Viewing Study NCT06479889



Ignite Creation Date: 2024-07-17 @ 10:55 AM
Last Modification Date: 2024-10-26 @ 3:33 PM
Study NCT ID: NCT06479889
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-28
First Post: 2024-06-24

Brief Title: Safer Storage Safer Homes an Inpatient Pediatric Lethal Means Counseling Pilot Trial
Sponsor: Vanderbilt University Medical Center
Organization: Vanderbilt University Medical Center

Study Overview

Official Title: Safer Storage Safer Homes Investigating the Use of Secure Storage Devices in the Inpatient Behavioral Health Population
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Childrens 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 12 and 7 days Participants will be compensated for their participation

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None