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NCT06485141 · ClinicalTrials.gov registry record · NA

BeSMART Secure Storage Counseling in the Inpatient Setting

A NA study of Safety Issues and Firearm Injury, sponsored by Vanderbilt University Medical Center.

Recruiting
Registry status
NA
Development phase
400
Enrollment target
2
Study locations

NCT06485141 is a NA study of Safety Issues and Firearm Injury that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 400 participants, above the 89-participant average among 13 other Safety Issues trials with a reported enrollment target (349% higher). The trial reports 2 study locations across 2 states.

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The verdict

NCT06485141, a NA study of Safety Issues and Firearm Injury, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.

RECRUITING
Registry status
NA
Development phase
400 participants
Enrollment target
2
Study locations

Study Summary

Firearm injuries are the leading cause of death for American youth. While most of these deaths are homicides, approximately one third are suicides and 5% are unintentional shootings where a child gains access to an unsecured firearm and unintentionally pulls the trigger injuring or killing themselves or someone else. Secure firearm storage in the home has been shown to significantly reduce the risk of both unintentional shootings and intentional self-harm behavior. Additionally, approximately 75% of the guns that show up on school grounds come from the homes of youth or their family members or friends. Despite evidence that secure storage counseling delivered in the pediatric outpatient setting significantly improves secure storage behavior AND recommendations from the American Academy of Pediatrics to provide secure storage counseling during well child checks, rates of counseling continue to be low. The Be SMART program is aligned with the American Academy of Pediatrics policy statement and recommendations and provides a scalable solution to efficient counseling in the clinical setting. However, except for one single site inpatient study, the efficacy of the Be SMART program has not been formally evaluated in the inpatient pediatric setting. By rigorously evaluating the efficacy of specific secure storage interventions like Be SMART the investigators can eventually improve counseling frequency with the goal of increasing gun safety behaviors and reducing firearm injuries and deaths in youth. The investigators hypothesize the Be SMART educational intervention, when delivered in the pediatric inpatient setting, will lead to significant improvement in the primary gun safety behavior endpoint and the secondary endpoint among both gun owners and non-gun owners when compared to control group.

Interventions

  • BEHAVIORAL Safe Storage Intervention
  • BEHAVIORAL Safe Kids Medication

Study Locations (2)

Colorado

  • Children's Hospital Colorado - Aurora

Tennessee

  • Monroe Carell Jr Children's Hospital at Vanderbilt - Nashville

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2025-09-20
Est. Completion 2026-09-30
Phase NA

What the Registry Record Tells You About NCT06485141

The ClinicalTrials.gov registry entry for NCT06485141 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 89-participant average among 13 other Safety Issues trials with a reported enrollment target (349% higher). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Safety Issues appearing as the primary indexed condition, and to 2 interventions - of which Safe Storage Intervention is the first listed.

NCT06485141 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Tennessee.

Frequently Asked Questions

What is clinical trial NCT06485141 about?

NCT06485141 is a clinical study titled "BeSMART Secure Storage Counseling in the Inpatient Setting". Firearm injuries are the leading cause of death for American youth. While most of these deaths are homicides, approximately one third are suicides and 5% are unintentional shootings where a child gains access to an unsecured firearm and unintentionally pulls the trigger injuring or killing themselve...

What is the current status of trial NCT06485141?

This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2025-09-20. Estimated completion is 2026-09-30.

What conditions does trial NCT06485141 study?

This clinical trial studies the following conditions: Safety Issues, Firearm Injury.

What interventions are being tested in trial NCT06485141?

The interventions under investigation include: Safe Storage Intervention (BEHAVIORAL), Safe Kids Medication (BEHAVIORAL).

Who is sponsoring clinical trial NCT06485141?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06485141 being conducted?

This trial has 2 study locations across Colorado, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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