Firearm InjuryBeSMARTNCT06485141
BeSMART Secure Storage Counseling in the Inpatient Setting
A study testing Safe Storage Intervention and Safe Kids Medication in people with Firearm Injury and Safety Issues, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Firearm Injury, Safety Issues
- What is being tested?
- Safe Storage Intervention and Safe Kids Medication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Sep 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Justine Stassun, MS contact
United States2 sites, 2 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Kilinsky, 720-777-8335, alexandra.kilinsky@childrenscolorado.org
- Recruiting
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Gastineau, 615-875-9763, kelsey.gastineau@vumc.org
About this study
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.
Read the 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.
- Conditions
- Firearm Injury, Safety Issues
- Being tested
- Safe Storage Intervention, Safe Kids Medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe Storage InterventionBehavioural
Firearm storage information and secure storage device.
Safe Kids MedicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Guardians of hospitalized children in the active comparator group will view a brief medication storage safety video produced by Safe Kids. Receives: Behavioral: Safe Kids Medication |
| Intervention | Experimental | 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. Receives: Behavioral: Safe Storage Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start20 Sep 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Firearm InjuryStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelsey Gastineau, Vanderbilt University Medical Center
- Investigators
- Kelsey Gastineau, MD, MPH, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485141
- Sponsor's protocol ID
- 241305
- Acronym
- BeSMART
- Status last verified
- May 2026
- First submitted
- 10 Jun 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BeSMART Secure Storage Counseling in the Inpatient Setting
- ClinicalTrials.gov ID
- NCT06485141
- Acronym / sponsor ID
- BeSMART / 241305
- Conditions
- Firearm Injury, Safety Issues
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Safe Kids MedicationGuardians of hospitalized children in the active comparator group will view a brief medication storage safety video produced by Safe Kids. |
| Intervention | Experimental | Behavioral: Safe Storage InterventionGuardians 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe Storage InterventionFirearm storage information and secure storage device. | Behavioural | Intervention |
| Safe Kids MedicationThe 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. | Behavioural | Control |
Primary outcome
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).
1 secondary outcome
Asking about firearm storage among all participants
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justine Stassun, MS contact
Kelsey Gastineau, MD, MPH principal investigator
Vanderbilt University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe Storage Intervention and Safe Kids Medication in people with Firearm Injury and Safety Issues, run by Vanderbilt University Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsey Gastineau, MD, MPH (615-936-7276, kelsey.gastineau@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secure firearm storage among gun owners (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.