A Phase 1 interventional study of Family-based HIV prevention program in HIV Infections, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 13 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-20.
Sponsored by Rhode Island Hospital · Phase 1, Interventional, and Prevention
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.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's enrollment of 718 is above the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Parent-child
Behavioral: Family-based HIV prevention program
Adolescent only intervention focusing on condom use skills and assertiveness training around sexual discussions
Behavioral: Family-based HIV prevention program
Health promotion intervention including general health promotion topics such as smoking, diet, exercise, etc.
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
condom use; sexual delay
Time frame: 3 years
parent-adolescent sexual communication
Time frame: 3 years
condom use attitudes
Time frame: 3 years
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Rhode Island Hospital