Trial of Computerized MET for Adolescent Substance Use

Nicotine Dependence Clinical Trial

Official title:

Randomized Controlled Trial of Computerized MET for Adolescent Substance Use

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01784653
• Other study ID #: SKH R01 PA-13-077
• Status: Withdrawn
• Phase: Phase 1
• First received: February 4, 2013
• Last updated: April 10, 2017
• Start date: October 2013

Study information

• Verified date: April 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Drug Abuse
• Nicotine Dependence
• Substance-Related Disorders
• Tobacco Use Disorder

Intervention

Behavioral:
• iMET
Self-completed, computerized motivational enhancement therapy
• MET
Clinician-delivered Motivational Enhancement Therapy

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment process/quality	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
Primary	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.	12 months
Secondary	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.	past-90-days
Secondary	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.	past-90-days
Secondary	HIV Risk Behavior	We will compare group trends in prevalence and frequency of past-90-days HIV Risk Behaviors.	past-90-days