HIV, Abuse, and Psychiatric Disorders Among Youth (Project STAR)

This study has been completed.
Information provided by:
Rhode Island Hospital Identifier:
First received: January 16, 2008
Last updated: February 5, 2009
Last verified: February 2009
One subgroup of adolescents at particular risk for HIV is those with psychiatric disorders. Furthermore, those with histories of sexual abuse have been found to have riskier attitudes, poorer sexual communication skills, and less consistent condom use than non-abused peers. This study implemented and evaluated interventions for adolescents in intensive psychiatric treatment settings, particularly those with histories of sexual abuse. It is hypothesized that those participating in the intervention that addresses affect management and cognitive monitoring strategies will show fewer HIV-risk related behaviors and attitudes at posttest than peers in an information-based intervention.

Condition Intervention Phase
HIV Infections
Behavioral: group intervention
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: HIV, Abuse, and Psychiatric Disorders Among Youth

Resource links provided by NLM:

Further study details as provided by Rhode Island Hospital:

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

Secondary Outcome Measures:
  • scores on HIV knowledge questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • number of sexual partners [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • scores on measure of attitudes toward condom use [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 212
Study Start Date: September 1999
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
13 session group intervention including sexual health information, affect management skills, cognitive monitoring, and communication skills training.
Behavioral: group intervention
13-session intervention
Active Comparator: 2
2 session group intervention including sexual health information training.
Behavioral: group intervention
2-session intervention


Ages Eligible for Study:   13 Years to 19 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
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 identifier: NCT00603369

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Larry K. Brown/Principal Investigator, Rhode Island Hospital Identifier: NCT00603369     History of Changes
Other Study ID Numbers: R01MH061149 
Study First Received: January 16, 2008
Last Updated: February 5, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
HIV prevention
HIV seronegativity

Additional relevant MeSH terms:
Mental Disorders
Problem Behavior
Behavioral Symptoms processed this record on May 24, 2016