Safer Storage Safer Homes An Inpatient Pediatric Lethal Means Counseling Pilot Trial

NCT ID: NCT06479889

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2026-04-30

Brief 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. 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.

Conditions

Firearm Injury; Hospitalizations Psychiatric

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Counseling + Lock provision

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.

Group Type: EXPERIMENTAL

Guardians receiving counseling + lock

Intervention Type: BEHAVIORAL

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)

Interventions

Guardians receiving counseling + lock

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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Guardian of child ages 0-18 years old who is admitted to and receiving care on the MCJCHV Behavioral Health Team

2. Guardian age > or = 18 years

3. Guardian with phone access to receive calls or email access to receive study information electronically

4. English or Spanish-speaking guardian

5. Guardian self-identifies as firearm owner

Exclusion Criteria

1. Guardian of children outside the specified age range

2. Guardian speaks a language that is not English or Spanish

3. Lack of telephone or email contact

4. Guardian age is outside of the specific age range

5. Guardians/children who do not otherwise meet the eligibility criteria listed in section above as determined by pre-screen

6. Guardian or child in distress at time of enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kelsey Gastineau

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelsey Gastineau

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

justine.c.stassun@vumc.org Gastineau, MD MPH

Role: CONTACT

kelsey.gastineau@vumc.org

615-936-7276

Justine Stassun, MS

Role: CONTACT

justine.c.stassun@vumc.org

Facility Contacts

Kelsey Gastineau, MD MPH

Role: primary

kelsey.gastineau@vumc.org

615-875-9763

Other Identifiers

242424

Identifier Type: -

Identifier Source: org_study_id