Therapeutic Schools: Affect Management and HIV Prevention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Rhode Island Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Chicago
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00500487
First received: July 11, 2007
Last updated: November 17, 2009
Last verified: October 2009
  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 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
Estimated 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500487

Locations
United States, Rhode Island
Rhode Island Hospital
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

No publications provided

Responsible Party: Larry K. Brown/Principal Investigator, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00500487     History of Changes
Other Study ID Numbers: R01 MH066641, R01 MH066641
Study First Received: July 11, 2007
Last Updated: November 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
HIV prevention
HIV seronegativity

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

ClinicalTrials.gov processed this record on July 29, 2014