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

Primary Purpose

Behavior and Mental Disorders, Methamphetamine Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adolescent Methamphetamine Treament (AMT)
Functional Family Therapy (FFT)
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavior and Mental Disorders focused on measuring methamphetamine abuse

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Oregon Research Institute Center for Family and Adolescent Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Family therapy combined with methamphetamine-specific group treatment.

Family Therapy.

Outcomes

Primary Outcome Measures

Substance Use

Secondary Outcome Measures

Engagement and retention of adolescent methamphetamine users.

Full Information

First Posted
May 16, 2008
Last Updated
August 4, 2014
Sponsor
Oregon Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00680511
Brief Title
Development of a Family-Based Treatment for Adolescent Methamphetamine Use
Acronym
AIMS
Official Title
Development of a Family-Based Treatment for Adolescent Methamphetamine Use
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior and Mental Disorders, Methamphetamine Disorders
Keywords
methamphetamine abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Family therapy combined with methamphetamine-specific group treatment.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Family Therapy.
Intervention Type
Behavioral
Intervention Name(s)
Adolescent Methamphetamine Treament (AMT)
Intervention Description
AMT Group Therapy plus Functional Family Therapy (FFT)
Intervention Type
Behavioral
Intervention Name(s)
Functional Family Therapy (FFT)
Intervention Description
FFT
Primary Outcome Measure Information:
Title
Substance Use
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Engagement and retention of adolescent methamphetamine users.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly B. Waldron, Ph.D.
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute Center for Family and Adolescent Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97205
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ori.org/CFAR/Portland/
Description
Related Info

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Development of a Family-Based Treatment for Adolescent Methamphetamine Use

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