

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

De-identified results may be shared with other researchers who contact the study PI requesting said data.

Shared Documents
SAP, CSR, ANALYTIC CODE
Time Frame
Will be available from the time of manuscript publication (still awaiting submission), for 2 years.
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.

Locations