Methods: a randomized controlled trial with a dismantling design to study the most effective components of the PNF. Participants are allocated into four different groups: control (waiting list), full intervention (PNF), feedback with only normative components and feedback with only a list of consequences. Participants will be followed up at 1, 3 and 6 months. Inclusion criteria are: 18 to 30 years, college students and AUDIT-C ≥4 for men and ≥3 for women. Questionnaire includes sociodemographic questions, AUDIT, Rutgers Alcohol Problem Index (RAPI). Students from all Brazilian states are being recruited through email invitations. All intervention (questionnaire and feedback reading) take about 5 to 10 minutes and participants can print or send their feedbacks to personal emails to further consultation. Invitations started at October/2014 and will occur until March/2015 with each subject receiving up to 5 invitations.
Results: To date, 334 students opened the email, 65 (19.5%) accessed the website and 52 participants were eligible for the trial. Mean age of 21.7 years (SE: 0.40), 51.9% are male and 63.5% are students from private institutions. AUDIT mean score were 19.6 (95%CI: 18.2-21.0) and 67.3% of students reported at least one binge drinking episode during last month. Future analyses include logistic regression models and comparisons of the different intervention groups.
Discussion/Conclusion: Due to a small sample, results are yet limited, and a low response rate is also observed. This study do not include financial incentives, which may improve response rate. Younger people also are less likely to demonstrate adherence internet-based intervention compared to older subjects. Further strategies could include additional recruitment approaches. This trial will provide information regarding the effectiveness of an internet-based PNF intervention for Brazilian college students and if there is any difference between different components of the intervention.
Clinical Trial Identifier: NCT02058355.