NCT00680719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

9 years

First QC Date

May 16, 2008

Last Update Submit

August 4, 2014

Conditions

Keywords

substance abuseHIV riskBehavior and Mental DisordersHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Changes in adolescent's substance use.

    12 months

Secondary Outcomes (1)

  • Changes in HIV risk behaviors.

    12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Family Therapy plus HIV prevention

Behavioral: IBFT /HIV prevention

2

ACTIVE COMPARATOR

Family Therapy only.

Behavioral: IBFT

Interventions

Integrated Behavioral and Family Therapy (IBGT) with HIV prevention.

1
IBFTBEHAVIORAL

Integrated Behavioral and Family Therapy (IBFT).

2

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute Center for Family and Adolescent Research

Portland, Oregon, 97205, United States

Location

MeSH Terms

Conditions

HIV InfectionsSubstance-Related DisordersBehaviorMental Disorders

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesChemically-Induced Disorders

Study Officials

  • Holly B Waldron, Ph.D.

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 20, 2008

Study Start

June 1, 2004

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations