Evaluating Outcomes for Youth Receiving Hospital-based Violence Prevention With and Without a Community-level Initiative

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.

Study Overview

• Status: Terminated
• Conditions: Violence in Adolescence
• Intervention / Treatment: Behavioral: Bridging the Gap; Other: Communities that Care (CTC); Other: Treatment as usual

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hospital-based violence prevention with community initiative; Youth who are living in communities that receive Communities that Care Prevention System (CTC) will also receive Bridging the Gap (BTG), a hospital-based violence prevention program with 6-months of community case management.	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.
Experimental: Hybrid hospital based violence prevention; Youth who do not live in a community that has CTC but will receive BTG.	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.
Active Comparator: Treatment as usual; Youth living in a community without the CTC program and will receive treatment as usual (TAU) in the hospital.	Other: Treatment as usual; Treat and release
Experimental: Treatment as usual with community initiative; Youth living in a community with the CTC program and will receive treatment as usual (TAU) in the hospital.	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.; Other: Treatment as usual; Treat and release

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in youth violence - self report	Self-report aggression	Baseline to 6 months
Change in youth violence - caregiver report	Caregiver-report of youth aggression	Baseline to 6 months
Change in youth dating violence	Self-report physical and psychological dating aggression	Baseline to 6 months
Change in youth sexual violence	Self-report sexual aggression	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Community resources	Self-report: Number of community resources youth are engaging in	6 months
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
Change in trauma symptoms	Self-report trauma symptoms	Baseline to 6 months
Change in substance use	Self-report of substance use	Baseline to 6 months
Change in alcohol use	Self-report of alcohol use	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Nicholas Thomson, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): February 10, 2020
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HM20017786; 1K01CE003160-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data will be available for sharing.
• IPD Sharing Time Frame: Data will be made available after the main study findings have been published and up to five years after study completion.
• IPD Sharing Access Criteria: Data are available for sharing with researchers requesting data from the Principal Investigator. Interested investigators will be required to complete a Data Use Agreement Form which outlines the specific data being requested and a summary of the research question(s). Distribution of data and associated documentation will be subject to review by the research team (PI and study team). The Data Use Agreement provides a commitment to: a) use the data only for research purposes, and not to identify any individual participant, b) secure the data using appropriate security measures and computer technology, and c) destroy and/or return the data after analyses are completed. The interested investigators shall provide the data analytic plan and study aims for the PI and study team's approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No