Community-Based Violence Prevention for High-Risk Youth
Primary Purpose
Fighting Behavior, Aggression
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mentoring and violence prevention curriculum with parental monitoring
Sponsored by
About this trial
This is an interventional prevention trial for Fighting Behavior
Eligibility 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
Sites / Locations
- Children's National Medical Center
- Johns Hopkins University
Outcomes
Primary Outcome Measures
Fighting behavior
Weapon carrying
Aggression
Misdemeanors
Secondary Outcome Measures
Attitudes About Violence
Self Efficacy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00444197
Brief Title
Community-Based Violence Prevention for High-Risk Youth
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fighting Behavior, Aggression
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
198 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Mentoring and violence prevention curriculum with parental monitoring
Primary Outcome Measure Information:
Title
Fighting behavior
Title
Weapon carrying
Title
Aggression
Title
Misdemeanors
Secondary Outcome Measure Information:
Title
Attitudes About Violence
Title
Self Efficacy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina L Cheng, MD, MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18977971
Citation
Cheng TL, Haynie D, Brenner R, Wright JL, Chung SE, Simons-Morton B. Effectiveness of a mentor-implemented, violence prevention intervention for assault-injured youths presenting to the emergency department: results of a randomized trial. Pediatrics. 2008 Nov;122(5):938-46. doi: 10.1542/peds.2007-2096.
Results Reference
derived
Learn more about this trial
Community-Based Violence Prevention for High-Risk Youth
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