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Sponsors and Collaborators: |
Rhode Island Hospital University of Chicago |
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Information provided by: | Rhode Island Hospital |
ClinicalTrials.gov Identifier: | NCT00500487 |
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 |
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HIV Infections |
Behavioral: Affect Management Behavioral: HIV Prevention Skills Behavioral: General Health Promotion |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Therapeutic Schools: Affect Management and HIV Prevention |
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 |
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1: Experimental |
Behavioral: Affect Management
12-session group intervention including affect management training as well as sexual health skills training.
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2: Active Comparator |
Behavioral: HIV Prevention Skills
12-session group intervention including sexual health skills training.
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3: Active Comparator |
Behavioral: General Health Promotion
12-session group intervention including health information on a variety of health topics.
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Ages Eligible for Study: | 13 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Larry K Brown, MD | 401-444-8539 | lkbrown@lifespan.org |
Contact: Christopher D Houck, PhD | 401-444-8539 | chouck@lifespan.org |
United States, Rhode Island | |
Rhode Island Hospital | Recruiting |
Providence, Rhode Island, United States, 02903 |
Principal Investigator: | Larry K Brown, MD | Rhode Island Hospital |
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 |
HIV prevention HIV seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |