Preventing HIV/Aids in Drug Abusing Youth

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680719
• Other study ID #: DA17023
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2008
• Last updated: August 4, 2014
• Start date: June 2004
• Est. completion date: June 2013

Study information

• Verified date: August 2014
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 20 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• IBFT /HIV prevention
Integrated Behavioral and Family Therapy (IBGT) with HIV prevention.
• IBFT
Integrated Behavioral and Family Therapy (IBFT).

Locations

Country	Name	City	State
United States	Oregon Research Institute Center for Family and Adolescent Research	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Research Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in adolescent's substance use.		12 months	No
Secondary	Changes in HIV risk behaviors.		12 months	No