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The goal of this Randomized clinical trial is to evaluate the effectiveness of a peer-led intervention to prevent alcohol consumption in university students. The main questions it aims to answer are:
Participants will:
Researchers will compare intervention and control group to see if there are statistically significant differences in relation to alcohol consumption.
Full description
STUDY OBJECTIVES
Primary Objectives:
Secondary objectives:
Program objectives:
Hypothesis:
STUDY METHODOLOGY
Sample and setting:
In the Randomized Clinical Trial, 306 university students will be randomized to two treatment groups: intervention (IG) and control (CG). The research will be carried out from September 2022 to May 2023 at the University of Navarra (Pamplona). The study population will be made up of first-year university students of the Degree in Nursing, Sciences, Pharmacy and Nutrition, Communication, Law, Economics and Business, Education and Psychology, and Philosophy of a university in the north of Spain, enrolled in the academic year 2022/ 2023.
Study procedure:
The study participants will complete the "BASICS_HealthyClassroom Questionnaire" which is carried out through the "Survey Monkey" platform. This is self-completed in a time of 15 minutes, consists of a total of 22 questions.
Student volunteers who complete the baseline survey and who meet the inclusion criteria will be randomized to one of the two treatment conditions (IG or CG) and will subsequently be contacted by mail to inform them of their selection in the project. Students assigned to the intervention group will receive the peer-led preventive program. The preventive program consists of a single face-to-face session, lasting about 45-50 minutes. In the first place, the participant will receive, from the Research Staff in Training, the individualized feedback sheet prepared from the baseline information obtained through the "BASICS_HealthyClassroom Questionnaire". Later, they will have a motivational interview with the peer counselor (approximately 45 minutes). The content of the intervention will be adapted to the interests and level of motivation of each participant.
The data will be collected in three times. Before the intervention (Time 0; T0), and one month after the intervention (T1).
The peer counselors who carry out the intervention will be fourth-year students from the Faculty of Nursing of the University, who will have previously been trained to carry out the intervention program. The training is being carried out in the first quarter of the 2022-2023 academic year, as part of the optional subject "Motivational Interviewing and Process of Change" of the Faculty of Nursing of the University of Navarra, offered to fourth-year students. . The subject consists of, on the one hand, theoretical classes given by an expert on the subject (10h) and, on the other hand, MI practice workshops and feedback (13h).
The effectiveness of the intervention will be evaluated through the change in the pattern of alcohol consumption, and the negative consequences experienced by each participant.
Recruitment will take place during the month of November (2022) through the transmission of direct information about the project in the first-year undergraduate classes at the faculties involved, and through dissemination on social networks and the website of the University.
The motivational interventions will take place from January to March, when the peer counselors have finished the training.
Enrollment
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Exclusion criteria
Primary purpose
Allocation
Interventional model
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308 participants in 2 patient groups
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Central trial contact
María Lavilla Gracia, MSc; Navidad Canga Armayo, PhD
Data sourced from clinicaltrials.gov
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