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

StatusWithdrawn
PhaseNot applicable
Started

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Record History

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  1. Reclassified as withdrawn (was completed) Sponsor's reason: Study terminated prior to enrollment due to insufficient funding and staffing resources to conduct the project as designed. No participants were enrolled. Show 4 more changesShow less
    • Enrollment target: 2 to 0
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised
  2. Enrollment target: estimated 180 to confirmed 2v7 Show 4 more changesShow less
    • Trial status: Recruiting to Completed
    • Primary completion date changed from estimate of Mar 2026 to Dec 1, 2025
    • Study completion date changed from estimate of Apr 2026 to Jan 10, 2026
    • Site details revised
  3. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Feb 2026 to Mar 2026
    • Study completion date: Feb 2026 to Apr 2026
    • Start date changed from estimate of May 1, 2025 to Jul 8, 2025
  4. Start date: Mar 1, 2025 to May 1, 2025
    • Primary completion date: Dec 2025 to Feb 2026
    v5
  5. Start date: Jan 15, 2025 to Mar 1, 2025v4
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  1. Start date: Oct 2024 to Jan 15, 2025
    • Primary completion date: Sep 2025 to Dec 2025
    • Study completion date: Dec 2025 to Feb 2026
    v3
  2. Start date: Aug 2024 to Oct 2024v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06479889
Lead Sponsor Vanderbilt University Medical Center
Conditions
(from sponsor)		 Firearm Injury, Hospitalizations Psychiatric
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov