Firearm SafetyNCT07482982
Firearm Screening in the Pediatric Emergency Department
A study testing Screening Questions 1, Screening Questionnaire 2 and Screening Questionnaire 3 in people with Firearm Safety and Firearm Injury, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Firearm Safety, Firearm Injury, Firearm Ownership
- What is being tested?
- Screening Questions 1, Screening Questionnaire 2 and Screening Questionnaire 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 784 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2024to 4 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under age 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Firearm Safety, Firearm Injury, Firearm Ownership
- Being tested
- Screening Questions 1, Screening Questionnaire 2, Screening Questionnaire 3, Screening Questionnaire 4, Screening Questionnaire 5
- Keywords
- Firearm safety, Firearm injury, Firearm ownership, Injury prevention, Pediatric emergency department
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening Questions 1Other
The arm asks caregiver about firearm possession and whether it is locked.
Screening Questionnaire 2Other
Caregivers are asked modified questions about firearm possession and how firearm is stored.
Screening Questionnaire 3Other
Caregivers are asked modified questions about firearm possession and how firearm is stored.
Screening Questionnaire 4Other
Caregivers are asked modified questions about firearm possession and how firearm is stored.
Screening Questionnaire 5Other
Caregivers are asked modified questions about firearm possession and how firearm is stored.
Screening Questionnaire 6Other
Caregivers are asked modified questions about firearm possession and how firearm is stored.
| Study group | Role | What they receive |
|---|---|---|
| Standard Screening | Experimental | Caregivers who receive Screening Questionnaire 1 Receives: Other: Screening Questions 1 |
| If Firearm how stored | Experimental | Caregivers who receive Screening Questionnaire 2 Receives: Other: Screening Questionnaire 2 |
| Firearm in places where child spends time | Experimental | Caregivers who receive Screening Questionnaire 3 Receives: Other: Screening Questionnaire 3 |
| Is there a firearm, how prevented from shooting accidentally | Experimental | Caregivers who receive Screening Questionnaire 4 Receives: Other: Screening Questionnaire 4 |
| If firearm stored in lockbox, cable lock, unlocked | Experimental | Caregivers who receive Screening Questionnaire 5 Receives: Other: Screening Questionnaire 5 |
| How are firearms stored anywhere your child spends time | Experimental | Caregivers who receive Screening Questionnaire 6 Receives: Other: Screening Questionnaire 6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highest rate of report of firearm exposure.
Per screener, which yielded the highest reported rate of firearm exposure
Measured: Screener takes 10 minutes
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start15 Dec 2024
- Primary completion4 Sep 2025
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Firearm SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 784 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Weigert, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482982
- Sponsor's protocol ID
- 2024-100
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified results may be shared with other researchers who contact the study PI requesting said data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Firearm Screening in the Pediatric Emergency Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07482982
- Acronym / sponsor ID
- 2024-100
- Conditions
- Firearm Safety, Firearm Injury, Firearm Ownership
- Keywords
- Firearm safety, Firearm injury, Firearm ownership, Injury prevention, Pediatric emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 784 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Standard Screening | Experimental | Other: Screening Questions 1Caregivers who receive Screening Questionnaire 1 |
| If Firearm how stored | Experimental | Other: Screening Questionnaire 2Caregivers who receive Screening Questionnaire 2 |
| Firearm in places where child spends time | Experimental | Other: Screening Questionnaire 3Caregivers who receive Screening Questionnaire 3 |
| Is there a firearm, how prevented from shooting accidentally | Experimental | Other: Screening Questionnaire 4Caregivers who receive Screening Questionnaire 4 |
| If firearm stored in lockbox, cable lock, unlocked | Experimental | Other: Screening Questionnaire 5Caregivers who receive Screening Questionnaire 5 |
| How are firearms stored anywhere your child spends time | Experimental | Other: Screening Questionnaire 6Caregivers who receive Screening Questionnaire 6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Under age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening Questions 1The arm asks caregiver about firearm possession and whether it is locked. | Other | Standard Screening |
| Screening Questionnaire 2Caregivers are asked modified questions about firearm possession and how firearm is stored. | Other | If Firearm how stored |
| Screening Questionnaire 3Caregivers are asked modified questions about firearm possession and how firearm is stored. | Other | Firearm in places where child spends time |
| Screening Questionnaire 4Caregivers are asked modified questions about firearm possession and how firearm is stored. | Other | Is there a firearm, how prevented from shooting accidentally |
| Screening Questionnaire 5Caregivers are asked modified questions about firearm possession and how firearm is stored. | Other | If firearm stored in lockbox, cable lock, unlocked |
| Screening Questionnaire 6Caregivers are asked modified questions about firearm possession and how firearm is stored. | Other | How are firearms stored anywhere your child spends time |
Primary outcome
Highest rate of report of firearm exposure.
Time frame: Screener takes 10 minutes
Per screener, which yielded the highest reported rate of firearm exposure
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified results may be shared with other researchers who contact the study PI requesting said data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening Questions 1, Screening Questionnaire 2 and Screening Questionnaire 3 in people with Firearm Safety and Firearm Injury, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highest rate of report of firearm exposure. (time frame: Screener takes 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.