Trial of Computerized SBI to Reduce Teen Alcohol Use

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

Randomized Controlled Trial of Computerized SBI to Reduce Teen Alcohol Use

The goal of this project is to test the effectiveness of a computer-facilitated alcohol screening and brief intervention (c-ASBI) system for 12- to 18-year-old primary care patients in a multi-site, randomized comparative effectiveness trial. The investigators hypothesize that, among 12- to 18-year olds patients coming for annual well-care, those receiving c-ASBI will have lower rates of any alcohol use at 3-, 6-, and 12-month follow-ups compared to Treatment As Usual (TAU).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The Specific Aims are to 1) Test the effects of c-ASBI on any alcohol use; 2) Test the effects of c-ASBI separately as a prevention, therapeutic, and risk-reduction intervention; 3) Test the effects of c-ASBI separately on cannabis and tobacco use; explore its effects on other drug use; and 4) Assess potential moderators (e.g., age, gender, race/ethnicity, substance use history +/-, parent/sibling/peer substance use), mediators (e.g., Youth to Provider Connectedness,20 perceived harmfulness of alcohol and drug use), and explore c-ASBI's mechanism of action.

Study Type

Interventional

Phase

  • Phase 1

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, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
      • Boston, Massachusetts, United States, 02115
        • Longwood Pediatrics
      • Boston, Massachusetts, United States, 02128
        • East Boston Neighborhood Health Center
      • Cambridge, Massachusetts, United States, 02139
        • Cambridge Pediatrics
      • Lexington, Massachusetts, United States, 02421
        • Lexington Pediatrics

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

9 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Arriving for well or non-emergent care at one of participating study sites
  • Have an email address
  • Have internet address

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment at Usual
Participants in this group will receive treatment as usual (TAU) from their provider, which may or may not include screening and brief advice regarding alcohol use.
Experimental: c-ASBI
Participants in this group will receive the computerized alcohol screening and brief intervention (c-ASBI).
Behavioral: c-ASBI
Participants in the c-ASBI group will complete a computerized screen for alcohol, cannabis, tobacco and other drugs, then view their screen score and 10 pages of information about the health effects of substance use and true-life stories on the computer. Their provider will see a report of their screen results and provide advice to stop or decrease their use, or, for those at high risk, referral to complete a computerized motivational enhancement therapy intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of alcohol use
Time Frame: 12 months
We will compare rates of any alcohol use over the past twelve months between the groups.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drinking initiation
Time Frame: 12 months
We will compare rates of drinking initiation over the past 12-months between groups.
12 months
Drinking cessation
Time Frame: 12 months
We will compare rates of drinking cessation over the past 12 months between groups.
12 months
Driving/Riding risk
Time Frame: 12 months
We will compare the rates of driving under the influence or riding with a driver under the influence between groups.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannabis use
Time Frame: 12 months
We will compare the rates of cannabis use over the past twelve months between groups.
12 months
Tobacco use
Time Frame: 12 months
We will compare the rates of tobacco use over the past twelve months between groups.
12 months

Collaborators and Investigators

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

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: John R Knight, MD, 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

January 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 6, 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

  • JK R01 PA-12-031

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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