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

Federal University of São Paulo

Status: Unknown

Conditions: Alcohol Drinking

Treatments: Other: Personalised Normative Feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04499456

2017/13831-9

Details and patient eligibility

About

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.

Enrollment: 685 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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685 participants in 3 patient groups

Control

Active Comparator group

Description:

Waiting list control receiving the PNF after the last assessment

Treatment:

Other: Personalised Normative Feedback

Single PNF

Experimental group

Description:

Receives PNF after the first assessment only

Treatment:

Other: Personalised Normative Feedback

Boosted PNF

Experimental group

Description:

Receives PNF after every assessment

Treatment:

Other: Personalised Normative Feedback