Back to resultsPreventing HIV/Aids in Drug Abusing Youth
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IBFT /HIV prevention
IBFT
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring substance abuse, HIV risk, Behavior and Mental Disorders, HIV Seronegativity
Eligibility Criteria
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.
Sites / Locations
- Oregon Research Institute Center for Family and Adolescent Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Family Therapy plus HIV prevention
Family Therapy only.
Outcomes
Primary Outcome Measures
Changes in adolescent's substance use.
Secondary Outcome Measures
Changes in HIV risk behaviors.
Full Information
NCT ID
NCT00680719
First Posted
May 16, 2008
Last Updated
August 4, 2014
Sponsor
Oregon Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00680719
Brief Title
Preventing HIV/Aids in Drug Abusing Youth
Official Title
Preventing HIV/Aids in Tx-Resistant Drug-Abusing Youth
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2004 (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
Oregon Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
substance abuse, HIV risk, Behavior and Mental Disorders, HIV Seronegativity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Family Therapy plus HIV prevention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Family Therapy only.
Intervention Type
Behavioral
Intervention Name(s)
IBFT /HIV prevention
Intervention Description
Integrated Behavioral and Family Therapy (IBGT) with HIV prevention.
Intervention Type
Behavioral
Intervention Name(s)
IBFT
Intervention Description
Integrated Behavioral and Family Therapy (IBFT).
Primary Outcome Measure Information:
Title
Changes in adolescent's substance use.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in HIV risk behaviors.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly B Waldron, Ph.D.
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute Center for Family and Adolescent Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Preventing HIV/Aids in Drug Abusing Youth
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