Trial of Computerized MET for Adolescent Substance Use

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01784653
First received: February 4, 2013
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Drug Abuse
Alcohol Abuse
Nicotine Dependence
Behavioral: iMET
Behavioral: MET
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Computerized MET for Adolescent Substance Use

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Treatment engagement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: past-90-days ] [ Designated as safety issue: No ]
    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 [ Time Frame: past-90-days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: past-90-days ] [ Designated as safety issue: No ]
    We will compare group trends in prevalence and frequency of past-90-days HIV Risk Behaviors.


Other Outcome Measures:
  • Treatment process/quality [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    We will compare completion of the 2 MET sessions, and completion of the third follow-up visit between the iMET and MET conditions.


Estimated Enrollment: 375
Study Start Date: October 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784653

Contacts
Contact: Sion K Harris, PhD 857-218-4304 sion.harris@childrens.harvard.edu
Contact: Shari Van Hook, MPH 857-218-4317 shari.vanhook@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Sion K Harris, PhD         
Sub-Investigator: John R Knight, MD         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Sion K Harris, PhD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01784653     History of Changes
Other Study ID Numbers: SKH R01 PA-13-077
Study First Received: February 4, 2013
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Substance abuse
Drug abuse
Alcohol abuse
Tobacco
Adolescent

Additional relevant MeSH terms:
Substance-Related Disorders
Tobacco Use Disorder
Alcoholism
Mental Disorders
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on July 28, 2014