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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
  Purpose

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.


Condition Intervention Phase
HIV/AIDS
 Behavioral: Family-Based HIV prevention
Other: Adolescent Only Health Promotion
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Project RAP: Family-based HIV Prevention in the Juvenile Drug Court

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: December 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
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.
 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.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403298

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

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Sarah Johnson, MA     401-793-8075     sjohnson4@lifespan.org    
Principal Investigator: Marina Tolou-Shams, PhD            
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Marina Tolou-Shams, PhD Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Marina Tolou-Shams, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01403298     History of Changes
Other Study ID Numbers: 5K23DA021532
Study First Received: March 28, 2011
Last Updated: July 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
Adolescent
HIV
AIDS
Sexual risk
Family
 Prevention
Juvenile Drug Court
Juvenile Justice
Drug Use
Marijuana

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013