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

This study has been completed.
Sponsor:
Information provided by:
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00603369
First received: January 16, 2008
Last updated: February 5, 2009
Last verified: February 2009

January 16, 2008
February 5, 2009
September 1999
December 2007   (final data collection date for primary outcome measure)
condom use [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00603369 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
HIV, Abuse, and Psychiatric Disorders Among Youth
HIV, Abuse, and Psychiatric Disorders Among Youth

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Behavioral: group intervention
    13-session intervention
  • Behavioral: group intervention
    2-session intervention
  • Experimental: 1
    13 session group intervention including sexual health information, affect management skills, cognitive monitoring, and communication skills training.
    Intervention: Behavioral: group intervention
  • Active Comparator: 2
    2 session group intervention including sexual health information training.
    Intervention: Behavioral: group intervention
Brown LK, Nugent NR, Houck CD, Lescano CM, Whiteley LB, Barker D, Viau L, Zlotnick C. Safe Thinking and Affect Regulation (STAR): human immunodeficiency virus prevention in alternative/therapeutic schools. J Am Acad Child Adolesc Psychiatry. 2011 Oct;50(10):1065-74. Epub 2011 Aug 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
212
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
13 Years to 19 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00603369
R01 MH061149, R01 MH061149
Yes
Larry K. Brown/Principal Investigator, Rhode Island Hospital
Rhode Island Hospital
Not Provided
Principal Investigator: Larry K. Brown, MD Rhode Island Hospital
Rhode Island Hospital
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP