Trial of Computerized MET for Adolescent Substance Use

April 10, 2017 updated by: Sion Kim Harris, Boston Children's Hospital

Randomized Controlled Trial of Computerized MET for Adolescent Substance Use

The purpose of this study is to test the effects of a computerized, self-directed Motivational Enhancement Therapy program for adolescent substance use (iMET), in comparison to clinician-delivered MET and Treatment As Usual (TAU), on treatment engagement and substance use. The investigators hypothesize that both iMET and MET will be more effective than TAU in engaging/retaining patients in treatment and in reducing substance use during a 12-month follow-up period. The investigators also hypothesize that Self-directed iMET will be as effective as the clinician-guided MET in increasing treatment engagement and abstinence during the 12-months follow-up period.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

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

10 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • completed initial visit at the treatment program;
  • be available to return for iMET/MET sessions (if assigned)
  • be available to complete all follow-up measurements
  • a past-12-month CRAFFT score >1
  • have used substances on >6 days (not including tobacco use) during the 90 days preceding their visit

Exclusion Criteria:

  • unable to speak and understand English, or read English at a 5th grade reading level
  • youth deemed by the clinical team to require immediate hospitalization or referral to more intensive residential treatment

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
No Intervention: Treatment as Usual
Patients will receive the usual care from the treatment program
Experimental: iMET
Participants will complete a self-guided computerized Motivational Enhancement Therapy
Behavioral: iMET
Self-completed, computerized motivational enhancement therapy
Experimental: MET
Clinician-delivered Motivational Enhancement Therapy
Behavioral: MET
Clinician-delivered Motivational Enhancement Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment engagement
Time Frame: 12 months
We will compare the number of individual visits in the program, the number of group sessions completed, and the number of urine screens completed during a 12 month follow-up period by each participant in the three study arms.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days abstinent
Time Frame: past-90-days
We will calculate the past-90-days number of days abstinent from any substance use and from the primary substance and the number of weeks abstinent from any substance use.
past-90-days
Driving/Riding Risk
Time Frame: past-90-days
We will compare group trends in prevalence and frequency of past-90-days Driving while impaired or Riding with an impaired driver.
past-90-days
HIV Risk Behavior
Time Frame: past-90-days
We will compare group trends in prevalence and frequency of past-90-days HIV Risk Behaviors.
past-90-days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment process/quality
Time Frame: 60 days
We will compare completion of the 2 MET sessions, and completion of the third follow-up visit between the iMET and MET conditions.
60 days

Collaborators and Investigators

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

Sponsor

Boston Children's Hospital

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

October 1, 2013

Primary Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 6, 2013

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKH R01 PA-13-077

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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