Project RAP: Family-based HIV Prevention in the Juvenile Drug Court (Project RAP)
Primary Purpose
HIV/AIDS
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-Based HIV prevention
Adolescent Only Health Promotion
Sponsored by
About this trial
This is an interventional prevention trial for HIV/AIDS focused on measuring Adolescent, HIV, AIDS, Sexual risk, Family, Prevention, Juvenile Drug Court, Juvenile Justice, Drug Use, Marijuana
Eligibility 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
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Adolescent Only Health Promotion
Family-Based HIV prevention
Arm Description
An individual adolescent-only health education program that focuses on risk behaviors related to HIV/AIDS, smoking, diet and exercise
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.
Outcomes
Primary Outcome Measures
adolescent HIV/STD risk
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
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
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.
Full Information
NCT ID
NCT01403298
First Posted
March 28, 2011
Last Updated
May 8, 2020
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01403298
Brief Title
Project RAP: Family-based HIV Prevention in the Juvenile Drug Court
Acronym
Project RAP
Official Title
Project RAP: Family-based HIV Prevention in the Juvenile Drug Court
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Adolescent, HIV, AIDS, Sexual risk, Family, Prevention, Juvenile Drug Court, Juvenile Justice, Drug Use, Marijuana
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adolescent Only Health Promotion
Arm Type
Active Comparator
Arm Description
An individual adolescent-only health education program that focuses on risk behaviors related to HIV/AIDS, smoking, diet and exercise
Arm Title
Family-Based HIV prevention
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Family-Based HIV prevention
Intervention Description
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 Type
Other
Intervention Name(s)
Adolescent Only Health Promotion
Intervention Description
An individual, adolescent-only health education program that focuses on risk behaviors related to HIV/AIDS, smoking, diet and exercise
Primary Outcome Measure Information:
Title
adolescent HIV/STD risk
Description
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
Time Frame
3 months post intervention
Title
adolescent substance use
Description
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.
Time Frame
3 months post-intervention
Secondary Outcome Measure Information:
Title
Scores on measures of parent-child communication (general and sex-specific),parental monitoring and family emotional environment
Description
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.
Time Frame
3 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Tolou-Shams, PhD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Project RAP: Family-based HIV Prevention in the Juvenile Drug Court
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