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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05078164
Other study ID # HM20022975
Secondary ID 1R01HD108025
Status Recruiting
Phase N/A
First received
Last updated
Start date May 4, 2022
Est. completion date May 2024

Study information

Verified date May 2023
Source Virginia Commonwealth University
Contact Nicholas Thomson
Phone 804-628-5541
Email Nicholas.Thomson@vcuhealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of the study is to understand if hospital-based violence interventions are effective for reducing youth violence among violently injured youth. This study will allow researchers to learn more about the intervention's effectiveness. The researchers also want to understand if the violence intervention impacts other behaviors, such as firearm use, drug use, aggression, risky behaviors, and rates of violent re-injury.


Description:

The purpose of this research study is to find out if a hospital-based violence intervention (Bridging the Gap) is effective for reducing youth violence. Researchers think that youth who receive the Bridging the Gap will see greater improvements than youth who do not receive the intervention. Approximately 300 youth patients and 300 adult caregivers will enroll in this study. Participants will be randomized into a study group (either Bridging the Gap or Treatment as Usual). If patients agree to the study but do not like the group they are assigned to, they can request to switch groups. Participants assigned to the Treatment as Usual intervention will receive a brief violence awareness brochure during their hospital stay. Participants assigned to the Bridging the Gap intervention will receive an in-hospital intervention and, once released from the hospital, will receive 3-months of community case management services with their families. The study team thinks that youth who receive the Bridging the Gap intervention will see greater improvements than youth who do not receive the intervention. Participation in this study will last up to 6 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 10 Years to 17 Years
Eligibility Inclusion Criteria: 1. Youth are aged 10-17 years and their adult caregivers are aged 18 years and older 2. Receiving treatment in the hospital for a violence-related injury (e.g., gunshot wound) or referred to BTG/IVPP services 3. English speaking 4. Eligible for BTG services (which includes living within the BTG catchment area for the hospital; Richmond City and neighboring counties) Exclusion Criteria: 1. Youth are < 10 years old 2. Youth are > 18 years old 3. Prisoners

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Bridging the Gap (BTG)
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.

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (2)

Lead Sponsor Collaborator
Virginia Commonwealth University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Firearm-related violence Total number of unique firearm-related violence incidents will be assessed multiple ways including self-report assessment and semi-structured clinical assessments. 6 months
Primary Firearm-related carrying behaviors Total number of firearm-related carrying behaviors will be assessed multiple ways including self-report assessment and semi-structured clinical assessments. 6 months
Primary Firearm-related beliefs Total number of firearm-related beliefs endorsed will be assessed multiple ways including self-report assessment and semi-structured clinical assessments. 6 months
Primary Firearm-related re-injury 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
Primary Firearm-related mortality Number of deaths will be collected from hospital records and the National Death Index. 6 months
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