- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01521078
Web-based Personalized Feedback for University Students
May 24, 2012 updated by: John Cunningham, Centre for Addiction and Mental Health
Randomized Controlled Trial of a Brief Personalized Feedback Intervention in University Students
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
425
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
-
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Ontario
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Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health
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-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- AUDIT-C score of 4 or more at baseline
Exclusion Criteria:
-
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Provided access to the Check Your Drinking University version (CYDU).
|
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).
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No Intervention: Control
No invention control group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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.
General Publications
- Cunningham JA, Neighbors C, Bertholet N, Hendershot CS. Use of mobile devices to answer online surveys: implications for research. BMC Res Notes. 2013 Jul 8;6:258. doi: 10.1186/1756-0500-6-258.
- Cunningham JA, Hendershot CS, Murphy M, Neighbors C. Pragmatic randomized controlled trial of providing access to a brief personalized alcohol feedback intervention in university students. Addict Sci Clin Pract. 2012 Oct 10;7(1):21. doi: 10.1186/1940-0640-7-21.
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, 2012
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
January 26, 2012
First Submitted That Met QC Criteria
January 26, 2012
First Posted (Estimate)
January 30, 2012
Study Record Updates
Last Update Posted (Estimate)
May 25, 2012
Last Update Submitted That Met QC Criteria
May 24, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAMH#152/2011
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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