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

NCT04499456 | Unknown

• 1 other identifier: 2017/13831-9
• Study Type: interventional
• Target: 685
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (2)

• Typical alcohol use

  The number of typical drink units consumed

  30 days

• Maximum alcohol use

  The number of maximum drink units consumed

  30 days

Secondary Outcomes (3)

• Frequency of alcohol use

  30 days

• Total number of drink units

  30 days

• Number of consequences

  30 days

Study Arms (3)

Control

ACTIVE COMPARATOR

Waiting list control receiving the PNF after the last assessment

Other: Personalised Normative Feedback

Single PNF

EXPERIMENTAL

Receives PNF after the first assessment only

Other: Personalised Normative Feedback

Boosted PNF

EXPERIMENTAL

Receives PNF after every assessment

Other: Personalised Normative Feedback

Interventions

Personalised Normative Feedback 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; Control; Single PNF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Departamento de Psicobiologia

São Paulo, 04023062, Brazil

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: May 18, 2020
• Primary Completion: February 28, 2022
• Study Completion: October 31, 2022
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

BR (1)