BeSMART Secure Storage Counseling in the Inpatient Setting (BeSMART)

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.

Study Overview

• Status: Recruiting
• Conditions: Safety Issues; Firearm Injury
• Intervention / Treatment: Behavioral: Safe Kids Medication; Behavioral: Safe Storage Intervention

Detailed Description

This is a randomized controlled trial, that will utilize computer generated randomization, 1:1 intervention to control group ratio, randomized at the individual patient level. Randomization will occur after informed consent is obtained, before initial survey is administered. The Research Assistant will use computer generated randomization.

There will be 150 subjects per study arm (300 total). The two enrollment sites will each enroll 150 subjects (75 control and 75 intervention) with at least 33% being gun owners. For every 30 subjects enrolled, the site Principal Investigator and Research Assistant will ensure that 10 are gun owners. Once 20 non-owners are enrolled, non-gun owner enrollment will be paused until 10 gun owners are enrolled. This will ensure distribution of gun-owner enrollment over the entire study recruitment period. Enrollment will be ongoing until sample size is reached. Control group will receive an education intervention (video and handout) about the importance of securely storing medications in the home to prevent unintentional ingestions and suicide attempts. This is a multisite trial conducted at Monroe Carell Jr. Children's Hospital and Children's Hospital of Colorado.

During the initial study visit, after screening, enrollment including informed consent, randomization and baseline survey, the participant will either receive the Be SMART intervention (video shown on tablet) with Be SMART postcard sized handout OR the control intervention (SAFE KIDS medication storage video shown on tablet). Immediate post-intervention survey will be completed electronically, and the study visit will conclude.

The study intervention is the viewing of a brief educational video about the importance of secure firearm storage from the Be SMART program. Additionally, a secure storage device (cable gun lock) will be offered to families in the intervention group. A clinician will be available to answer any follow-up questions that study participants may have regarding secure firearm storage.

The control participants will view a brief medication storage safety video produced by SAFE KIDS. A clinician will be available to answer any follow-up questions that study participants may have regarding secure firearm storage. This control video was selected because like secure firearm storage it addresses youth injury risk mitigation and self-harm behavior prevention in the home.

There are two follow-up visits (electronic/phone, no in-person follow-up required): 1-month post-enrollment/intervention delivery and 3 months post-enrollment/intervention delivery. Participants will be contacted via their provided e-mail with a link to the follow-up survey. There will be 3 attempts to contact participants by email. If no response, participants will be contacted by phone, with 3 attempts. If the participants are unable to be reached at this point, they will be considered lost to follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justine Stassun, MS; Email: justine.c.stassun@vumc.org
• Study Contact Backup: Name: Kelsey Gastineau, MD, MPH; Phone Number: 615-936-7276; Email: kelsey.gastineau@vumc.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Kilinsky; Phone Number: 720-777-8335; Email: alexandra.kilinsky@childrenscolorado.org
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Monroe Carell Jr Children's Hospital at Vanderbilt
      • Contact: Gastineau; Phone Number: 615-875-9763; Email: kelsey.gastineau@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Guardians of hospitalized children in the active comparator group will view a brief medication storage safety video produced by Safe Kids.	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.
Experimental: 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.	Behavioral: Safe Storage Intervention; Firearm storage information and secure storage device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secure firearm storage among gun owners	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.	1 month
Asking about firearm storage among all participants	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).	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asking about firearm storage among all participants	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 of asking frequency (Never-Rarely - Sometimes - Always - Often).	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Firearm Storage Knowledge	Caregivers' knowledge and beliefs about firearm storage in the home will be assessed by asking survey questions "It is important for doctors who take care of children to talk to parents/ guardians about safe gun storage.", "It is important for people who have guns to store their firearms with a storage device such as a gun safe or trigger lock" and It is important for parents/guardians to ask if there are any guns in the home, when their child/children go to play in another person's home." with a 5-point Likert scale from Strongly Disagree to Strongly Agree.	1 month and 3 months
Secure firearm storage among gun owners	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.	3 months
Locking behavior	Self- report at two time points based on the survey question, "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 guardians who answered "Locked and Unloaded" or "Locked and Loaded" at follow up to the other two choices for a dichotomous measure.	1 month and 3 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Kelsey Gastineau, MD, MPH, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 241305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No