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Targeting HIV Risk Behaviors in Juvenile Drug Court-Involved Youth

Primary Purpose

Substance Use, Sexual Risk Behaviors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Risk Reduction Therapy for Adolescents
Usual services
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use focused on measuring juvenile, randomized trial, substance abuse, sexual risk, contingency management

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • enrolled in juvenile drug court or pre-enrollment status
  • residing with permanent caregiver
  • youth and caregiver fluent in English

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Risk Reduction Therapy for Adolescents

Usual services

Arm Description

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.

For youth randomly assigned to usual treatment services, the youth will receive the treatment services recommended by the drug court.

Outcomes

Primary Outcome Measures

Change in substance use frequency
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.

Secondary Outcome Measures

Change in delinquent behavior
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.
Change in sexual risk behaviors
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.
Change in frequency of HIV counseling and testing
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.

Full Information

First Posted
January 4, 2012
Last Updated
May 3, 2016
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01511380
Brief Title
Targeting HIV Risk Behaviors in Juvenile Drug Court-Involved Youth
Official Title
Targeting HIV Risk Behaviors in Juvenile Drug Court-Involved Youth
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (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
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Sexual Risk Behaviors
Keywords
juvenile, randomized trial, substance abuse, sexual risk, contingency management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Risk Reduction Therapy for Adolescents
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual services
Arm Type
Active Comparator
Arm Description
For youth randomly assigned to usual treatment services, the youth will receive the treatment services recommended by the drug court.
Intervention Type
Behavioral
Intervention Name(s)
Risk Reduction Therapy for Adolescents
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual services
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in substance use frequency
Description
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.
Time Frame
Baseline through 18 months post-baseline
Secondary Outcome Measure Information:
Title
Change in delinquent behavior
Description
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.
Time Frame
Baseline through 18 months post-baseline
Title
Change in sexual risk behaviors
Description
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.
Time Frame
Baseline through 18 months post-baseline
Title
Change in frequency of HIV counseling and testing
Description
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.
Time Frame
Baseline through 18 months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: enrolled in juvenile drug court or pre-enrollment status residing with permanent caregiver youth and caregiver fluent in English
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States

12. IPD Sharing Statement

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Targeting HIV Risk Behaviors in Juvenile Drug Court-Involved Youth

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