NCT00680511

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2007

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
9 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
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

6 years

First QC Date

May 16, 2008

Last Update Submit

August 4, 2014

Conditions

Keywords

methamphetamine abuse

Outcome Measures

Primary Outcomes (1)

  • Substance Use

    6 months

Secondary Outcomes (1)

  • Engagement and retention of adolescent methamphetamine users.

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Family therapy combined with methamphetamine-specific group treatment.

Behavioral: Adolescent Methamphetamine Treament (AMT)

2

ACTIVE COMPARATOR

Family Therapy.

Behavioral: Functional Family Therapy (FFT)

Interventions

AMT Group Therapy plus Functional Family Therapy (FFT)

1

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

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

BehaviorMental 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

September 1, 2007

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations