NCT01511380

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2013

Enrollment Period

4.8 years

First QC Date

January 4, 2012

Last Update Submit

May 3, 2016

Conditions

Keywords

juvenilerandomized trialsubstance abusesexual riskcontingency management

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline through 18 months post-baseline

Secondary Outcomes (3)

  • Change in delinquent behavior

    Baseline through 18 months post-baseline

  • Change in sexual risk behaviors

    Baseline through 18 months post-baseline

  • Change in frequency of HIV counseling and testing

    Baseline through 18 months post-baseline

Study Arms (2)

Risk Reduction Therapy for Adolescents

EXPERIMENTAL

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.

Behavioral: Risk Reduction Therapy for Adolescents

Usual services

ACTIVE COMPARATOR

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

Behavioral: Usual services

Interventions

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.

Risk Reduction Therapy for Adolescents
Usual servicesBEHAVIORAL

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.

Usual services

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 18, 2012

Study Start

September 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 4, 2016

Record last verified: 2013-05

Locations