NCT06485141 BeSMART Secure Storage Counseling in the Inpatient Setting
| NCT ID | NCT06485141 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Firearm Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-09-20 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-09-20 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Kelsey Gastineau, MD, MPH
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT06485141 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Firearm Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06485141 currently recruiting?
Yes, NCT06485141 is actively recruiting participants. Contact the research team at kelsey.gastineau@vumc.org for enrollment information.
Where is the NCT06485141 trial being conducted?
This trial is being conducted at Aurora, United States, Nashville, United States.
Who is sponsoring the NCT06485141 clinical trial?
NCT06485141 is sponsored by Vanderbilt University Medical Center. The principal investigator is Kelsey Gastineau, MD, MPH at Vanderbilt University Medical Center. The trial plans to enroll 400 participants.