Therapeutic Schools: Affect Management and HIV Prevention

This study has been completed.
University of Chicago
Information provided by (Responsible Party):
Rhode Island Hospital Identifier:
First received: July 11, 2007
Last updated: January 9, 2015
Last verified: October 2009
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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Therapeutic Schools: Affect Management and HIV Prevention

Resource links provided by NLM:

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


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

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
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Please refer to this study by its identifier: NCT00500487

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

Responsible Party: Rhode Island Hospital Identifier: NCT00500487     History of Changes
Other Study ID Numbers: R01MH066641 
Study First Received: July 11, 2007
Last Updated: January 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
HIV prevention
HIV seronegativity processed this record on May 24, 2016