Clinical trial NCT05639374: Effectiveness of a Peer-led Program to Prevent Alcohol Consumption.
Official title: Effectiveness of a Peer-led Program to Prevent Alcohol Consumption. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Keywords: Peer
Alcohol drinking
Health promotion
Undergraduate
Brief Motivational Intervention
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Asociación de Amigos, Universidad de Navarra
name: Banco Santander
First posted: 2022-12-06
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* University students who are in their first or second year of studies.
* Having had at least one episode of heavy alcohol consumption or binge drinking in the last month.
* Students with availability to attend the intervention.
* Students with mobile phone availability.
* Students who understand and can communicate well in Spanish.

Exclusion Criteria:

* Students who have repeated the course and it is not their first year at the University.
* Students who have previously studied another career.

Primary outcomes:
measure: Change from Baseline total number of alcoholic beverages consumed in a normal week and weekend (including Thursday, Friday and Saturday) at one month.
timeFrame: Baseline, T1 (one month)
measure: Change from Baseline frequency of binge drinking episodes (in the last month), at one month.
timeFrame: Baseline, T1 (one month)
measure: Change from Baseline estimated peak alcohol concentration reached on the occasion of highest consumption, at one month.
timeFrame: Baseline, T1 (one month)
measure: Change from Baseline short-term consequences of alcohol consumption, at one month.
timeFrame: Baseline, T1 (one month)
Secondary outcomes:
measure: Number of Motivational Interviewing micro-skills used by peer counsellors.
timeFrame: Right at the end of training, the last day of training.
measure: Number of topics addressed during the motivational interview.
timeFrame: Right at the end of training, the last day of training.
measure: Qualitative variable: Experience of the peer counselors when carrying out the motivational intervention with their peers.
timeFrame: Right at the end of training, the last day of training.
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: University of Navarra
state: Navarra
Study officials:
affiliation: University of Navarra
name: Navidad Canga Armayor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pilatti A, Read JP, Caneto F. Validation of the Spanish Version of the Young Adult Alcohol Consequences Questionnaire (S-YAACQ). Psychol Assess. 2016 May;28(5):e49-61. doi: 10.1037/pas0000140. Epub 2015 Aug 24.
citation: Dimeff, L.A., Baer, J.S., Kivlahan, D.R., Marlatt, G.A. (1999). Brief Alcohol Screening and Intervention for College Students (BASICS): A Harm Reduction Approach. New York: Guilford Press.
citation: Mastroleo, N. R. (2008). Comparison of Supervision Training Techniques in a Motivational Enhancement Intervention on College Student Drinking [doctoral dissertation].The Pennsylvania State University.
citation: Collins RL, Parks GA, Marlatt GA. Social determinants of alcohol consumption: the effects of social interaction and model status on the self-administration of alcohol. J Consult Clin Psychol. 1985 Apr;53(2):189-200. doi: 10.1037//0022-006x.53.2.189. No abstract available.