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An Affect Management Intervention for Juvenile Offenders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00748800
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : February 6, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Affect Management Behavioral: General Health Promotion Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Affect Management Intervention for Juvenile Offenders
Study Start Date : September 2004
Primary Completion Date : May 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Behavioral: Affect Management
5 session group intervention that focused on teaching affect management skills and included HIV prevention and sexual health training
Active Comparator: 2 Behavioral: General Health Promotion
5 session group focused on delivering general health promotion information in didactic format


Outcome Measures

Primary Outcome Measures :
  1. Adolescent-reported sexual activity and condom use [ Time Frame: 3 month post-intervention ]

Secondary Outcome Measures :
  1. Adolescent substance use (self-report and urine toxicology screen results) [ Time Frame: 3 months post-intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748800


Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Larry K Brown, MD Rhode Island Hospital
More Information

Responsible Party: Larry K. Brown, M.D./Principal Investigator, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00748800     History of Changes
Other Study ID Numbers: R21DA019245 ( U.S. NIH Grant/Contract )
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009

Keywords provided by Rhode Island Hospital:
HIV prevention
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases