Development and Evaluation of Effectiveness of an Internet-based Brief Intervention for Alcohol Use Among Brazilian College Students
1 other identifier
interventional
46,142
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2014
CompletedFirst Posted
Study publicly available on registry
February 10, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 12, 2018
February 1, 2018
3.8 years
February 4, 2014
February 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Alcohol Consumption
Measured by AUDIT questionnaire
Last 3 Months
Secondary Outcomes (4)
Maximum Drinks
Last 3 months
Frequency of Alcohol Use
Last 3 months
Typical Number of Drinks
Last 3 months
Number of Alcohol-related Consequences
Last 3 Months
Study Arms (3)
Personalized Normative Feedback
EXPERIMENTALThis group receive the complete Personalized Normative Feedback (with normative information and a list of consequences)
Normative Feedback
EXPERIMENTALThis group receive a feedback only with normative informations (without a list of consequences)
Consequences List Feedback
EXPERIMENTALThis group receive a list of consequences without normative informations
Interventions
Eligibility Criteria
You may qualify if:
- College students
- Age 18-30 years
- Alcohol Use during the last 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Sao Paulo
São Paulo, 04023062, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc
Study Record Dates
First Submitted
February 4, 2014
First Posted
February 10, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
February 12, 2018
Record last verified: 2018-02