Trial of Computerized MET for Adolescent Substance Use

This study has been withdrawn prior to enrollment.

(No funding obtained.)

Sponsor:

Information provided by (Responsible Party):

Sion Kim Harris, Children's Hospital Boston

ClinicalTrials.gov Identifier:

NCT01784653

First received: February 4, 2013

Last updated: February 8, 2016

Last verified: February 2016

History of Changes

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 Boston Children’s Hospital:

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.


Enrollment:	0
Study Start Date:	October 2013
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 (Child, Adult)
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

Locations


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

Sponsors and Collaborators

Boston Children’s Hospital

Investigators


Principal Investigator:	Sion K Harris, PhD	Boston Children’s Hospital

More Information


Responsible Party:	Sion Kim Harris, Co-Director, Center for Adolescent Substance Abuse Research, 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 8, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Children’s Hospital:


Substance abuse Drug abuse Alcohol abuse Tobacco Adolescent

Additional relevant MeSH terms:


Tobacco Use Disorder Alcoholism Substance-Related Disorders	Chemically-Induced Disorders Mental Disorders Alcohol-Related Disorders

ClinicalTrials.gov processed this record on September 29, 2016

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