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

Not Applicable

• Conditions: Alcohol Drinking
• Interventions: Other: Personalised Normative Feedback

• Registration Number: NCT04499456
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-18
• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-05
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-02-28
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 685

Inclusion Criteria

• College student
• Alcohol use during the last year
• Aged 18 or more years

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Boosted PNF	Personalised Normative Feedback	Receives PNF after every assessment
Single PNF	Personalised Normative Feedback	Receives PNF after the first assessment only
Control	Personalised Normative Feedback	Waiting list control receiving the PNF after the last assessment

Primary Outcome Measures

Name	Time	Method
Typical alcohol use	30 days	The number of typical drink units consumed
Maximum alcohol use	30 days	The number of maximum drink units consumed

Secondary Outcome Measures

Name	Time	Method
Frequency of alcohol use	30 days
Total number of drink units	30 days
Number of consequences	30 days	The number of consequences

Trial Locations

Locations (1)

Departamento de Psicobiologia; 🇧🇷 São Paulo, Brazil