Computerized Screening and Brief Physician Advice to Reduce Teen Drinking

October 6, 2016 updated by: John R Knight, MD, Boston Children's Hospital
The goal of this project is to adapt a computerized Screening and Brief Advice (SBA) protocol that has demonstrated efficacy in reducing underage drinking among adolescent primary care patients and then to test it in a multi-site randomized controlled trial (RCT).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The specific aims of the proposed multisite RCT are:

  1. To establish the efficacy of the computerized SBA protocol on alcohol use, on DWI/RWID, and other alcohol-related health risk behaviors;
  2. To test the effect of Technological Extenders (TE) on prolonging the beneficial effects of the SBA protocol;
  3. To identify moderators, mediators, and optimal responders to the SBA/TE interventions;
  4. To examine the association between cessation of underage drinking and other health-risk behaviors in an adolescent primary care sample.

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
        • Children's Hospital Boston

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 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 12-21 years old
  • patients arriving for routine medical care
  • provide informed assent (for those <18) or informed consent (for those 18-21)

Exclusion Criteria:

  • medically or psychologically unstable at time of visit
  • receiving behavioral health services
  • cannot read or understand English at a 6th grade reading level
  • unavailable for follow-up assessments

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Treatment as Usual (TAU)
Experimental: 2
Computerized Screening and Brief Physician Advice (SBA)
Behavioral: Computerized screening and brief physician advice
Participants complete screening for alcohol use and other health risk behaviors on the computer, receive some related health information on the computer, and meet with a primary care provider for a short discussion of health risk behaviors
Other Names:
  • Brief intervention
  • Screening
  • Brief advice
  • Underage drinking
Experimental: 3
Computerized screening and brief physician advice with technological extenders (SBA/TE)
Behavioral: Computerized SBA with technological extenders
Participants complete screening for alcohol use and other health risk behaviors on the computer, receive some related health information on the computer, and meet with a primary care provider for a short discussion of health risk behaviors. In addition, the provider sends them a brief email or text message at 4 months and 9 months after study entry to reinforce the brief advice.
Other Names:
  • Brief intervention
  • Screening
  • Brief advice
  • Underage drinking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Initiation of underage drinking
Time Frame: Baseline, 3-months, 6-months, 12-months
Baseline, 3-months, 6-months, 12-months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cessation of underage drinking
Time Frame: Baseline, 3-months, 6-months, 12-months
Baseline, 3-months, 6-months, 12-months

Collaborators and Investigators

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

Sponsor

Boston Children's Hospital

Collaborators

Dartmouth-Hitchcock Medical Center
Tufts Medical Center
University of Vermont
Cambridge Health Alliance
Fallon Clinic

Investigators

  • Principal Investigator: John R. Knight, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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, 2010

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

February 23, 2009

First Posted (Estimate)

February 24, 2009

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

  • PA-07-406

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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