BeSMART Secure Storage Counseling in the Inpatient Setting

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Safe Storage Intervention

    Behavioral

    Firearm storage information and secure storage device.

  • Safe Kids Medication

    Behavioral

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month
2

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).

Time frame
1 month

Secondary outcomes

1

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).

Time frame
3 months

Other outcomes

1

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.

Time frame
1 month and 3 months
2

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.

Time frame
3 months
3

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.

Time frame
1 month and 3 months

Sponsors and contacts

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