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Completed

NCT Number: NCT00496691

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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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Adolescent is HIV positive
  • Adolescent is pregnant

Treatment and study plan

Family-based HIV prevention program

Behavioral

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

Primary outcomes

  1. condom use; sexual delay

    Time frame: 3 years

Secondary outcomes

  1. parent-adolescent sexual communication

    Time frame: 3 years

  2. condom use attitudes

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Registry information

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Jul 4, 2007
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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