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Web-based Personalized Feedback for University Students

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ClinicalTrials.gov Identifier: NCT01521078
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : May 25, 2012
Sponsor:
Collaborator:
University of Houston
Information provided by (Responsible Party):
John Cunningham, Centre for Addiction and Mental Health

Tracking Information
First Submitted Date  ICMJE January 26, 2012
First Posted Date  ICMJE January 30, 2012
Last Update Posted Date May 25, 2012
Study Start Date  ICMJE January 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2012)
Alcohol Use Disorders Identification Test - Consumption scale (AUDIT-C scale) [ Time Frame: 6 weeks ]
AUDIT-C is a scale that is a composite of three items - frequency of alcohol use, drinks per drinking day, and frequency of 5+ drinking occasions. Scores ranges from 0 to 12 with higher scores indicating more severe alcohol problems.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
AUDIT-C scale [ Time Frame: 6 weeks ]
AUDIT-C is a scale that is a composite of three items - frequency of alcohol use, drinks per drinking day, and frequency of 5+ drinking occasions.
Change History Complete list of historical versions of study NCT01521078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Web-based Personalized Feedback for University Students
Official Title  ICMJE Randomized Controlled Trial of a Brief Personalized Feedback Intervention in University Students
Brief Summary Excessive alcohol consumption in university students continues for be a serious public health concern with a variety of negative consequences. There have been a number of different brief interventions developed to address this issue among university students. The current project will add to this literature by evaluating the use of a personalized feedback intervention (www.CheckYourDrinkingU.net; CYDU). Specifically, this trial will examine whether providing access to the CYDU will result in short-term reductions in drinking. This issue is important as use of these interventions is not a mandatory requirement for university students so the issue is whether making materials of this type available leads to any reductions in risky drinking. It is hypothesized that students provided access to the CYDU will display greater reductions in drinking at a six-week follow-up as compared to students who were not provided access to the CYDU.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Risky Alcohol Consumption
Intervention  ICMJE Behavioral: Check Your Drinking University version
The CYDU is an internet-based intervention that provides a personalized feedback summary which compares the participant's drinking to that of other university students. The CYDU is a modified version of the Check Your Drinking screener which has been validated in four separate randomized controlled trials. The primary modification of the CYDU is that the population norms used for comparison are those of university students (in the USA or Canada).
Study Arms  ICMJE
  • Experimental: Intervention
    Provided access to the Check Your Drinking University version (CYDU).
    Intervention: Behavioral: Check Your Drinking University version
  • No Intervention: Control
    No invention control group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 24, 2012)
425
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2012)
1000
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • AUDIT-C score of 4 or more at baseline

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01521078
Other Study ID Numbers  ICMJE CAMH#152/2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Cunningham, Centre for Addiction and Mental Health
Study Sponsor  ICMJE Centre for Addiction and Mental Health
Collaborators  ICMJE University of Houston
Investigators  ICMJE Not Provided
PRS Account Centre for Addiction and Mental Health
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP