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Trial of Computerized MET for Adolescent Substance Use

Primary Purpose

Drug Abuse, Alcohol Abuse, Nicotine Dependence

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
iMET
MET
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Abuse focused on measuring Substance abuse, Drug abuse, Alcohol abuse, Tobacco, Adolescent

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Treatment as Usual

iMET

MET

Arm Description

Patients will receive the usual care from the treatment program

Participants will complete a self-guided computerized Motivational Enhancement Therapy

Clinician-delivered Motivational Enhancement Therapy

Outcomes

Primary Outcome Measures

Treatment engagement
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.

Secondary Outcome Measures

Days abstinent
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.
Driving/Riding Risk
We will compare group trends in prevalence and frequency of past-90-days Driving while impaired or Riding with an impaired driver.
HIV Risk Behavior
We will compare group trends in prevalence and frequency of past-90-days HIV Risk Behaviors.

Full Information

First Posted
February 4, 2013
Last Updated
April 10, 2017
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01784653
Brief Title
Trial of Computerized MET for Adolescent Substance Use
Official Title
Randomized Controlled Trial of Computerized MET for Adolescent Substance Use
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No funding obtained.
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse, Alcohol Abuse, Nicotine Dependence
Keywords
Substance abuse, Drug abuse, Alcohol abuse, Tobacco, Adolescent

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Patients will receive the usual care from the treatment program
Arm Title
iMET
Arm Type
Experimental
Arm Description
Participants will complete a self-guided computerized Motivational Enhancement Therapy
Arm Title
MET
Arm Type
Experimental
Arm Description
Clinician-delivered Motivational Enhancement Therapy
Intervention Type
Behavioral
Intervention Name(s)
iMET
Intervention Description
Self-completed, computerized motivational enhancement therapy
Intervention Type
Behavioral
Intervention Name(s)
MET
Intervention Description
Clinician-delivered Motivational Enhancement Therapy
Primary Outcome Measure Information:
Title
Treatment engagement
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Days abstinent
Description
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.
Time Frame
past-90-days
Title
Driving/Riding Risk
Description
We will compare group trends in prevalence and frequency of past-90-days Driving while impaired or Riding with an impaired driver.
Time Frame
past-90-days
Title
HIV Risk Behavior
Description
We will compare group trends in prevalence and frequency of past-90-days HIV Risk Behaviors.
Time Frame
past-90-days
Other Pre-specified Outcome Measures:
Title
Treatment process/quality
Description
We will compare completion of the 2 MET sessions, and completion of the third follow-up visit between the iMET and MET conditions.
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sion K Harris, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Trial of Computerized MET for Adolescent Substance Use

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