NCT01784653

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

3.3 years

First QC Date

February 4, 2013

Last Update Submit

April 10, 2017

Conditions

Keywords

Substance abuseDrug abuseAlcohol abuseTobaccoAdolescent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Days abstinent

    past-90-days

  • Driving/Riding Risk

    past-90-days

  • HIV Risk Behavior

    past-90-days

Other Outcomes (1)

  • Treatment process/quality

    60 days

Study Arms (3)

Treatment as Usual

NO INTERVENTION

Patients will receive the usual care from the treatment program

iMET

EXPERIMENTAL

Participants will complete a self-guided computerized Motivational Enhancement Therapy

Behavioral: iMET

MET

EXPERIMENTAL

Clinician-delivered Motivational Enhancement Therapy

Behavioral: MET

Interventions

iMETBEHAVIORAL

Self-completed, computerized motivational enhancement therapy

iMET
METBEHAVIORAL

Clinician-delivered Motivational Enhancement Therapy

MET

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersAlcoholismTobacco Use Disorder

Interventions

histaminol

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Study Officials

  • Sion K Harris, PhD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director, Center for Adolescent Substance Abuse Research

Study Record Dates

First Submitted

February 4, 2013

First Posted

February 6, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2017

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations