- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680719
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
Intervention / Treatment
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
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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.
Sponsor
Collaborators
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA17023
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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