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

NCT ID: NCT04499456

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

685 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-18

Study Completion Date

2022-10-31

Brief Summary

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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

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Conditions

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Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Waiting list control receiving the PNF after the last assessment

Group Type ACTIVE_COMPARATOR

Personalised Normative Feedback

Intervention Type OTHER

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.

Single PNF

Receives PNF after the first assessment only

Group Type EXPERIMENTAL

Personalised Normative Feedback

Intervention Type OTHER

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.

Boosted PNF

Receives PNF after every assessment

Group Type EXPERIMENTAL

Personalised Normative Feedback

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* College student
* Alcohol use during the last year
* Aged 18 or more years
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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André Bedendo

Sponsor-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Departamento de Psicobiologia

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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André Bedendo, PhD

Role: primary

(011) 2149-0155

Other Identifiers

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2017/13831-9

Identifier Type: -

Identifier Source: org_study_id

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