HIV Prevention for Youth With Severe Mental Illness

NCT ID: NCT00496691

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 718 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2010-12-31

Brief Summary

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Parent-child

Group Type: EXPERIMENTAL

Family-based HIV prevention program

Intervention Type: 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

2

Adolescent only intervention focusing on condom use skills and assertiveness training around sexual discussions

Group Type: ACTIVE_COMPARATOR

Family-based HIV prevention program

Intervention Type: 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

3

Health promotion intervention including general health promotion topics such as smoking, diet, exercise, etc.

Group Type: PLACEBO_COMPARATOR

Family-based HIV prevention program

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Adolescent is HIV positive
• Adolescent is pregnant

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Larry K. Brown

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larry K Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital/ Brown University

Locations

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

References

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/appi.ps.201300095.

Reference Type: DERIVED

PMID: 24382603 (View on PubMed)

Other Identifiers

R01MH063008

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01-MH63008-5

Identifier Type: -

Identifier Source: org_study_id