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Fighting BehaviorPhase 2NCT00444197

Community-Based Violence Prevention for High-Risk Youth

A Phase 2 study testing Mentoring and violence prevention curriculum with parental monitoring in people with Fighting Behavior and Aggression, run by Johns Hopkins University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 9 to 15 years
Conditions the study is for
Fighting Behavior, Aggression
What is being tested?
Mentoring and violence prevention curriculum with parental monitoring
How many people
198 participants
Where
2 sitesUnited States
Study dates
Aug 2001to Jan 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

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.

Being tested
Mentoring and violence prevention curriculum with parental monitoring
Medical subject headings
Aggression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mentoring and violence prevention curriculum with parental monitoringBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fighting behavior

  2. Weapon carrying

  3. Aggression

  4. Misdemeanors

Secondary outcomes (2)
  1. Attitudes About Violence

  2. Self Efficacy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2007 (estimated)
  2. Study startAug 2001
  3. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
198 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00444197
Sponsor's protocol ID
R40MC00174-01
Status last verified
Mar 2007
First submitted
5 Mar 2007
Last updated
7 Mar 2007
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mentoring and violence prevention curriculum with parental monitoring in people with Fighting Behavior and Aggression, run by Johns Hopkins University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fighting behavior. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00444197, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2007.

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