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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Tina L. Cheng, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01770873
First received: January 16, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Intervention
Violence Prevention
Behavioral: Take Charge 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Fighting [ Time Frame: Past 30 days ] [ Designated as safety issue: No ]
    Have you been in a physical fight in the past 30 days?


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770873

Locations
United States, District of Columbia
Children's National Medical Center Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact: Leticia Ryan, MD    202-476-5000    lryan@childrensnational.org   
Principal Investigator: Leticia Ryan, MD         
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Sarah R Lindstrom Johnson, PhD    410-614-3864    slj@jhmi.edu   
Principal Investigator: Tina L Cheng, MD, MPH         
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Tina L. Cheng, Professor, Division Chief General Academic Pediatrics, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01770873     History of Changes
Other Study ID Numbers: TC2-2P20
Study First Received: January 16, 2013
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Youth
Violence
Assault-injured
Mentoring
Emergency Room
Urban

ClinicalTrials.gov processed this record on July 28, 2014