Project RAP: Family-based HIV Prevention in the Juvenile Drug Court

This study is currently recruiting participants.

Verified July 2011 by Rhode Island Hospital

Sponsor:

Information provided by:

Rhode Island Hospital

ClinicalTrials.gov Identifier:

NCT01403298

First received: March 28, 2011

Last updated: July 26, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 28, 2011

Last Updated Date

July 26, 2011

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

adolescent HIV/STD risk [ Time Frame: 3 months post intervention ] [ Designated as safety issue: No ]
Adolescent self-report of rates of condom use, number of sex partners, number of unprotected vaginal and/or anal intercourse episodes, frequency of alcohol use during sexual activity, frequency of marijuana use during sexual activity, frequency of other drug use during sexual activity
adolescent substance use [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]
Adolescent self-report of quantity and frequency of marijuana use, alcohol use and other drug use over the past 3 months and over the past 30 days. Collateral urine toxicology screen data will also be available for analysis.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01403298 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Scores on measures of parent-child communication (general and sex-specific),parental monitoring and family emotional environment [ Time Frame: 3 months post intervention ] [ Designated as safety issue: No ]

Using well-established parenting and family-based measures, such as the Parental Knowledge scales (for monitoring), Parent-Child Communication Scales (general and sexually-specific), and the Family Assessment Device (FAD), we will be obtaining both parent and adolescent report of these constructs.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Project RAP: Family-based HIV Prevention in the Juvenile Drug Court

Official Title ^ICMJE

Project RAP: Family-based HIV Prevention in the Juvenile Drug Court

Brief Summary

The purpose of this project is to compare the effect of a family-based HIV prevention program to the effect of an adolescent-only health promotion program on adolescent HIV risk and marijuana use among adolescents enrolled in the Juvenile Drug Court (JDC) of the Rhode Island Family Court.

Detailed Description

Adolescents and parents admitted to our study receive either an adolescent-only health education program that focuses on general health risk behaviors related to HIV/AIDS, smoking, diet and exercise or one that focuses on family-based HIV/AIDS education through safe decision-making and control of one's emotions as well as parent-child interactions that are associated with dysregulated affect, subsequent parenting deficits and adolescent HIV risk behaviors.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

HIV/AIDS

Intervention ^ICMJE

Behavioral: Family-Based HIV prevention
This individual, family-based intervention provides sex and HIV/AIDS education as part of a family-based general health education program that focuses on safe decision-making and how to control emotions to stay safe and improve parenting skills.
Other: Adolescent Only Health Promotion
An individual, adolescent-only health education program that focuses on risk behaviors related to HIV/AIDS, smoking, diet and exercise

Study Arm (s)

Active Comparator: Adolescent Only Health Promotion
An individual adolescent-only health education program that focuses on risk behaviors related to HIV/AIDS, smoking, diet and exercise

Intervention: Other: Adolescent Only Health Promotion
Experimental: Family-Based HIV prevention
This individual, family-based intervention provides sex and HIV/AIDS education as part of a family-based general health education program that focuses on safe decision-making and how to control emotions to stay safe and improve parenting skills.

Intervention: Behavioral: Family-Based HIV prevention

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

March 2012

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

13 to 18 years old;
male and female;
in Rhode Island Family Court - Intake and Juvenile Drug Court program;
English speaking

Exclusion Criteria:

HIV infection (by self-report);
history of sex crimes,
current pregnancy

Gender

Both

Ages

13 Years to 18 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Sarah Johnson, M.A.	401-793-8075	sjohnson4@lifespan.org
Contact: Marina Tolou-Shams, PhD	401-444-8539	mtoloushams@lifespan.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01403298

Other Study ID Numbers ^ICMJE

5K23DA021532

Has Data Monitoring Committee

Yes

Responsible Party

Marina Tolou-Shams, Rhode Island Hospital

Study Sponsor ^ICMJE

Rhode Island Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marina Tolou-Shams, PhD

Rhode Island Hospital

Information Provided By

Rhode Island Hospital

Verification Date

July 2011

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

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