Back to resultsComputerized Screening and Brief Physician Advice to Reduce Teen Drinking
Primary Purpose
Alcohol Abuse, Risk Behavior
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized screening and brief physician advice
Computerized SBA with technological extenders
Sponsored by
About this trial
This is an interventional screening trial for Alcohol Abuse focused on measuring Screening, Brief intervention, Underage drinking
Eligibility 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
Sites / Locations
- Children's Hospital Boston
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Treatment as Usual (TAU)
Computerized Screening and Brief Physician Advice (SBA)
Computerized screening and brief physician advice with technological extenders (SBA/TE)
Outcomes
Primary Outcome Measures
Initiation of underage drinking
Secondary Outcome Measures
Cessation of underage drinking
Full Information
NCT ID
NCT00849589
First Posted
February 23, 2009
Last Updated
October 6, 2016
Sponsor
Boston Children's Hospital
Collaborators
Cambridge Health Alliance, Dartmouth-Hitchcock Medical Center, Fallon Clinic, Tufts Medical Center, University of Vermont
1. Study Identification
Unique Protocol Identification Number
NCT00849589
Brief Title
Computerized Screening and Brief Physician Advice to Reduce Teen Drinking
Official Title
Computerized Screening and Brief Physician Advice to Reduce Teen Drinking
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Grant application was not funded
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Cambridge Health Alliance, Dartmouth-Hitchcock Medical Center, Fallon Clinic, Tufts Medical Center, University of Vermont
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
Detailed Description
The specific aims of the proposed multisite RCT are:
To establish the efficacy of the computerized SBA protocol on alcohol use, on DWI/RWID, and other alcohol-related health risk behaviors;
To test the effect of Technological Extenders (TE) on prolonging the beneficial effects of the SBA protocol;
To identify moderators, mediators, and optimal responders to the SBA/TE interventions;
To examine the association between cessation of underage drinking and other health-risk behaviors in an adolescent primary care sample.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Risk Behavior
Keywords
Screening, Brief intervention, Underage drinking
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Treatment as Usual (TAU)
Arm Title
2
Arm Type
Experimental
Arm Description
Computerized Screening and Brief Physician Advice (SBA)
Arm Title
3
Arm Type
Experimental
Arm Description
Computerized screening and brief physician advice with technological extenders (SBA/TE)
Intervention Type
Behavioral
Intervention Name(s)
Computerized screening and brief physician advice
Other Intervention Name(s)
Screening, Brief advice, Brief intervention, Underage drinking
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Computerized SBA with technological extenders
Other Intervention Name(s)
Screening, Brief advice, Brief intervention, Underage drinking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Initiation of underage drinking
Time Frame
Baseline, 3-months, 6-months, 12-months
Secondary Outcome Measure Information:
Title
Cessation of underage drinking
Time Frame
Baseline, 3-months, 6-months, 12-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R. Knight, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.ceasar.org
Description
Center for Adolescent Substance Abuse Research
Learn more about this trial
Computerized Screening and Brief Physician Advice to Reduce Teen Drinking
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