BeSMART Secure Storage Counseling in the Inpatient Setting

NCT06485141 | Recruiting

• 1 other identifier: 241305
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Firearm Injury; Safety Issues

Outcome Measures

Primary Outcomes (2)

• Secure firearm storage among gun owners

  Self-reported secure storage behavior will be the primary endpoint for gun-owners in the sample. Participants will respond to the survey question of "Please share how the majority (meaning more than half) of the guns (such as pistols, revolvers, shotguns, and rifles) in your home/vehicles are stored." with an ordinal scale of storage (Locked and Unloaded, Locked and Loaded, Unlocked and Unloaded, and Unlocked and Loaded) in decreasing order of safety. Responses will be analyzed comparing Locked and Unloaded to the other three choices for a dichotomous measure.

  1 month

• Asking about firearm storage among all participants

  Self- report based on the survey question "How often do you ask about the presence of firearms in homes where your child(ren) visits?". Response to the survey question is a Likert scale asking frequency (Never-Rarely - Sometimes - Always - Often).

  1 month

Secondary Outcomes (1)

• Asking about firearm storage among all participants

  3 months

Other Outcomes (3)

• Firearm Storage Knowledge

  1 month and 3 months

• Secure firearm storage among gun owners

  3 months

• Locking behavior

  1 month and 3 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Guardians of hospitalized children in the active comparator group will view a brief medication storage safety video produced by Safe Kids.

Behavioral: Safe Kids Medication

Intervention

EXPERIMENTAL

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.

Behavioral: Safe Storage Intervention

Interventions

Safe Storage Intervention BEHAVIORAL

Firearm storage information and secure storage device.

Intervention

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Caregiver of child hospitalized on a pediatric hospital medicine service aged 0-17
• English or Spanish speaking caregiver
• Access to necessary resources for participating in a technology-based intervention follow-up assessments (e-mail and telephone)

You may not qualify if:

• Caregivers of children admitted for firearm injury
• Caregivers of children with a firearm injury within the last 3 months
• Caregivers of children admitted with a primary psychiatric diagnosis including suicidal ideation, self-harm, homicidal ideation, aggression, or intentional ingestion
• Caregivers of children who are admitted to a surgical co-management team
• Non-gun owners will be excluded intermittently throughout the enrollment period based on proportion of gun owners enrolled. For every 30 study participants enrolled, 10 must be gun owners. Non-gun owner enrollment will be paused until 10 gun owners are enrolled and this cycle will repeat for every 30 participants enrolled at each study site.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (2)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

RECRUITING

Study Officials

• Kelsey Gastineau, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey Gastineau, MD, MPH

CONTACT

615-936-7276; kelsey.gastineau@vumc.org

Justine Stassun, MS

CONTACT

justine.c.stassun@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: July 3, 2024
• Study Start: September 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)