Back to resultsDevelopment and Evaluation of Effectiveness of an Internet-based Brief Intervention for Alcohol Use Among Brazilian College Students
Primary Purpose
Alcohol Drinking
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Consequences List Feedback
Personalized Normative Feedback
Sponsored by
About this trial
This is an interventional health services research trial for Alcohol Drinking
Eligibility Criteria
Inclusion Criteria:
- College students
- Age 18-30 years
- Alcohol Use during the last 3 months
Exclusion Criteria:
-
Sites / Locations
- Federal University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Personalized Normative Feedback
Normative Feedback
Consequences List Feedback
Arm Description
This group receive the complete Personalized Normative Feedback (with normative information and a list of consequences)
This group receive a feedback only with normative informations (without a list of consequences)
This group receive a list of consequences without normative informations
Outcomes
Primary Outcome Measures
Alcohol Consumption
Measured by AUDIT questionnaire
Secondary Outcome Measures
Maximum Drinks
Maximum number of drinks reported
Frequency of Alcohol Use
Measured by AUDIT questionnaire
Typical Number of Drinks
Measured by AUDIT questionnaire
Number of Alcohol-related Consequences
Measured by AUDIT questionnaire
Full Information
NCT ID
NCT02058355
First Posted
February 4, 2014
Last Updated
February 9, 2018
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02058355
Brief Title
Development and Evaluation of Effectiveness of an Internet-based Brief Intervention for Alcohol Use Among Brazilian College Students
Official Title
Development and Evaluation of Effectiveness of an Internet-based Brief Intervention for Alcohol Use Among Brazilian College Students
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
5. Study Description
Brief Summary
This project aims to develop and evaluate the effectiveness of an Personalized Normative Feedback (PNF) intervention via the internet, through a randomized clinical trial for alcohol consumption among Brazilian college students, as well as evaluating the most effective components of the PNF (normative and list of consequences). The sample is composed of college students aged between 18 and 30 years. Participants allocated into four different groups: control, full intervention (PNF), feedback with normative components (FN) and feedback with list of consequences (FLC). The investigators will use the dismantling design to study the most effective components. Participants will be followed-up at 1, 3 and 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Personalized Normative Feedback
Arm Type
Experimental
Arm Description
This group receive the complete Personalized Normative Feedback (with normative information and a list of consequences)
Arm Title
Normative Feedback
Arm Type
Experimental
Arm Description
This group receive a feedback only with normative informations (without a list of consequences)
Arm Title
Consequences List Feedback
Arm Type
Experimental
Arm Description
This group receive a list of consequences without normative informations
Intervention Type
Behavioral
Intervention Name(s)
Consequences List Feedback
Intervention Type
Behavioral
Intervention Name(s)
Personalized Normative Feedback
Primary Outcome Measure Information:
Title
Alcohol Consumption
Description
Measured by AUDIT questionnaire
Time Frame
Last 3 Months
Secondary Outcome Measure Information:
Title
Maximum Drinks
Description
Maximum number of drinks reported
Time Frame
Last 3 months
Title
Frequency of Alcohol Use
Description
Measured by AUDIT questionnaire
Time Frame
Last 3 months
Title
Typical Number of Drinks
Description
Measured by AUDIT questionnaire
Time Frame
Last 3 months
Title
Number of Alcohol-related Consequences
Description
Measured by AUDIT questionnaire
Time Frame
Last 3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
College students
Age 18-30 years
Alcohol Use during the last 3 months
Exclusion Criteria:
-
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04023062
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Development and Evaluation of Effectiveness of an Internet-based Brief Intervention for Alcohol Use Among Brazilian College Students
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