Trial record 9 of 53 for:    child [AGE-GROUP] "drug abuse" | Open Studies

Trial of Computerized MET for Adolescent Substance Use

This study is not yet open for participant recruitment.
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
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 Boston Children's Hospital
  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 April 23, 2014