- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05078164
Preventing Firearm Violence in Youth: A Hospital-based Prevention Strategy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicholas Thomson
- Phone Number: 804-628-5541
- Email: Nicholas.Thomson@vcuhealth.org
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Youth are aged 10-17 years and their adult caregivers are aged 18 years and older
- Receiving treatment in the hospital for a violence-related injury (e.g., gunshot wound) or referred to BTG/IVPP services
- English speaking
- Eligible for BTG services (which includes living within the BTG catchment area for the hospital; Richmond City and neighboring counties)
Exclusion Criteria:
- Youth are < 10 years old
- Youth are > 18 years old
- Prisoners
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Treatment as Usual
Youth who will not receive BTG services and will receive treatment as usual (TAU) in the hospital.
|
|
|
Experimental: Bridging the Gap (BTG)
Youth randomized to Bridging the Gap (BTG) services will receive a hospital-based violence prevention program with 3-months of community case management and a firearm counseling program.
|
Bridging the Gap: Bridging the Gap is a hybrid model for violence prevention which integrates a hospital-based brief violence intervention (BVI) delivered to the patient while in hospital with a wrap-around community case management prevention strategy. Firearm Counseling Program: The firearm counseling program was developed to be administered in the hospital alongside the 6-step intervention program, as well as in the patient's home after hospital discharge. The firearm safety counseling program includes 3 components aimed at understanding patient risk, reducing firearm-related violence risk-factors, and helping patients increase firearm safety practices. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Firearm-related violence
Time Frame: 6 months
|
Total number of unique firearm-related violence incidents will be assessed multiple ways including self-report assessment and semi-structured clinical assessments.
|
6 months
|
|
Firearm-related carrying behaviors
Time Frame: 6 months
|
Total number of firearm-related carrying behaviors will be assessed multiple ways including self-report assessment and semi-structured clinical assessments.
|
6 months
|
|
Firearm-related beliefs
Time Frame: 6 months
|
Total number of firearm-related beliefs endorsed will be assessed multiple ways including self-report assessment and semi-structured clinical assessments.
|
6 months
|
|
Firearm-related re-injury
Time Frame: 6 months
|
Total number of unique firearm-related re-injury incidents will be measured multiple ways including self-report, caregiver-report, hospital records, and the National Death Index.
|
6 months
|
|
Firearm-related mortality
Time Frame: 6 months
|
Number of deaths will be collected from hospital records and the National Death Index.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicholas Thomson, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HM20022975
- 1R01HD108025 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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