Clinical Trials Logo

Clinical Trial Summary

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: - Does a peer-led brief motivational intervention reduce the quantity and frequency of alcohol consumption among university students? - Does a peer-led brief motivational intervention reduce the negative consequences experienced by university students due to alcohol consumption? Participants will: - Complete a baseline online questionnaire (before the intervention) and one month after receiving the intervention. - Participants in the intervention group will receive a brief motivational intervention. Researchers will compare intervention and control group to see if there are statistically significant differences in relation to alcohol consumption.


Clinical Trial Description

STUDY OBJECTIVES Primary Objectives: 1. To evaluate the effectiveness of a peer-led program to prevent alcohol consumption in university students. 2. To compare the effectiveness of said program with a control group that will obtain the usual information and messages that students receive in their daily environments and at the University. Secondary objectives: 1. Evaluate the acquisition by the peer counsellors of the micro-skills of motivational interviewing (MI). 2. Evaluate the adherence of peer counsellors to the content of the program to prevent excessive alcohol consumption. 3. To explore the experience of peer counsellors when carrying out the alcohol consumption prevention intervention with their peers. Program objectives: 1. Decrease the amount of alcohol consumed in a normal week and weekend in students receiving the intervention compared to those in the control group. 2. Reduce episodes of binge drinking in university students who receive the intervention program. 3. Reduce estimated peak blood alcohol concentration (eBAC) in students receiving the intervention program. 4. Reduce the number of negative consequences experienced by the students derived from alcohol consumption. Hypothesis: 1. An educational program, with an emphasis on improving motivation and empowerment, and led by trained peer counsellors, will be more effective in preventing the harmful use of alcohol in university students than the usual health promotion that this population receives. 2. Students in the intervention group will decrease the amount of alcohol consumed in a normal week and weekend compared to those in the control group, and this difference between the two groups will be clinically relevant. 3. The students who receive the intervention will experience fewer episodes of binge drinking compared to the university students in the control group. 4. Students in the intervention group will reduce the estimated peak blood alcohol concentration compared to those in the control group. 5. Students in the intervention group will experience fewer negative consequences from alcohol use compared to those in the control group. 6. Students receiving the intervention will be more motivated to make positive changes in their alcohol risk behaviour compared to the control group. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05639374
Study type Interventional
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact
Status Completed
Phase N/A
Start date November 1, 2022
Completion date July 31, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05414344 - A Brief Intervention for Alcohol Users With Interpersonal Trauma N/A
Completed NCT05521906 - Evaluation of PRYSHM for LGBTQIA2S+ Youth N/A
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Withdrawn NCT04659278 - Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use N/A
Not yet recruiting NCT03632408 - Hangover and Residual Zopiclone Effect on Spatial Perception Phase 1
Completed NCT02718508 - An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use N/A
Active, not recruiting NCT02629679 - Sports, Education and Consumption of Substances in Adolescents N/A
Completed NCT02945371 - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life N/A
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Completed NCT01442753 - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth N/A
Completed NCT01081119 - Brief Voluntary Alcohol and Drug Intervention for Middle School Youth Phase 2
Completed NCT04510116 - Adults In The Making Prevention Trial N/A
Completed NCT00289965 - Substance Use Risk Education (SURE) Project Phase 2
Completed NCT00506753 - Motivation and Skills for Delta-9-tetrahydrocannabinol/Ethanol (THC/ETOH+) Teens in Jail N/A
Recruiting NCT05288790 - Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT Phase 2
Recruiting NCT05620849 - Young Adult Education on Alcohol & Health N/A
Recruiting NCT03588754 - Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking? Phase 2
Recruiting NCT04054466 - Nursing Counseling to the Change of Behavior of Alcohol Consumption in Patients in HAART N/A
Recruiting NCT06074341 - TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study N/A
Terminated NCT04596267 - Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers Phase 1