- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01511380
Targeting HIV Risk Behaviors in Juvenile Drug Court-Involved Youth
May 3, 2016 updated by: Medical University of South Carolina
This study is designed to gain knowledge about effective interventions for reducing HIV risk in a high risk population.
A new Risk Reduction Therapy for Adolescents (RRTA) will be compared to usual services received by youth in juvenile drug courts.
It is expected that youth treated with RRTA will show greater reductions in substance use and risky sexual behaviors.
Reducing HIV risk by effectively targeting substance use and risky sexual behaviors in high-risk groups such as juvenile drug court-involved youth could favorably impact society at multiple levels (individual, family, peer, community, fiscal).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The overriding purpose of this study is to develop and test an intervention for reducing substance use and risky sexual behaviors among youth involved in juvenile drug court.
Juvenile drug court provides an excellent setting in which to pursue the key study objectives by providing access to a well identified high risk population.
Second, in addition to frequent judicial oversight, juvenile drug courts include several features that can enhance intervention effectiveness, sustainability, and potential for adoption.
In addition, the fact that all juvenile drug courts have community-based treatment components and that such courts have been disseminated nationwide suggests the possibility of eventual widespread adoption if the proposed intervention is effective.
The proposed intervention integrates evidence-based protocols for contingency management (CM) for substance abusing youth and family engagement strategies, with an evidence-informed family systems intervention for sexual risk originally developed to address substance use and sexual risk behaviors in HIV+ youth.
These three interventions will be integrated into an efficient intervention that, if effective, can be amenable to adoption by juvenile drug courts.
Following protocol development and beta testing, 160 drug court youth and their families will be randomized to the experimental intervention condition (Risk Reduction Therapy for Adolescents or "RRTA") versus Drug Court with Community Services (DC) conditions.
Key outcomes will be assessed through 18-months post-baseline using a multi-method approach that will include assessment of substance use, risky sexual behaviors, criminal behavior, and participation in HIV counseling and testing services.
Specific aims include: 1: Adapt existing intervention and training protocols into a single, efficient RRTA intervention, beta test this RRTA protocol with four youth in juvenile drug court and their families, and revise treatment and research protocols accordingly; 2: Conduct a randomized trial with 160 youth in juvenile drug court and their families to examine youth-level intervention effects (i.e., on substance use, sexual risk behavior, HIV counseling and testing, delinquent behavior) in comparison to DC through 18- months post referral and assess intervention fidelity.
3.
If results suggest a positive RRTA treatment effect, revise the intervention and training protocols in preparation for an effectiveness study and extended follow-up study.
Importantly, the proposed study will (1) consider the multiple levels of influence on juvenile drug use, criminal justice involvement, and HIV risk behaviors, (2) integrate a drug abuse and HIV prevention intervention for youth in the criminal justice system with drug-related offenses, (3) address health disparities by targeting a primarily minority population of youth, and (4) increase referrals to HIV testing and counseling of drug court-involved youth.
This study is designed to reduce HIV risk by addressing the potent interaction of drug use and risky sexual behaviors in drug court youth with evidence-based treatment components to maximize the likelihood of reversing these youths' adverse behavioral trajectories.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29401
- Medical University of South Carolina
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- enrolled in juvenile drug court or pre-enrollment status
- residing with permanent caregiver
- youth and caregiver fluent in English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Risk Reduction Therapy for Adolescents
Youth randomly assigned to RRTA will complete a family focused treatment program that will work with the youth and his or her caregiver to help reduce youth substance use and risky sexual behavior using principals of behavior modification and contingency management.
|
This project integrates CM and a family systems intervention for sexual risk with evidence-based family engagement strategies, and tests this intervention in a juvenile drug court setting.
Due to the individualized nature of the proposed intervention, the specific course of treatment will vary by youth and family.
Based on our experience with clinic-based treatment models it is anticipated that most families will remain in active treatment for 4-6 months and that, during this time, they will attend approximately 1-2 sessions per week, for 1-2 hours per session.
|
|
Active Comparator: Usual services
For youth randomly assigned to usual treatment services, the youth will receive the treatment services recommended by the drug court.
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In addition to the standard juvenile drug court requirements, youth randomly assigned to the usual services condition are also ordered to receive treatment services from the local state or privately-funded alcohol and drug treatment provider agencies.
The service delivery model for agencies typically includes intensive outpatient, traditional outpatient, and home-based services, depending upon assessment of youth and family needs.
Groups focus on risk reduction, peer influence, conflict resolution, and anger management.
Additionally, youth might receive treatment pertaining to drug selling behavior, individual sessions and/or family group therapy.
The theoretical orientations of the provider agencies are cognitive-behavioral and systems theory.
Interventions are not usually manual driven, and selection of material is typically left to the therapists' discretion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in substance use frequency
Time Frame: Baseline through 18 months post-baseline
|
Self-reported substance use by the adolescent will be assessed using a variation of the Form 90.
Urine drug screens for cannabis, cocaine, opiates, methamphetamines, and amphetamines will be collected using the "5-Test Integrated Cup" supplied by BioTechNostix.
|
Baseline through 18 months post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in delinquent behavior
Time Frame: Baseline through 18 months post-baseline
|
The 47-item Self-Report Delinquency Scale will be used to tap violent offending, general delinquency, and status offenses.
Archival records maintained by state juvenile justice authorities will be used to examine youths' involvement in the juvenile and adult justice systems.
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Baseline through 18 months post-baseline
|
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Change in sexual risk behaviors
Time Frame: Baseline through 18 months post-baseline
|
The measure of sexual risk behaviors was selected to maximize the likelihood of identifying the highest-risk sexual behaviors.
The Sexual Risk Behavior Scale has been used in previous HIV studies.
This measure will be used to assess participant sexual encounters over the past 3 months and condom use during vaginal and anal sex.
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Baseline through 18 months post-baseline
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Change in frequency of HIV counseling and testing
Time Frame: Baseline through 18 months post-baseline
|
Participation in HIV counseling and testing will be assessed using a standardized set of questionnaire items.
Baseline questions will assess participants' lifetime history of voluntary HIV counseling and testing and identical questions will be re-administered at 6, 12 and 18 months post-baseline to assess whether youth received HIV counseling and testing at any point since the baseline interview.
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Baseline through 18 months post-baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
January 4, 2012
First Submitted That Met QC Criteria
January 12, 2012
First Posted (Estimate)
January 18, 2012
Study Record Updates
Last Update Posted (Estimate)
May 4, 2016
Last Update Submitted That Met QC Criteria
May 3, 2016
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA025880 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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