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

NCT04192318 | Terminated

• 2 other identifiers: HM200177861K01CE003160-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Violence in Adolescence

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Re-injury rate

  6 months

• Community resources

  6 months

• Lost to follow-up rates

  6 months

• Change in trauma symptoms

  Baseline to 6 months

• Change in substance use

  Baseline to 6 months

Study Arms (4)

Hospital-based violence prevention with community initiative

EXPERIMENTAL

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; Other: Communities that Care (CTC)

Hybrid hospital based violence prevention

EXPERIMENTAL

Youth who do not live in a community that has CTC but will receive BTG.

Behavioral: Bridging the Gap

Treatment as usual

ACTIVE COMPARATOR

Youth living in a community without the CTC program and will receive treatment as usual (TAU) in the hospital.

Other: Treatment as usual

Treatment as usual with community initiative

EXPERIMENTAL

Youth living in a community with the CTC program and will receive treatment as usual (TAU) in the hospital.

Other: Communities that Care (CTC); Other: Treatment as usual

Interventions

Bridging the Gap BEHAVIORAL

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.

Hospital-based violence prevention with community initiative; Hybrid hospital based violence prevention

Communities that Care (CTC) OTHER

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.

Hospital-based violence prevention with community initiative; Treatment as usual with community initiative

Treatment as usual OTHER

Treat and release

Treatment as usual; Treatment as usual with community initiative

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Violently injured youth receiving treatment at VCU
• Aged between 12 and 21 years old
• Living in Richmond City
• \. Parent/caregiver of the youth participant 2. Parent/caregivers must be 18 years old or older

You may not qualify if:

• Non-English speaking
• Ages \<12 and \>21 years
• Prisoners are excluded

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Nicholas Thomson, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: February 10, 2020
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be made available after the main study findings have been published and up to five years after study completion.
• 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.

Locations

US (1)