- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00748800
An Affect Management Intervention for Juvenile Offenders
February 5, 2009 updated by: Rhode Island Hospital
Adolescents are at risk for HIV because of sexual and drug behavior initiated during this developmental period.
Adolescents in the juvenile justice system are at increased risk for HIV due to higher rates of substance use and psychopathology than their non-offending peers.
Juvenile justice youth may therefore also be less likely to benefit from frequently used skills based interventions.
It appears that emotional lability, frequently found in this population, disrupts skills learned.
This project will implement and evaluate an affect management HIV prevention intervention for adolescents in a juvenile drug court program.
Affect management and general health promotion interventions will be compared to determine which intervention best reduces risk behavior among adolescents in the drug court.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adolescents enrolled in the juvenile drug court program
Exclusion Criteria:
- Adolescent is HIV positive
- Adolescent is pregnant
- Adolescent is developmentally delayed
- Adolescent has history of sexual crime
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
5 session group intervention that focused on teaching affect management skills and included HIV prevention and sexual health training
|
Active Comparator: 2
|
5 session group focused on delivering general health promotion information in didactic format
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adolescent-reported sexual activity and condom use
Time Frame: 3 month post-intervention
|
3 month post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adolescent substance use (self-report and urine toxicology screen results)
Time Frame: 3 months post-intervention
|
3 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Larry K Brown, MD, Rhode Island Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
September 5, 2008
First Submitted That Met QC Criteria
September 8, 2008
First Posted (Estimate)
September 9, 2008
Study Record Updates
Last Update Posted (Estimate)
February 6, 2009
Last Update Submitted That Met QC Criteria
February 5, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21DA019245 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Affect Management
-
Rhode Island HospitalCompletedHIV InfectionsUnited States
-
Rhode Island HospitalCompleted
-
Rhode Island HospitalUniversity of ChicagoCompleted
-
Max Planck Institute for Human Cognitive and Brain...European Research CouncilCompleted
-
Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedHypertensionUnited States
-
University of Colorado, BoulderNational Institute of Mental Health (NIMH)CompletedPhysical Activity | Affect
-
University of California, Los AngelesSouthern Methodist UniversityRecruiting
-
University of California, Los AngelesSouthern Methodist UniversityCompleted
-
Karolinska InstitutetTerminatedEmotional DysregulationSweden
-
Friedrich-Alexander-Universität Erlangen-NürnbergGerman Research Foundation; University Hospital Tuebingen; University of FreiburgCompleted