Recruiting

Be SMART

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06485141

Conditions

Firearm Injury

Safety Issues

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Safe Storage Intervention

Safe Kids Medication

Study Details

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

Study ID

NCT06485141

Start date

Sep 20, 2025

Status verified date

May, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria (must meet ALL):

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

Exclusion Criteria:

1. Caregivers of children admitted for firearm injury
2. Caregivers of children with a firearm injury within the last 3 months
3. Caregivers of children admitted with a primary psychiatric diagnosis including suicidal ideation, self-harm, homicidal ideation, aggression, or intentional ingestion
4. 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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Safe Storage Intervention

Firearm storage information and secure storage device.

Safe Kids Medication

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.

Primary outcome measure

  • Secure firearm storage among gun owners [ Time Frame: 1 month ]
  • Asking about firearm storage among all participants [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Justine Stassun, MS

justine.c.stassun@vumc.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Monroe Carell Jr Children's Hospital at Vanderbilt

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-05-11.