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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00603369
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : February 6, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Behavioral: group intervention Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: HIV, Abuse, and Psychiatric Disorders Among Youth
Study Start Date : September 1999
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. condom use [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. scores on HIV knowledge questionnaire [ Time Frame: 1 year ]
  2. number of sexual partners [ Time Frame: 1 year ]
  3. scores on measure of attitudes toward condom use [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603369


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Larry K. Brown/Principal Investigator, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00603369     History of Changes
Other Study ID Numbers: R01MH061149 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009

Keywords provided by Rhode Island Hospital:
HIV prevention
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Mental Disorders
Problem Behavior
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Behavioral Symptoms