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Community-Based Violence Prevention for High-Risk Youth
This study has been completed.
Sponsored by: Johns Hopkins University
Information provided by: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00444197
  Purpose

Study Aims: 1) Assess the receptiveness of youth and families to injury prevention interventions initiated from the emergency department; 2) In a sample of high risk youth presenting to the ED with interpersonal assault injuries, determine the effectiveness of a home-based family intervention with community linkage compared to a control group.


Condition Intervention Phase
Fighting Behavior
Aggression
Behavioral: Mentoring and violence prevention curriculum with parental monitoring
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Fighting behavior
  • Weapon carrying
  • Aggression
  • Misdemeanors

Secondary Outcome Measures:
  • Attitudes About Violence
  • Self Efficacy

Estimated Enrollment: 198
Study Start Date: August 2001
Estimated Study Completion Date: January 2006
Detailed Description:

The leading causes of death among U.S. children and adolescents are due to injuries. In the US, homicide is the third leading cause of death for 10-14 year olds and second leading cause of death for those 15-19 years. For African-Americans, homicide is the leading cause of death for males and females ages 15-34. Findings from our city-wide surveillance of adolescent injuries have found that for every death due to injury in youth, there were 8 hospitalizations and 102 ED visits. Non-fatal injuries represent significant morbidity and may be a sentinel event and opportunity for prevention.

Assault-injured patients age 9-15 and their families seen in the ED or hospitalized will be recruited into the study. Whenever possible, families will be recruited while they are still in the hospital, others will be contacted by phone. We will randomize families to an intervention group consisting of home visits involving a four session parental monitoring curriculum for parents and a 6-8 session mentoring and problem solving curriculum for youth occurring over 2-6 months. Both intervention and control groups will receive community referrals to needed services. Interview assessments of parents and youth will occur in person at baseline and 6 months, and by phone at 12 and 18 months after recruitment. Assessments will include face to face and Walkman questioning, and phone questioning with DigitGrabber touch tone response. The parent and youth assessments will include detail on cause of injury, past experience risk factors, protective factors, perceived risk and self-efficacy. Medical chart abstraction will be performed and aggregate data will be obtained from the police department about the number of youth in the intervention and control groups that have had contact with the police. We intend to recruit up to 400 families over 2-3 years in order to achieve follow-up with at least 198 families. Human Subjects: Male and female adolescents 9-15 years of age and their parents who are residents of the Washington Metropolitan area will be eligible for participation. Written parental consent and youth assent will be obtained. There are no physical risks. Potential risks include unintentional uses of the information gathered including disclosure of information that may be potentially legally incriminating. All efforts will be made to protect participant confidentiality. If information is revealed that places someone in immediate danger, disclosure may be necessary which is explained in the consent form. There are potential benefits including facilitated referral for therapeutic community-based intervention, access to an intervention of demonstrated effectiveness without cost, and cash incentives. In addition, they will contribute to knowledge about youth injury in the community.

  Eligibility

Ages Eligible for Study:   9 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adolescents age 9-15 presenting to a large urban children’s hospital or university hospital
  • residence in the metropolitan area
  • emergency department presentation with an interpersonal assault injuries (E960, 961-966, 968-969) excluding sexual assault, child abuse, sibling fights, or legal intervention
  • mental and physical ability of parent and child to participate in the intervention and assessments.

Exclusion Criteria:

  • sexual assault, child abuse, sibling fights, or legal intervention
  • non English speaking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444197

Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Tina L Cheng, MD, MPH Johns Hopkins University
  More Information

Publications indexed to this study:
Study ID Numbers: R40MC00174-01
Study First Received: March 5, 2007
Last Updated: March 5, 2007
ClinicalTrials.gov Identifier: NCT00444197  
Health Authority: United States: Institutional Review Board;   DHHS Sponsor: Maternal and Child Health Bureau

Study placed in the following topic categories:
Aggression
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009