Pilot Test of Computerized MET to Reduce Adolescent Alcohol Use

October 6, 2016 updated by: John R Knight, MD, Boston Children's Hospital

Pilot Test of Computerized MET Intervention to Reduce Adolescent Alcohol Use

The goal of this project is to conduct a pilot study evaluating feasibility, acceptability, and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescent primary care patients.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The goal of this project is to conduct a pilot study evaluating feasibility, acceptability, and estimating the effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescent primary care patients. The investigators hypothesize that 1) cMET, when added to Computerized Alcohol Screening and Brief Intervention (cASBI), (cASBI+cMET) will be feasible and acceptable when used in primary care; and 2) 12- to 18-yr old patients receiving cASBI+cMET will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, than cASBI alone.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • any alcohol use days in the past 90 days
  • have an email address and internet access at home, school, or library

Exclusion Criteria:

  • unable to read or understand English
  • living away at college at the time of the recruitment visit
  • not available for computer/telephone follow-ups
  • judged by the provider to be medically or emotionally unstable at time of visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: cASBI+cMET
Participants will complete the computerized alcohol screening and brief intervention (cASBI)protocol at the time of an office visit and also complete the 2-session computerized Motivational Enhancement Therapy intervention (cMET).
Behavioral: cASBI+cMET
In the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit. The cMET protocol is a 2 session intervention composed of 8 exercises designed to encourage adolescents their alcohol and other substance use and develop a plan to stop or reduce their use.
Behavioral: cASBI
In the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit.
ACTIVE_COMPARATOR: cASBI
Participants will complete the computerized screening and brief intervention protocol at the time of a primary care office visit.
Behavioral: cASBI
In the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cMET completion
Time Frame: Baseline
The investigators will measure the percentages of completed cMET sessions by those referred to cMET.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cMET satisfaction
Time Frame: 9 months
The investigators will measure patient satisfaction with the cMET program.
9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol use
Time Frame: 9 months
The investigators will measure rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking in the cASBI+cMET group vs the cASBI group.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2016

Study Completion (ANTICIPATED)

March 1, 2016

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (ESTIMATE)

February 21, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JKR34_PA-13-078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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