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Therapeutic Schools: Affect Management and HIV Prevention
This study is currently recruiting participants.
Verified by Rhode Island Hospital, January 2008
Sponsors and Collaborators: Rhode Island Hospital
University of Chicago
Information provided by: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00500487
  Purpose

Adolescents are at risk for HIV because of sexual and drug behavior intiated during this developmental period. Those with psychological distress are less likely than their peers to benefit from frequently used skills-based interventions. It appears that emotional lability during sexual situations disrupts skills learned. This project will implement and evaluate interventions for adolescents with psychiatric disorders who are in therapeutic school settings. Affect management and skills-based interventions will be compared to a didactic standard of care condition to determine which intervention best reduces risk behavior among adolescents with psychiatric disorders in therapeutic school settings.


Condition Intervention Phase
HIV Infections
Behavioral: Affect Management
Behavioral: HIV Prevention Skills
Behavioral: General Health Promotion
Phase I

MedlinePlus related topics: AIDS
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Therapeutic Schools: Affect Management and HIV Prevention

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Adolescent-reported condom use [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: April 2003
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Behavioral: Affect Management
12-session group intervention including affect management training as well as sexual health skills training.
2: Active Comparator Behavioral: HIV Prevention Skills
12-session group intervention including sexual health skills training.
3: Active Comparator Behavioral: General Health Promotion
12-session group intervention including health information on a variety of health topics.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adolescent attending therapeutic school

Exclusion Criteria:

  • Adolescent is HIV positive
  • Adolescent is developmentally delayed
  • Adolescent is pregnant
  • Adolescent has a history of sexual crime
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500487

Contacts
Contact: Larry K Brown, MD 401-444-8539 lkbrown@lifespan.org
Contact: Christopher D Houck, PhD 401-444-8539 chouck@lifespan.org

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

Responsible Party: Rhode Island Hospital ( Larry K. Brown/Principal Investigator )
Study ID Numbers: R01 MH066641, R01 MH066641
Study First Received: July 11, 2007
Last Updated: January 16, 2008
ClinicalTrials.gov Identifier: NCT00500487  
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
HIV prevention
HIV seronegativity

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009