HIV Prevention for Youth With Severe Mental Illness

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. Identifier: NCT00496691
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : May 20, 2016
Information provided by (Responsible Party):
Dr. Larry K. Brown, Rhode Island Hospital

July 3, 2007
July 4, 2007
May 20, 2016
April 2002
December 2010   (Final data collection date for primary outcome measure)
condom use; sexual delay [ Time Frame: 3 years ]
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Complete list of historical versions of study NCT00496691 on Archive Site
  • parent-adolescent sexual communication [ Time Frame: 3 years ]
  • condom use attitudes [ Time Frame: 3 years ]
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HIV Prevention for Youth With Severe Mental Illness
HIV Prevention for Youth With Severe Mental Illness
This 4-year competing continuation will extend the follow-up for 750 subjects enrolled in a randomized interventions trial, Project STYLE: "HIV Prevention for Youth with Severe Mental Illness" (R01, MH 63008). Extending the follow-up from one year to 36 months will 1) discern the long-term impact of the Project STYLE interventions and 2) permit complex modeling of the predictors and trajectories of sexual health (delay of sex) and risk (incident STIs). Adolescents, particularly those in mental health treatment, are at risk for HIV because of sexual and substance behaviors. Parent-child communication about sexual topics and parental supervision are associated with delays in the onset of sexual activity and more responsible sexual behavior; thus, the parent project, Project STYLE, is a randomized trial that is evaluating the comparative efficacy of three interventions: a) family-based HIV prevention intervention, b) adolescent-only HIV prevention intervention, and c) general health promotion intervention. This multi-site project (Rhode Island Hospital, Emory University, and the University of Illinois at Chicago) is enrolling an ethnically/racially/geographically diverse group of 750 adolescents in outpatient mental health treatment and their parents. Subjects receive a full day group intervention on the day of randomization, return in two weeks for an individual session, participate in a half day booster session three months later, and are assessed six and 12 months after the intervention. This application offers a unique opportunity to assess this already ascertained sample at three additional points (24,30, and 36 months). This is important because few studies have examined the longer-term predictors of the delay of sex and incident STIs over 36 months using a comprehensive array of family functioning, family monitoring/communication, and trauma history. Additionally, this continuation will provide important data concerning the long-term impact of Project STYLE's theoretically based HIV prevention programs which are designed to maintain safe sexual behaviors. The Family-Based program has increased parent/adolescent sexual communication and reduced adolescent unprotected sex after six months and extended assessment will determine whether these benefits are maintained over time.
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Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
HIV Infections
Behavioral: Family-based HIV prevention program
comparison between parent-child intervention targeting parent-teen sexual communication, condom use skills, and assertiveness training to an adolescent-only intervention that targets similar constructs minus parent-teen sexual communication and a general health promotion intervention
  • Experimental: 1
    Intervention: Behavioral: Family-based HIV prevention program
  • Active Comparator: 2
    Adolescent only intervention focusing on condom use skills and assertiveness training around sexual discussions
    Intervention: Behavioral: Family-based HIV prevention program
  • Placebo Comparator: 3
    Health promotion intervention including general health promotion topics such as smoking, diet, exercise, etc.
    Intervention: Behavioral: Family-based HIV prevention program
Brown LK, Hadley W, Donenberg GR, DiClemente RJ, Lescano C, Lang DM, Crosby R, Barker D, Oster D. Project STYLE: a multisite RCT for HIV prevention among youths in mental health treatment. Psychiatr Serv. 2014 Mar 1;65(3):338-44. doi: 10.1176/

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adolescent in mental health treatment
  • Living with parent/caregiver past 3 months

Exclusion Criteria:

  • Adolescent is HIV positive
  • Adolescent is pregnant
Sexes Eligible for Study: All
13 Years to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH063008 ( U.S. NIH Grant/Contract )
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Dr. Larry K. Brown, Rhode Island Hospital
Rhode Island Hospital
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Principal Investigator: Larry K Brown, MD Rhode Island Hospital/ Brown University
Rhode Island Hospital
January 2015

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