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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04192318
Other study ID # HM20017786
Secondary ID 1K01CE003160-01
Status Terminated
Phase N/A
First received
Last updated
Start date February 10, 2020
Est. completion date February 10, 2020

Study information

Verified date March 2022
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to test if a hospital-based violence prevention strategy with a community-level initiative is effective for cross-cutting violence prevention in violently injured youth.


Description:

This study will test if youth who receive the Bridging the Gap (BTG) and Communities that Care (CTC Plus) will see greater improvements than youth who either receive BTG only, CTC Plus only or no intervention. This study will allow researchers to learn more about the intervention's effectiveness for a range of violent outcomes. It will also help researchers understand if violence prevention efforts affect other behaviors, such as drug use and rates of violent re-injury. Participants will be asked to complete surveys about their behavior, personality, and experiences, and their parent/child's personality, behavior, and experiences. These surveys take about 45-60 minutes to complete. These questionnaires will be completed before the intervention has taken place and then again 6 months later. Participation in this study will last up to 6 months. Approximately 408 individuals will participate in this study.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date February 10, 2020
Est. primary completion date February 10, 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years to 21 Years
Eligibility Inclusion Criteria: 1. Violently injured youth receiving treatment at VCU 2. Aged between 12 and 21 years old 3. Living in Richmond City 1. Parent/caregiver of the youth participant 2. Parent/caregivers must be 18 years old or older Exclusion Criteria: 1. Non-English speaking 2. Ages <12 and >21 years 3. Prisoners are excluded

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
Other:
Communities that Care (CTC)
In CTC programs stakeholders elect evidence-based prevention strategies that are most appropriate for their community. These evidence-based strategies target their community's specific needs, such as reducing risk factors while supporting and increasing protective factors.
Treatment as usual
Treat and release

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (2)

Lead Sponsor Collaborator
Virginia Commonwealth University Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in youth violence - self report Self-report aggression Baseline to 6 months
Primary Change in youth violence - caregiver report Caregiver-report of youth aggression Baseline to 6 months
Primary Change in youth dating violence Self-report physical and psychological dating aggression Baseline to 6 months
Primary Change in youth sexual violence Self-report sexual aggression Baseline to 6 months
Secondary Re-injury rate Hospital records of number of youth participants who experienced another injury due to violence between the intervention and 6-month follow-up 6 months
Secondary Community resources Self-report: Number of community resources youth are engaging in 6 months
Secondary Lost to follow-up rates Study report: The number of youth who we are unable to complete the follow-up assessment for because they are unreachable or decline to continue participation. 6 months
Secondary Change in trauma symptoms Self-report trauma symptoms Baseline to 6 months
Secondary Change in substance use Self-report of substance use Baseline to 6 months
Secondary Change in alcohol use Self-report of alcohol use Baseline to 6 months
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