BeSMART Secure Storage Counseling in the Inpatient Setting

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06485141
Status
Recruiting

Conditions

  • Firearm Injury
  • Safety Issues

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Safe Storage Intervention — BEHAVIORAL
    Firearm storage information and secure storage device.
  • Safe Kids Medication — BEHAVIORAL
    The Control participants will view a brief medication storage safety video produced by Safe Kids. A Frequently Asked Questions handout on medication safety created by Safe Kids will be available for parents as well.

Study Details

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.

Key Dates

Start date
Sep 20, 2025
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Control
    Guardians of hospitalized children in the active comparator group will view a brief medication storage safety video produced by Safe Kids.
  • Experimental: Intervention
    Guardians of hospitalized children will receive the study intervention, viewing a 3 minute educational video about the importance of secure firearm storage from the Be SMART program. Additionally, a cable gun lock will be offered to families in the intervention group along with a Frequently Asked Questions handout from Be SMART.

Primary Outcome Measure

Secure firearm storage among gun owners [ Time Frame: 1 month ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Kilinsky
720-777-8335
Monroe Carell Jr Children's Hospital at VanderbiltNashvilleTennessee37232
Gastineau
615-875-9763

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