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Computerized Screening and Brief Physician Advice to Reduce Teen Drinking
This study is not yet open for participant recruitment.
Verified by Children's Hospital Boston, August 2009
First Received: February 23, 2009   Last Updated: August 20, 2009   History of Changes
Sponsors and Collaborators: Children's Hospital Boston
Cambridge Health Alliance
Dartmouth-Hitchcock Medical Center
Fallon Clinic
Tufts Medical Center
University of Vermont
Information provided by: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00849589
  Purpose

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).


Condition Intervention
Underage Drinking
Adolescent Health Risk Behaviors
Behavioral: Computerized screening and brief physician advice
Behavioral: Computerized SBA with technological extenders

Study Type: Interventional
Study Design: Screening, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Computerized Screening and Brief Physician Advice to Reduce Teen Drinking

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Initiation of underage drinking [ Time Frame: Baseline, 3-months, 6-months, 12-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cessation of underage drinking [ Time Frame: Baseline, 3-months, 6-months, 12-monts ] [ Designated as safety issue: No ]

Estimated Enrollment: 3100
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
Treatment as Usual (TAU)
2: Experimental
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
3: Experimental
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.

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.
  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849589

Contacts
Contact: John R. Knight, MD 617-355-5433 john.knight@childrens.harvard.edu
Contact: Shari Van Hook, MPH 617-355-5433 shari.vanhook@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Cambridge Health Alliance
Dartmouth-Hitchcock Medical Center
Fallon Clinic
Tufts Medical Center
University of Vermont
Investigators
Principal Investigator: John R. Knight, MD Children's Hospital Boston
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Hospital Boston ( Dr. John R. Knight )
Study ID Numbers: PA-07-406
Study First Received: February 23, 2009
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00849589     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Screening
Brief intervention
Underage drinking

Study placed in the following topic categories:
Ethanol

ClinicalTrials.gov processed this record on August 30, 2009