Be SMART Intervention for Safety Concerns

(BeSMART Trial)

Recruiting at 1 trial location

Overseen By Kelsey Gastineau, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Firearm injury, Psychiatric diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the Be SMART educational program in promoting safe gun storage among families of hospitalized children. By teaching caregivers about secure firearm storage, the trial seeks to reduce accidental gun injuries and improve safety behaviors. Participants include English or Spanish-speaking caregivers of children hospitalized for non-firearm-related conditions, with access to email and a phone. The trial compares families who receive the Be SMART video and a free gun lock to those who watch a medication safety video.

As an unphased trial, this study offers caregivers the opportunity to actively contribute to enhancing child safety and preventing accidental injuries.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on educational interventions rather than medication changes.

What prior data suggests that the Be SMART Secure Storage Counseling is safe?

Research has shown that safely storing guns can greatly reduce the risk of gun-related injuries and deaths among children. The Be SMART program promotes these safety practices by encouraging people to secure guns, set a good example, and inquire about unsecured guns in other homes.

The program aims to improve gun safety habits through education and follows the recommendations of the American Academy of Pediatrics. As an educational program, it poses no physical risk to participants. A previous study of the Be SMART program found no negative effects, indicating it is well-tolerated. This makes the program a safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BeSMART Secure Storage Counseling because it takes a fresh approach to promoting safety in homes with children. Unlike traditional safety videos, this intervention combines a short educational video on secure firearm storage with a practical tool—a cable gun lock—provided to families. This dual approach not only raises awareness but also offers a tangible solution to improve safety, which could potentially reduce the risk of firearm-related accidents in households. By directly addressing secure storage practices, the intervention aims to foster real behavioral change, which is a promising step forward in enhancing child safety.

What evidence suggests that the Be SMART program is effective for improving gun safety behaviors?

Research has shown that storing guns safely, as recommended by the Be SMART program, significantly reduces accidental shootings and suicides among young people. Studies have found that when doctors discuss safe gun storage with families, it encourages safer storage practices. In this trial, guardians of hospitalized children in the intervention group will receive the Be SMART program, which instructs families to keep guns unloaded, locked, and separate from ammunition. This aligns with previous findings. By providing advice and tools like gun locks, the program aims to make homes safer for children. Although hospital data is limited, early results show promise in reducing gun-related injuries and deaths. ^{1 2 3 6 7}

Who Is on the Research Team?

Kelsey Gastineau, MD, MPH

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for caregivers of children aged 0-17 hospitalized on a pediatric service, who can consent to participate and communicate in English or Spanish. They must have email and phone access for follow-up. It's not specified who cannot join.

Inclusion Criteria

I have signed and dated the consent form.

I have access to email and a phone for follow-up.

I am the caregiver of a child aged 0-17 hospitalized in pediatric care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Enrollment and Baseline

Informed consent is obtained, randomization occurs, and baseline survey is administered

1 day

1 visit (in-person)

Intervention

Participants receive either the Be SMART intervention or control intervention, followed by an immediate post-intervention survey

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in firearm storage behavior and knowledge through electronic surveys

3 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• BeSMART Secure Storage Counseling

Trial Overview

The Be SMART program, which provides secure firearm storage counseling, is being tested in the hospital setting to see if it improves gun safety behaviors among caregivers to reduce youth firearm injuries and deaths.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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.

Group II: Control Active Control 1 Intervention

Guardians of hospitalized children in the active comparator group will view a brief medication storage safety video produced by Safe Kids.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1.

besmartforkids.org

besmartforkids.org/secure-gun-storage/resources/

Gun Safety Resources

Use these resources to learn more about the Be SMART campaign and how you can help spread the Be SMART message of secure firearm storage.

2.

besmartforkids.org

besmartforkids.org/

Be SMART | Secure Gun Storage

Be SMART raises awareness that secure gun storage — storing guns locked, unloaded and separate from ammunition — can save children's lives.

3.

besmartforkids.org

besmartforkids.org/wp-content/uploads/2014/09/BeSmart-Secure-Storage-Fact-Sheet-012521A-1.pdf

UNLOAD, LOCK, AND SEPARATE: SECURE STORAGE ...

The bottom line is this: Storing firearms unloaded, locked, and separate from ammunition prevents access and saves lives. What is secure firearm storage?

4.

publications.aap.org

publications.aap.org/hospitalpediatrics/article/11/7/691/179857/A-Randomized-Controlled-Trial-for-Parents-of

A Randomized Controlled Trial for Parents of Hospitalized ...

Office-based studies combining counseling with provision of a firearm safety device revealed success in improving safe gun storage.6–8 ...

5.

annemergmed.com

annemergmed.com/article/S0196-0644(23)00215-9/fulltext

Acceptability of Long Versus Short Firearm Safety ...

Safe firearm storage is protective against pediatric firearm injuries. We sought to compare a 3-minute versus 30-second safe firearm storage ...

6.

news.vumc.org

news.vumc.org/2025/08/27/be-smart-campaign-highlights-efforts-to-reduce-firearm-incidents-involving-children/

Be SMART campaign highlights efforts to reduce firearm ...

“Secure firearm storage is an evidence-based solution to reduce unintentional injuries, firearm-related suicide, and firearm homicides among ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03077646

NCT03077646 | Pediatric Inpatient Firearm Safety Study

The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen ...