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CompletedNCT00444197Updated Mar 7, 2007

Community-Based Violence Prevention for High-Risk Youth

A Phase 2 interventional study of Mentoring and violence prevention curriculum with parental monitoring in Fighting Behavior and Aggression, sponsored by Johns Hopkins University. Completed at 2 sites in United States. Open to participants aged 9 Years to 15 Years. Per ClinicalTrials.gov, last updated 2007-03-07.

Sponsored by Johns Hopkins University · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
198
Allocation
Randomized
Ages
9 Years to 15 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fighting Behavior
  • Aggression

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03

In context

Aggression

361 studies on the registry are indexed under Aggression; 51 are open to participants now.

This study's enrollment of 198 is above the median of 60 across 293 interventional studies indexed under Aggression.

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Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • sexual assault, child abuse, sibling fights, or legal intervention
  • non English speaking
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
198 participants

Interventions

  • BehavioralMentoring and violence prevention curriculum with parental monitoring
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What researchers measure

Primary outcomes

  1. Fighting behavior

  2. Weapon carrying

  3. Aggression

  4. Misdemeanors

Secondary outcomes

  1. Attitudes About Violence

  2. Self Efficacy

07

Study locations

2 sites
  • Children's National Medical Center
    Washington, District of Columbia 20010, United States
  • Johns Hopkins University
    Baltimore, Maryland 21287, United States
08

References and documents

Publications

  • 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. PubMed 18977971 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00444197
Lead sponsor
Johns Hopkins University
First posted
Mar 7, 2007
Start date
Aug 2001
Completion
Jan 2006
Last update
Mar 7, 2007

Study contacts

Tina L Cheng, MD, MPH
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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