Be SMART secure firearm storage counseling for hospitalized caregivers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.