Firearm InjuryNCT06479889
Safer Storage Safer Homes An Inpatient Pediatric Lethal Means Counseling Pilot Trial
A study testing Guardians receiving counseling + lock in people with Firearm Injury and Hospitalizations Psychiatric, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Firearm injuries are the leading cause of death for American youth. Strikingly, firearm suicide among adolescents is growing faster than other groups. Lethal means counseling is standard of care, however, infrequently occurs despite pediatricians recognizing the importance. 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, Hospitalizations Psychiatric
- What is being tested?
- Guardians receiving counseling + lock
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2025to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Guardian of child ages 0-18 years old who is admitted to and receiving care on the MCJCHV Behavioral Health Team
- Guardian age > or = 18 years
- Guardian with phone access to receive calls or email access to receive study information electronically
- English or Spanish-speaking guardian
- Guardian self-identifies as firearm owner
Who cannot join
- Guardian of children outside the specified age range
- Guardian speaks a language that is not English or Spanish
- Lack of telephone or email contact
- Guardian age is outside of the specific age range
- Guardians/children who do not otherwise meet the eligibility criteria listed in section above as determined by pre-screen
- Guardian or child in distress at time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
About this study
Official title: Safer Storage Safer Homes: Investigating the Use of Secure Storage Devices in the Inpatient Behavioral Health Population
Firearm injuries are the leading cause of death for American youth. Strikingly, firearm suicide among adolescents is growing faster than other groups. Lethal means counseling is standard of care, however, infrequently occurs despite pediatricians recognizing the importance. Lack of time, topic discomfort, and inadequate resources for families are commonly reported barriers to counseling. By addressing these factors, we can improve counseling with the ultimate goal of increasing safe storage and reducing firearm injuries in youth.
Children admitted in acute mental health crises while awaiting psychiatric hospital placement are a population at greater risk of suicide. We plan to implement a pilot intervention to offer secure storage counseling and storage device distribution to families of behavioral health patients who indicate firearm ownership on initial screening. The goal of this project is to evaluate the feasibility and acceptability of firearm secure storage counseling and device provision in the inpatient setting.
Read the detailed description
The Behavioral Health service at Monroe Carell Jr Children's Hospital at Vanderbilt (MCJCHV) provides specialized care for children and adolescents offering settings for patients to feel safe and supported while awaiting inpatient psychiatric care. Patients admitted to this team include children and adolescents with behavioral and psychological health challenges, including anxiety, depression, emotional distress, mood or personality disorders and many other mental health issues placing them at increased risk from harm from lethal means (sharps, medications, and firearms). Reducing immediate access to lethal means may mitigate the risk of fatal self-harm in youth. While likely beneficial in the inpatient setting, only one study exists examining the effects of an educational intervention for parents of hospitalized children.
To address this gap, we plan to implement a pilot intervention to offer secure storage counseling and device distribution to families of behavioral health patients who indicate firearm ownership on initial screening. The primary goal of this project is to determine the utilization and feasibility of providing these tools in the inpatient setting. We will additionally be assessing the feasibility of recruiting and retaining participants as well as the acceptability offering secure storage counseling in our study population to help inform future studies.
This will be a single arm observational pilot study. Participants will be asked to complete a pre- and post-survey via REDCap. Participants will first complete a self-guided pre-survey including demographic questions and current behaviors for medication and firearm storage. There will then be a 5-minute injury prevention educational session (lethal means counseling which is an underperformed standard of care for patients admitted with behavioral or mental health needs) informed by current evidence. The participants will also complete an online self-guided follow-up survey 1 month following the educational training. A REDCap link will be sent to the participant via email. Reminders will be sent at 1,2, and 7 days. Participants will be compensated for their participation.
- Conditions
- Firearm Injury, Hospitalizations Psychiatric
- Being tested
- Guardians receiving counseling + lock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardians receiving counseling + lockBehavioural
Guardians of patients admitted to the Pediatric Hospital Medicine behavioral health team will be provided a brief lethal means educational session and offered up to 3 secure storage devices of their choosing (lock box and or cable locks)
| Study group | Role | What they receive |
|---|---|---|
| Counseling + Lock provision | Experimental | Guardians of patients admitted to the behavioral health team who identify as firearm owners will be provided lethal means counseling and offered up to 3 secure storage devices of their choosing. Receives: Behavioral: Guardians receiving counseling + lock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secure Storage Device Uptake
The proportion of eligible families who take at least 1 storage device (cable locks or lock boxes). The numerator is defined as the number of guardians who take a firearm secure storage device when offered and the denominator is defined as the number of families included in the study.
Measured: 1 day (Assessed at Initial survey)
Secondary outcomes (3)
Secure Storage Device Usage
The proportion of eligible families who self-report using the chosen device at time of 3-month follow up survey. This will be assessed via the survey question "Are you using any of the device(s) to lock a firearm?" with a dichotomous "Yes/No" response option.
Measured: one month
Feasibility of follow up
Feasibility of completing a follow up survey with parents within 1 month after the intervention measured by the proportion of guardian who complete the survey in its entirety either electronically or by phone.
