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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Fighting Behavior, Aggression
- 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.
Fighting behavior
Weapon carrying
Aggression
Misdemeanors
Secondary outcomes (2)
Attitudes About Violence
Self Efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startAug 2001
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fighting BehaviorStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Investigators
- Tina L Cheng, MD, MPH, Principal investigator, Johns Hopkins University
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Violence Prevention for High-Risk Youth
- ClinicalTrials.gov ID
- NCT00444197
- Acronym / sponsor ID
- R40MC00174-01
- Conditions
- Fighting Behavior, Aggression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Aug 2001
- Study completion
- Jan 2006
- First posted
- 7 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- sexual assault, child abuse, sibling fights, or legal intervention
- non English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentoring and violence prevention curriculum with parental monitoring | Behavioural | – |
Primary outcome
Fighting behavior
Weapon carrying
Aggression
Misdemeanors
2 secondary outcomes
Attitudes About Violence
Self Efficacy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2007.
- Derived from this study: PubMed 18977971Cheng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina L Cheng, MD, MPH principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
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.