Preventing HIV/Aids in Drug Abusing Youth

August 4, 2014 updated by: Oregon Research Institute

Preventing HIV/Aids in Tx-Resistant Drug-Abusing Youth

This project involves two studies focusing on the engagement and treatment of adolescents diagnosed with substance use disorders. Study 1 will evaluate a promising parent-based engagement intervention, Community Reinforcement Training, designed to facilitate the entry of resistant drug-abusing adolescents in treatment. The approach will be compared with an Engagement As Usual intervention condition. Study 2 involves a controlled clinical trial evaluating the efficacy of an HIV/AIDS prevention intervention embedded in family-based drug abuse treatment for reducing HIV/AIDS risk behaviors and substance use. Adolescents who are successfully engaged in treatment through Study 1 will be randomly assigned to receive either family therapy alone or family therapy with the integrated HIV/AIDS prevention intervention. Both studies are being conducted in Portland, Oregon.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 1

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

    • Oregon
      • Portland, Oregon, United States, 97205
        • Oregon Research Institute Center for Family and Adolescent Research

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

15 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parents have an adolescent in the ages of 15-20 years.
  • Have had contact with the adolescent on at least 40% of the past 90 days.
  • Have some knowledge or evidence that the adolescent would meet DSM-IV diagnostic criteria for a substance abuse disorder.
  • Adolescent has explicitly refused to attend any intake or therapy sessions.
  • All parents' efforts to enter adolescent into treatment have failed, despite therapist's assistance.
  • Residence in Portland vicinity.
  • Sufficient residential stability to permit probable contact at follow-up. (e.g. not homeless at time of intake)

Exclusion Criteria:

  • Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures.
  • Adolescent has received residential drug treatment longer than a 2-week period in the past 90 days.

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
Active Comparator: 1
Family Therapy plus HIV prevention
Integrated Behavioral and Family Therapy (IBGT) with HIV prevention.
Active Comparator: 2
Family Therapy only.
Integrated Behavioral and Family Therapy (IBFT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in adolescent's substance use.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in HIV risk behaviors.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Holly B Waldron, Ph.D., Oregon Research Institute

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

June 1, 2004

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (Estimate)

May 20, 2008

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

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.

Clinical Trials on HIV Infections

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