Preventing HIV/Aids in Drug Abusing Youth

This study has been completed.

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Oregon Research Institute

ClinicalTrials.gov Identifier:

NCT00680719

First received: May 16, 2008

Last updated: August 4, 2014

Last verified: August 2014

History of Changes

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 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Preventing HIV/Aids in Tx-Resistant Drug-Abusing Youth

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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 ]


Enrollment:	111
Study Start Date:	June 2004
Study Completion Date:	June 2013
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	15 Years to 20 Years (Child, Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680719

Locations


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

Sponsors and Collaborators

Oregon Research Institute

National Institute on Drug Abuse (NIDA)

Investigators


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

More Information


Responsible Party:	Oregon Research Institute
ClinicalTrials.gov Identifier:	NCT00680719 History of Changes
Other Study ID Numbers:	DA17023
Study First Received:	May 16, 2008
Last Updated:	August 4, 2014
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:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 26, 2016

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