Development of a Family-Based Treatment for Adolescent Methamphetamine Use (AIMS)

August 4, 2014 updated by: Oregon Research Institute
The AIMS study compares a methamphetamine-specific treatment intervention to a treatment-as-usual Functional Family Therapy (FFT) approach for adolescents ages 15 to 19. Adolescents are assigned to one of two treatment conditions: (1) 16 weeks of FFT designed to strengthen family relationships and develop skills for helping the adolescent avoid drug use; or (2) 16 weeks of a combination of FFT and a methamphetamine-specific intervention involving group and individual therapy sessions; Families are assessed using questionnaires and interviews, and adolescents participate in neuropsychological testing, before, during, and after treatment to provide information about family functioning, the adolescent's drug use, the adolescent's peers, and other factors that may contribute to treatment success. Adolescents also provide urine specimens for drug screening at assessment visits. Through a partnership with Oregon Health and Science University (OHSU), adolescents will participate in functional magnetic resonance imaging appointments at the hospital to examine regional brain blood flow during tasks designed to measure impulsivity and risk-taking behaviors. As a treatment development grant, study investigators will study adolescents' acceptance of and response to the newly developed methamphetamine-specific treatment approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 15 to 19 years of age.
  • Have at least one parent or parent figure willing to participate.
  • Meet DSM-IV diagnostic criteria for drug-abuse or dependence, including a specific meth use disorder.
  • Reports meth use on at least 5 of the previous 90 days.
  • Have contact with the parent on at least 40% of the past 90 days.
  • With their parent be willing to accept randomization to one of the two treatment interventions.
  • Be willing to participate in the imaging task in the fMRI pilot study.
  • Have basic English competency.
  • Have sufficient residential stability to permit probable contact at follow-up.

Exclusion Criteria:

  • Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures.
  • Have a medical or psychological condition that would preclude undergoing the fMRI scan.
  • Have a sibling who is participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Family therapy combined with methamphetamine-specific group treatment.
Behavioral: Adolescent Methamphetamine Treament (AMT)
AMT Group Therapy plus Functional Family Therapy (FFT)
Active Comparator: 2
Family Therapy.
Behavioral: Functional Family Therapy (FFT)
FFT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Substance Use
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Engagement and retention of adolescent methamphetamine users.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Research Institute

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (Estimate)

May 20, 2008

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA021695

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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