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

NCT06479889 | Recruiting

• 1 other identifier: 242424
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Firearm Injury; Hospitalizations Psychiatric

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day (Assessed at Initial survey)

Secondary Outcomes (3)

• Secure Storage Device Usage

  one month

• Feasibility of follow up

  one month

• Acceptability of intervention

  one month

Other Outcomes (2)

• Feasibility of enrollment

  Throughout the study, approximately one year

• Secure firearm storage

  one month

Study Arms (1)

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.

Behavioral: Guardians receiving counseling + lock

Interventions

Guardians receiving counseling + lock 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)

Counseling + Lock provision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

RECRUITING

Study Officials

• Kelsey Gastineau

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

615-936-7276; kelsey.gastineau@vumc.org

Justine Stassun, MS

CONTACT

justine.c.stassun@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: July 8, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)