Computerized Screening and Brief Physician Advice to Reduce Teen Drinking

This study has been withdrawn prior to enrollment.
(Grant application was not funded)
Sponsor:
Collaborators:
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
First received: February 23, 2009
Last updated: March 7, 2011
Last verified: March 2011
  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
Alcohol Abuse
Risk Behavior
Behavioral: Computerized screening and brief physician advice
Behavioral: Computerized SBA with technological extenders

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
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
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:
  • Screening
  • Brief advice
  • Brief intervention
  • 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:
  • Screening
  • Brief advice
  • Brief intervention
  • Underage drinking

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: Dr. John R. Knight, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00849589     History of Changes
Other Study ID Numbers: PA-07-406
Study First Received: February 23, 2009
Last Updated: March 7, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014