Community-Based Violence Prevention for High-Risk Youth

Aggression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444197
• Other study ID #: R40MC00174-01
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2007
• Last updated: March 5, 2007
• Start date: August 2001
• Est. completion date: January 2006

Study information

• Verified date: March 2007
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardDHHS Sponsor: Maternal and Child Health Bureau
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aggression
• Fighting Behavior

Intervention

Behavioral:
• Mentoring and violence prevention curriculum with parental monitoring

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fighting behavior
Primary	Weapon carrying
Primary	Aggression
Primary	Misdemeanors
Secondary	Attitudes About Violence
Secondary	Self Efficacy