NCT00680576

Brief Summary

The purpose of this study is to find out more about how to provide effective further treatment for adolescents who have received six weeks of group therapy for substance-use problems and continue to use drugs. Treatments used in the study include a group therapy (MET/CBT), an individual therapy (CBT), and a family therapy (FFT). The study will look at whether abstinence or a very low level of use is a better guide for deciding whether further treatment is needed, how well different combinations of treatment work to reduce substance use, and whether it is possible to predict in advance which adolescents will respond best to which types of treatment. Study investigators expect that a treatment strategy using what is learned about these issues in the first half of the project to develop an "adaptive" treatment model will work better than a "fixed" treatment to reduce adolescent substance use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months 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
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 10, 2014

Status Verified

October 1, 2014

Enrollment Period

5.4 years

First QC Date

May 16, 2008

Last Update Submit

October 8, 2014

Conditions

Keywords

adolescent substance abuse

Outcome Measures

Primary Outcomes (1)

  • Urine drug screens

    Pretx, 6, 14 and 22 weeks, 3 and 6 months after initial treatment session

Study Arms (2)

1

ACTIVE COMPARATOR

Eight weeks of individual CBT for adolescents who have completed six weeks of group therapy and continue to use drugs.

Behavioral: CBT, Cognitive Behavioral Therapy

2

ACTIVE COMPARATOR

Eight weeks of FFT for adolescents who have received six weeks of group therapy and continue to use drugs.

Behavioral: FFT, Family Functional Therapy

Interventions

Eight weekly sessions of individual Cognitive Behavioral Therapy, to develop skills enabling adolescents stop or reduce their drug use.

1

Eight weekly sessions of Functional Family Therapy designed to strengthen family relationships and build skills to help the adolescent stop or reduce his/her drug use.

2

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 18 years if age
  • Meet DSM-IV (APA, 1994) diagnostic criteria for substance abuse or dependence
  • Live in the Albuquerque metropolitan area or surrounding communities
  • Sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake).

You may not qualify if:

  • There is evidence of psychotic or organic state of sufficient severity to interfere with the understanding of study instruments and procedures
  • The adolescent is deemed dangerous to self or others during evaluation
  • Services other than outpatient treatment are required for the adolescent (e.g., inpatient, detoxification)
  • Marijuana use is reported as being less than 13% of days in the previous 90 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Res. Inst. Center for Family & Adolescent Research (CFAR)

Albuquerque, New Mexico, 87102, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Holly B Waldron, Ph.D.

    Oregon Research Institute Center for Family and Adolescent Research (ORI/CFAR)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 20, 2008

Study Start

March 1, 2008

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 10, 2014

Record last verified: 2014-10

Locations