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

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058355
• Other study ID #: PNFBrAB2013
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: February 9, 2018
• Start date: March 2014
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46142
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• College students

• Age 18-30 years

• Alcohol Use during the last 3 months

Exclusion Criteria:

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Behavioral:
• Consequences List Feedback

• Personalized Normative Feedback

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Consumption	Measured by AUDIT questionnaire	Last 3 Months
Secondary	Maximum Drinks	Maximum number of drinks reported	Last 3 months
Secondary	Frequency of Alcohol Use	Measured by AUDIT questionnaire	Last 3 months
Secondary	Typical Number of Drinks	Measured by AUDIT questionnaire	Last 3 months
Secondary	Number of Alcohol-related Consequences	Measured by AUDIT questionnaire	Last 3 Months