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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01770873
Recruitment Status : Active, not recruiting
First Posted : January 18, 2013
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Violence Behavioral: Take Charge 2 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Take Charge 2- A Multi-Center Randomized Trial of Mentoring to Prevent Youth Violence: Incorporating New Communication and Information Technology
Study Start Date : October 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

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

Primary Outcome Measures :
  1. Fighting [ Time Frame: Past 30 days ]
    Have you been in a physical fight in the past 30 days?

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01770873

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

Responsible Party: Johns Hopkins University Identifier: NCT01770873     History of Changes
Other Study ID Numbers: TC2-2P20
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Johns Hopkins University:
Emergency Room