Mediators and Moderators of a Web-based Intervention for Alcohol Use

Alcohol Drinking Clinical Trial

Official title:

Analysis of Mediators and Moderators of a Web-based Intervention for Alcohol Use Among College Students

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499456
• Other study ID #: 2017/13831-9
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: December 2021
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Alcohol use among college students causes health and social problems. However, even when available, many students do not access alcohol interventions. Web-based Personalized Normative Feedback (PNF) has been used to disseminate alcohol brief-interventions, and evidence supports PNF efficacy in reducing alcohol consumption among this population. On the other hand, studies on PNF mediators and moderators are scarce, limiting the knowledge on the mechanisms of change and conditions in which their effects occur. Objective: to evaluate whether normative perceptions mediate, and motivation to receive the intervention, moderates the effects of a web-based PNF intervention (Pesquisa Universitária sobre Bebidas - PUB 2.0) for alcohol use among Brazilian college students. Methods: Pragmatic randomized controlled trial among college students aged 18 and over and with follow-up assessments after 1, 3 and 6 months. Participants will be randomized into a Control group (assessment only) or to receive the updated version of the intervention (PUB 2.0). Outcomes are the typical number of drinks (primary outcome) and the total number of drinks consumed, drinking frequency, maximum number of drinks consumed and number of consequences (secondary outcomes). Statistical analyses will consider Structural Equation Models and significance level of 5%. This study will improve knowledge on how and in which conditions a web-based alcohol PNF effects occur, helping tailor future strategies to reduce the impact of alcohol problems among college students.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 685
• Est. completion date: October 31, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• College student

• Alcohol use during the last year

• Aged 18 or more years

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Other:
• Personalised Normative Feedback
The Personalised Normative Feedback provides information on 1) alcohol consumption (the number of drinks consumed, alcohol-pattern use, binge drinking); 2) normative comparisons; 3) alcohol-related consequences; 4) practical costs of alcohol consumption (money spent and calories consumed); 5) strategies to avoid or risks associated with alcohol use.

Locations

Country	Name	City	State
Brazil	Departamento de Psicobiologia	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Typical alcohol use	The number of typical drink units consumed	30 days
Primary	Maximum alcohol use	The number of maximum drink units consumed	30 days
Secondary	Frequency of alcohol use		30 days
Secondary	Total number of drink units		30 days
Secondary	Number of consequences	The number of consequences	30 days