Firearm Screening in the Pediatric Emergency Department

March 16, 2026 updated by: Rachel Weigert, Children's Hospitals and Clinics of Minnesota

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
784

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Highest rate of report of firearm exposure.
Time Frame: Screener takes 10 minutes
Per screener, which yielded the highest reported rate of firearm exposure
Screener takes 10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of uptake of cable lock or lockbox in those reporting firearm exposure
Time Frame: 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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospitals and Clinics of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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