Be SMART secure firearm storage counseling for hospitalized caregivers
BeSMART Secure Storage Counseling in the Inpatient Setting
This program will test whether a short Be SMART video and handout help caregivers of hospitalized children store firearms more safely at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT06485141 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled trial enrolling 300 caregivers (150 per arm) at two pediatric hospitals to compare the Be SMART secure-storage intervention to a control education intervention about medication storage. After informed consent and a baseline survey, participants are randomized 1:1 and the intervention is delivered on a tablet with a postcard-sized handout; follow-up assessments are conducted using email and telephone. Enrollment is monitored to ensure at least one-third of participants are gun owners, with enrollment pauses for non-gun owners to maintain that distribution. The trial focuses on caregivers of children admitted to hospital medicine services and excludes caregivers of children admitted for firearm injuries or primary psychiatric diagnoses.
Who should consider this trial
Good fit: Caregivers (English- or Spanish-speaking) of children aged 0–17 hospitalized on a pediatric hospital medicine service who can provide informed consent and have email and telephone access are ideal candidates.
Not a fit: Caregivers of children admitted for firearm injury or with a recent firearm injury, those with a primary psychiatric admission or surgical co-management, non-English/Spanish speakers, or those without email/phone access are excluded and unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could increase safe firearm storage in homes and help reduce unintentional shootings and youth self-harm related to unsecured guns.
How similar studies have performed: Outpatient secure-storage counseling has previously increased safe storage practices, but applying the Be SMART program in the inpatient setting is a relatively novel adaptation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aurora, Colorado and 1 other locations
- Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
- Monroe Carell Jr Children's Hospital at Vanderbilt — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Kelsey Gastineau, MD, MPH — Vanderbilt University Medical Center
- Study coordinator: Kelsey Gastineau, MD, MPH
- Email: kelsey.gastineau@vumc.org
- Phone: 615-936-7276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.