Development and Evaluation of Effectiveness of an Internet-based Brief Intervention for Alcohol Use Among Brazilian College Students

February 9, 2018 updated by: André Bedendo, Federal University of São Paulo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46142

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

  • Brazil
      • Sao Paulo, Brazil, 04023062
        • Federal University of São Paulo

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • College students
  • Age 18-30 years
  • Alcohol Use during the last 3 months

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalized Normative Feedback
This group receive the complete Personalized Normative Feedback (with normative information and a list of consequences)
Behavioral: Consequences List Feedback
Behavioral: Personalized Normative Feedback
Experimental: Normative Feedback
This group receive a feedback only with normative informations (without a list of consequences)
Behavioral: Personalized Normative Feedback
Experimental: Consequences List Feedback
This group receive a list of consequences without normative informations
Behavioral: Consequences List Feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Consumption
Time Frame: Last 3 Months
Measured by AUDIT questionnaire
Last 3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Drinks
Time Frame: Last 3 months
Maximum number of drinks reported
Last 3 months
Frequency of Alcohol Use
Time Frame: Last 3 months
Measured by AUDIT questionnaire
Last 3 months
Typical Number of Drinks
Time Frame: Last 3 months
Measured by AUDIT questionnaire
Last 3 months
Number of Alcohol-related Consequences
Time Frame: Last 3 Months
Measured by AUDIT questionnaire
Last 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

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 (Actual)

March 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 6, 2014

First Posted (Estimate)

February 10, 2014

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 9, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNFBrAB2013

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.

Clinical Trials on Alcohol Drinking

Clinical Trials on Consequences List Feedback

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe