NCT06485141 · Vanderbilt University Medical Center
BeSMART Secure Storage Counseling in the Inpatient Setting
(BeSMART)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Safe Storage Intervention
Firearm storage information and secure storage device.
BEHAVIORAL
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 measures
Secure firearm storage among gun owners
Time frame: 1 month
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.
Asking about firearm storage among all participants
Time frame: 1 month
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (must meet ALL):
- 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)
Exclusion criteria
- 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.
Where
- Aurora, Colorado
- Nashville, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations