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Preventing HIV/Aids in Drug Abusing Youth
This study is currently recruiting participants.
Verified by Oregon Research Institute, February 2010
First Received: May 16, 2008   Last Updated: February 2, 2010   History of Changes
Sponsor: Oregon Research Institute
Collaborator: National Institute on Drug Abuse (NIDA)
Information provided by: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00680719
  Purpose

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.


Condition Intervention Phase
HIV Infections
Behavioral: IBFT /HIV prevention
Behavioral: IBFT
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Preventing HIV/Aids in Tx-Resistant Drug-Abusing Youth

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Changes in adolescent's substance use. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in HIV risk behaviors. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: June 2004
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Family Therapy plus HIV prevention
Behavioral: IBFT /HIV prevention
Integrated Behavioral and Family Therapy (IBGT) with HIV prevention.
2: Active Comparator
Family Therapy only.
Behavioral: IBFT
Integrated Behavioral and Family Therapy (IBFT).

  Eligibility

Ages Eligible for Study:   15 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680719

Contacts
Contact: Erica Finstad, Ph.D. 503-243-1065 efinstad@ori.org

Locations
United States, Oregon
Oregon Research Institute Center for Family and Adolescent Research Recruiting
Portland, Oregon, United States, 97205
Contact: Erica Finstad, Ph.D.     503-243-1065     efinstad@ori.org    
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Holly B Waldron, Ph.D. Oregon Research Institute
  More Information

No publications provided

Responsible Party: Oregon Research Institute ( Holly Barrett Waldron, Ph.D. )
Study ID Numbers: DA17023
Study First Received: May 16, 2008
Last Updated: February 2, 2010
ClinicalTrials.gov Identifier: NCT00680719     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Research Institute:
substance abuse
HIV risk
Behavior and Mental Disorders
HIV Seronegativity

Additional relevant MeSH terms:
Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010