An interventional study of Screening Questions 1 and Screening Questionnaire 2 in Firearm Safety, Firearm Injury and Firearm Ownership, sponsored by Children's Hospitals and Clinics of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Children's Hospitals and Clinics of Minnesota · Not applicable, Interventional, and Screening
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.
Children's Hospitals and Clinics of Minnesota is the lead sponsor of 49 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Caregivers who receive Screening Questionnaire 1
Other: Screening Questions 1
Caregivers who receive Screening Questionnaire 2
Other: Screening Questionnaire 2
Caregivers who receive Screening Questionnaire 3
Other: Screening Questionnaire 3
Caregivers who receive Screening Questionnaire 4
Other: Screening Questionnaire 4
Caregivers who receive Screening Questionnaire 5
Other: Screening Questionnaire 5
Caregivers who receive Screening Questionnaire 6
Other: Screening Questionnaire 6
The arm asks caregiver about firearm possession and whether it is locked.
Caregivers are asked modified questions about firearm possession and how firearm is stored.
Caregivers are asked modified questions about firearm possession and how firearm is stored.
Caregivers are asked modified questions about firearm possession and how firearm is stored.
Caregivers are asked modified questions about firearm possession and how firearm is stored.
Caregivers are asked modified questions about firearm possession and how firearm is stored.
Highest rate of report of firearm exposure.
Per screener, which yielded the highest reported rate of firearm exposure
Time frame: Screener takes 10 minutes
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.
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.
Plan to share: Yes — De-identified results may be shared with other researchers who contact the study PI requesting said data.
Supporting information: Statistical analysis plan, Clinical study report, 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.
No publications or documents are linked to this record.
Ran from Dec 2024 to primary completion in Sep 2025, 8 months.
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Children's Hospitals and Clinics of Minnesota