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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01770873
Other study ID # NA_00075613
Secondary ID TC2-2P202P20MD00
Status Completed
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date September 2018

Study information

Verified date October 2018
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 15 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fighting Have you been in a physical fight in the past 30 days? Past 30 days
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