Effectiveness of a Peer-led Program to Prevent Alcohol Consumption.

NCT05639374 | Completed

• 1 other identifier: CODIGO
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking

Keywords

Peer; Alcohol drinking; Health promotion; Undergraduate; Brief Motivational Intervention

Outcome Measures

Primary Outcomes (4)

• Change from Baseline total number of alcoholic beverages consumed in a normal week and weekend (including Thursday, Friday and Saturday) at one month.

  It will be measured by self-declaration of the participant using the modified version of the Daily Drinking Questionnaire. In this instrument the participant enters each day of the week the number of alcoholic beverages consumed. The greater the number of drinks, the greater the risk of alcohol consumption.

  Baseline, T1 (one month)

• Change from Baseline frequency of binge drinking episodes (in the last month), at one month.

  It will be measured by self-declaration of the participant using a specific closed question. In the case of men it will be: "Think about the last month. How many days have you had 5 or more glasses, pints or glasses of alcoholic beverages on the same occasion of consumption (for example, the same night)?"; and for women: "Think about the last month. How many days have you had 4 or more glasses, pints or glasses of alcoholic beverages on the same occasion of consumption (for example, the same night)? Participants answer the number of days they binge drink. The higher the number, the consumption is more risky.

  Baseline, T1 (one month)

• Change from Baseline estimated peak alcohol concentration reached on the occasion of highest consumption, at one month.

  It will be measured by self-declaration of the participant using the Quantity/Frequency/Peak Index. A self-report measure designed to assess a student's drinking behavior in terms of quantity and frequency of their alcohol consumption on a typical occasion and peak drinking occasion on a given occasion in the past month (number of alcoholic beverages ingested on the occasion of greatest consumption in the last month, and number of hours invested in their consumption). From this information, together with the participant's specific body weight and sex, a computer algorithm is used to estimate the normal and maximum blood alcohol concentration achieved. Blood alcohol levels are calculated as the ratio of milligrams of alcohol per 100 milliliters of blood, and are reported as a percentage. The higher the blood alcohol level, the more alcohol intoxication the participant will have suffered.

  Baseline, T1 (one month)

• Change from Baseline short-term consequences of alcohol consumption, at one month.

  It will be measured by self-declaration of the participant using the Spanish Version of the Young Adult Alcohol Consequences Questionnaire. It is an instrument that seeks to measure the negative consequences associated with alcohol consumption. This tool is made up of 48 items with a dichotomous response format (yes/no), through which the student must respond according to their experience during the last year. In this way, the total score ranges from 0 to 48, the higher the score, the greater the predisposition to develop problems and consequences related to the consumption of alcoholic beverages.

  Baseline, T1 (one month)

Secondary Outcomes (3)

• Number of Motivational Interviewing micro-skills used by peer counsellors.

  Right at the end of training, the last day of training.

• Number of topics addressed during the motivational interview.

  Right at the end of training, the last day of training.

• Qualitative variable: Experience of the peer counselors when carrying out the motivational intervention with their peers.

  Right at the end of training, the last day of training.

Study Arms (2)

BASICS_HealthyClassroom

EXPERIMENTAL

Students assigned to the IG will receive the peer-led preventive program. The preventive program consists of a single face-to-face session, lasting about 45-50 minutes. First, 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". Subsequently, they will have a motivational interview with the counsellor. The content of the intervention will be adapted to the interests and level of motivation of each participant.

Behavioral: BASICS_HealthyClassroom

Control Group

NO INTERVENTION

Students assigned to the CG will not receive any type of intervention, they will only receive the usual information and messages that students receive in their daily environments and at the University.

Interventions

BASICS_HealthyClassroom BEHAVIORAL

First, they will complete a 22-item online questionnaire, collecting all the variables of the research. After completing it, the students in the intervention group will receive personalized feedback by mail that visually summarizes the content of the questionnaire. Students will receive a motivational intervention with the aim of increasing the university's awareness of their alcohol consumption. In the intervention session of the program, the following aspects may be addressed, whenever the participant wishes: 1) Pattern of alcohol consumption of the student; 2) Social norm of alcohol consumption; 3) Negative consequences of alcohol; 4) Costs of alcohol consumption; 5) The change; 6) Specific education on alcohol; and 7) Advice and recommendations.

BASICS_HealthyClassroom

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Asociación de Amigos, Universidad de Navarra: collaborator
• Banco Santander: collaborator

Study Sites (1)

University of Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (5)

• 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.

  PMID: 26302103 BACKGROUND

• 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.

  BACKGROUND

• Mastroleo, N. R. (2008). Comparison of Supervision Training Techniques in a Motivational Enhancement Intervention on College Student Drinking [doctoral dissertation].The Pennsylvania State University.

  BACKGROUND

• 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.

  PMID: 3998247 BACKGROUND

• Lavilla-Gracia M, Pueyo-Garrigues M, Calavia Gil D, Esandi-Larramendi N, Alfaro-Diaz C, Canga-Armayor N. Peer-led BASICS intervention to reduce alcohol consumption and alcohol-related consequences among university students: a randomized controlled trial. Front Public Health. 2023 Oct 31;11:1280840. doi: 10.3389/fpubh.2023.1280840. eCollection 2023.

  PMID: 38026297 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Navidad Canga Armayor, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 6, 2022
• Study Start: November 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 31, 2023
• Last Updated: August 21, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)