A Multi-Center Randomized Controlled Trial of Mentoring to Prevent Youth Violence (TC2)

October 4, 2018 updated by: Johns Hopkins University

Take Charge 2- A Multi-Center Randomized Trial of Mentoring to Prevent Youth Violence: Incorporating New Communication and Information Technology

The purpose of this study is to test whether a violence prevention curriculum delivered by Big Brothers and Big Sisters staff and mentors can reduce violence involvement for assault-injured youth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Violent injury is a major cause of morbidity and mortality among adolescents. The presence of a positive adult role model is a well-established protective factor against violence and other maladaptive outcomes among youth. Big Brothers Big Sisters (BBBS) is the largest U.S. mentoring organization with proven effectiveness in improving youth outcomes. However, these programs may be less effective with youth who already are exhibiting involvement in problem behavior at the time of program referral. Take Charge!, a mentor- and professional-implemented intervention with 10-15 year old assault-injured youth, showed promise for improving perceived self efficacy for avoiding violence and for decreasing aggression and problem behavior.

The overall goal of the proposed project is to develop, implement, and evaluate a research-informed youth development program that adapts the BBBS model to work for assault-injured youth. The aims are:

  • To expand and refine Take Charge! and integrate it with BBBS practices;
  • To conduct a randomized, controlled trial in which assault-injured 10-15 year old youth recruited from emergency departments in Baltimore and D.C. receive either standard emergency department follow-up care or the Take Charge! 2 intervention with assessment of violence-related, mental health, and educational outcomes;
  • To conduct a comprehensive process evaluation of Take Charge! 2;
  • And to accurately measure the costs of the intervention and assess cost-effectiveness.

Youth violence is a major cause of morbidity and mortality with marked disparities by race/ethnicity and socioeconomic status. This study is a critical next step in translating evidence-based research to real-world settings and practice.

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Treatment for an assault injury in the emergency room
  • English speaking (parent and youth)

Exclusion Criteria:

  • Treatment for child abuse, sexual abuse, sibling fights, or police fights
  • Severe psychopathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Take Charge 2
Receipt of BBBS mentoring plus youth and parent violence prevention curriculum
Behavioral: Take Charge 2
Youth assigned to the intervention receive a Big Brothers, Big Sisters (BBBS) mentor. During the match process, BBBS staff provide 3 session on violence prevention for the youth's parents. Six months into the mentoring relationship, mentors provide 6 sessions on violence prevention for the youth.
No Intervention: Control
Standard emergency room protocol followed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fighting
Time Frame: Past 30 days
Have you been in a physical fight in the past 30 days?
Past 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Tina L Cheng, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NA_00075613
  • TC2-2P20 (Other Identifier: Other)
  • 2P20MD000198-11 (U.S. NIH Grant/Contract)

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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