Measured: one month
Acceptability of intervention
Acceptability will be measured using the Acceptability Intervention Measure, a 4-item instrument measuring the acceptability of an intervention on a 5-point Likert scale (Completely Disagree-Completely Agree).
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start8 Jul 2025
- Primary completion1 Dec 2025
- Study completion10 Jan 2026
Why it stopped: Study terminated prior to enrollment due to insufficient funding and staffing resources to conduct the project as designed. No participants were enrolled.
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479889
- Sponsor's protocol ID
- 242424
- Status last verified
- May 2026
- First submitted
- 24 Jun 2024
- Last updated
- 5 Oct 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safer Storage Safer Homes: Investigating the Use of Secure Storage Devices in the Inpatient Behavioral Health Population
- ClinicalTrials.gov ID
- NCT06479889
- Acronym / sponsor ID
- 242424
- Conditions
- Firearm Injury, Hospitalizations Psychiatric
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated prior to enrollment due to insufficient funding and staffing resources to conduct the project as designed. No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 28 Jun 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. Strikingly, firearm suicide among adolescents is growing faster than other groups. Lethal means counseling is standard of care, however, infrequently occurs despite pediatricians recognizing the importance. Lack of time, topic discomfort, and inadequate resources for families are commonly reported barriers to counseling. By addressing these factors, we can improve counseling with the ultimate goal of increasing safe storage and reducing firearm injuries in youth.
Children admitted in acute mental health crises while awaiting psychiatric hospital placement are a population at greater risk of suicide. We plan to implement a pilot intervention to offer secure storage counseling and storage device distribution to families of behavioral health patients who indicate firearm ownership on initial screening. The goal of this project is to evaluate the feasibility and acceptability of firearm secure storage counseling and device provision in the inpatient setting.
Detailed description
The Behavioral Health service at Monroe Carell Jr Children's Hospital at Vanderbilt (MCJCHV) provides specialized care for children and adolescents offering settings for patients to feel safe and supported while awaiting inpatient psychiatric care. Patients admitted to this team include children and adolescents with behavioral and psychological health challenges, including anxiety, depression, emotional distress, mood or personality disorders and many other mental health issues placing them at increased risk from harm from lethal means (sharps, medications, and firearms). Reducing immediate access to lethal means may mitigate the risk of fatal self-harm in youth. While likely beneficial in the inpatient setting, only one study exists examining the effects of an educational intervention for parents of hospitalized children.
To address this gap, we plan to implement a pilot intervention to offer secure storage counseling and device distribution to families of behavioral health patients who indicate firearm ownership on initial screening. The primary goal of this project is to determine the utilization and feasibility of providing these tools in the inpatient setting. We will additionally be assessing the feasibility of recruiting and retaining participants as well as the acceptability offering secure storage counseling in our study population to help inform future studies.
This will be a single arm observational pilot study. Participants will be asked to complete a pre- and post-survey via REDCap. Participants will first complete a self-guided pre-survey including demographic questions and current behaviors for medication and firearm storage. There will then be a 5-minute injury prevention educational session (lethal means counseling which is an underperformed standard of care for patients admitted with behavioral or mental health needs) informed by current evidence. The participants will also complete an online self-guided follow-up survey 1 month following the educational training. A REDCap link will be sent to the participant via email. Reminders will be sent at 1,2, and 7 days. Participants will be compensated for their participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Counseling + Lock provision | Experimental | Behavioral: Guardians receiving counseling + lockGuardians of patients admitted to the behavioral health team who identify as firearm owners will be provided lethal means counseling and offered up to 3 secure storage devices of their choosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Guardian of child ages 0-18 years old who is admitted to and receiving care on the MCJCHV Behavioral Health Team
- Guardian age > or = 18 years
- Guardian with phone access to receive calls or email access to receive study information electronically
- English or Spanish-speaking guardian
- Guardian self-identifies as firearm owner
Key exclusion criteria (6 listed)
- Guardian of children outside the specified age range
- Guardian speaks a language that is not English or Spanish
- Lack of telephone or email contact
- Guardian age is outside of the specific age range
- Guardians/children who do not otherwise meet the eligibility criteria listed in section above as determined by pre-screen
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 |
|---|---|---|
| Guardians receiving counseling + lockGuardians of patients admitted to the Pediatric Hospital Medicine behavioral health team will be provided a brief lethal means educational session and offered up to 3 secure storage devices of their choosing (lock box and or cable locks) | Behavioural | Counseling + Lock provision |
Primary outcome
Secure Storage Device Uptake
Time frame: 1 day (Assessed at Initial survey)
The proportion of eligible families who take at least 1 storage device (cable locks or lock boxes). The numerator is defined as the number of guardians who take a firearm secure storage device when offered and the denominator is defined as the number of families included in the study.
3 secondary outcomes
Secure Storage Device Usage
Time frame: one month
Feasibility of follow up
Time frame: one month
Acceptability of intervention
Time frame: one month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 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. This study is not recruiting at the moment.
Kelsey Gastineau principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guardians receiving counseling + lock in people with Firearm Injury and Hospitalizations Psychiatric, run by Vanderbilt University Medical Center at 1 site 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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secure Storage Device Uptake (time frame: 1 day (Assessed at Initial survey)). 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 5 Oct 2026.