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Peer-led Brief Alcohol Intervention for College Student Drinkers in Spain

Primary Purpose

Peer Group, Motivational Interviewing, Cognitive Behavioral Therapy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Peer-led BASICS
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peer Group focused on measuring Brief interventions, Motivational interviewing, Peer counsellors, College students, Alcohol, Counsellor behavior

Eligibility Criteria

18 Years - 20 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • First year university students of Nursing Degree, between 18 and 20 years old.
  • Students of first access to the University.
  • Having had at least one episode of heavy drinking or binge drinking in the past month.

Exclusion Criteria:

  • Students who have started or previously studied other university degrees or a higher degree.
  • University students who do not consume alcohol or, if they do consume alcohol, have not had binge drinking in the last month.

Sites / Locations

  • University of Navarra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group: peer-led BASICS session

Control group

Arm Description

Participants randomized to the intervention group received a peer-led BASICS session.

Participants randomized to the control group did not receive any specific intervention.

Outcomes

Primary Outcome Measures

Change in 'Quantitaty of alcohol use in a typical weekend' (preliminary efficacy outcomes)
Assesing the change in the total number of drinks during a typical weekend (Thursday, Friday, Saturday and Sunday) during the previous 30 days.
Change in 'Estimated peak blood alcohol content (peak BAC)' (preliminary efficacy outcomes)
Assesing the change in the estimated peak blood alcohol content. It was calculated using participants' responses about maximum drinks consumed on the occasion of highest consumption in the last month, and the number of hours they spent drinking on that occasion.
Change in 'Frequency of binge drinking episodes' (preliminary efficacy outcomes)
Assesing the change in the frequency of binge drinking episodes in the past month (5 or more (male)/ 4 or more (female) glasses of alcoholic beverages on the same drinking occasion).
Change in 'Number of alcohol-related consequences (preliminary efficacy outcomes)'
Assesing the change in the number of negative consequences associated with their alcohol consumption in the previous 30 days.

Secondary Outcome Measures

Peer counselors' fidelity -adherence to motivational interviewing skills and alcohol-related content (feasibility outcomes)
Peer counselors' fidelity to the implementation of the intervention, including adherence to the theoretical alchol-related content, and the use of MI skills during the intervention. For their measurement, an alcohol-related content checklist and the Peer Proficiency Assessment were used.
Barriers and facilitators of the implementation process (feasibility outcomes)
Factors that have affected positively and negatively during the program implementation.
Acceptability -satisfaction- (feasibility outcomes)
Satisfaction of both participants and peer counsellors with the program. It was used and ad-hoc questionnaire

Full Information

First Posted
June 16, 2022
Last Updated
June 23, 2022
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT05437484
Brief Title
Peer-led Brief Alcohol Intervention for College Student Drinkers in Spain
Official Title
Design, Implementation and Evaluation of a Peer-led Alcohol Prevention Intervention for College Students. A Exploratory Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A pilot randomized controlled trial was carried out. Fifty nursing students were randomly assigned either a 50-minute brief motivational intervention with individual feedback or a treatment-as-usual control condition. The intervention was delivered by undergraduate peer counsellors trained in Brief Alcohol Screening and Intervention for College Students. Primary outcomes for testing efficacy were alcohol use and alcohol-related consequences.
Detailed Description
Aims: To assess the potential efficacy and the feasibility of a peer-led brief alcohol intervention aimed to reduce the alcohol consumption in Spanish heavy nursing student drinkers. Methods: A pilot randomized controlled trial was carried out. Fifty nursing students were randomly assigned either a 50-minute brief motivational enhancement intervention with individual feedback (n=23) or a treatment-as-usual control condition (n=27). Both motivational interviewing and personalized feedback were delivered by undergraduate peer counsellors trained in Brief Alcohol Screening and Intervention for College Students (BASICS). Participants were assessed during their pledge year of university with a one-month follow-up. Primary outcomes for testing efficacy were alcohol use (quantity, heavy-drinking episodes, and peak blood alcohol concentration), and alcohol-related consequences. Quantitative data were analyzed using the U-Mann-Whitney and Wilcoxon test. Content analysis was used for measuring the feasibility of the program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peer Group, Motivational Interviewing, Cognitive Behavioral Therapy, Alcohol Drinking in College
Keywords
Brief interventions, Motivational interviewing, Peer counsellors, College students, Alcohol, Counsellor behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group: peer-led BASICS session
Arm Type
Experimental
Arm Description
Participants randomized to the intervention group received a peer-led BASICS session.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants randomized to the control group did not receive any specific intervention.
Intervention Type
Behavioral
Intervention Name(s)
Peer-led BASICS
Intervention Description
The peer-led BASICS session consisted in a face-to-face 50-minute motivational interview. In this meeting, the peer counsellor oriented the participant using a personalized graphic feedback sheet, with topics including participant's drinking pattern; level of intoxication; perceived and actual descriptive drinking norms, alcohol expectancies; drinking consequences; individual risk factors; financial costs; alcohol caloric consumption, and hours of exercise required to burn those calories, and protective behavioral strategies. Participants received a copy of the personalized feedback, a personalized BAC card, and a tips sheet. BASICS facilitators were volunteer undergraduate nursing students from who attented a pre-training course and showed being competent to conduct BASICS-based motivational interview and knowledgeable about alcohol.
Primary Outcome Measure Information:
Title
Change in 'Quantitaty of alcohol use in a typical weekend' (preliminary efficacy outcomes)
Description
Assesing the change in the total number of drinks during a typical weekend (Thursday, Friday, Saturday and Sunday) during the previous 30 days.
Time Frame
For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
Title
Change in 'Estimated peak blood alcohol content (peak BAC)' (preliminary efficacy outcomes)
Description
Assesing the change in the estimated peak blood alcohol content. It was calculated using participants' responses about maximum drinks consumed on the occasion of highest consumption in the last month, and the number of hours they spent drinking on that occasion.
Time Frame
For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
Title
Change in 'Frequency of binge drinking episodes' (preliminary efficacy outcomes)
Description
Assesing the change in the frequency of binge drinking episodes in the past month (5 or more (male)/ 4 or more (female) glasses of alcoholic beverages on the same drinking occasion).
Time Frame
For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
Title
Change in 'Number of alcohol-related consequences (preliminary efficacy outcomes)'
Description
Assesing the change in the number of negative consequences associated with their alcohol consumption in the previous 30 days.
Time Frame
For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
Secondary Outcome Measure Information:
Title
Peer counselors' fidelity -adherence to motivational interviewing skills and alcohol-related content (feasibility outcomes)
Description
Peer counselors' fidelity to the implementation of the intervention, including adherence to the theoretical alchol-related content, and the use of MI skills during the intervention. For their measurement, an alcohol-related content checklist and the Peer Proficiency Assessment were used.
Time Frame
From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.
Title
Barriers and facilitators of the implementation process (feasibility outcomes)
Description
Factors that have affected positively and negatively during the program implementation.
Time Frame
From the beginning of the peer counsellors' training until the end of the intervention, an average of 9 months.
Title
Acceptability -satisfaction- (feasibility outcomes)
Description
Satisfaction of both participants and peer counsellors with the program. It was used and ad-hoc questionnaire
Time Frame
From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: First year university students of Nursing Degree, between 18 and 20 years old. Students of first access to the University. Having had at least one episode of heavy drinking or binge drinking in the past month. Exclusion Criteria: Students who have started or previously studied other university degrees or a higher degree. University students who do not consume alcohol or, if they do consume alcohol, have not had binge drinking in the last month.
Facility Information:
Facility Name
University of Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Peer-led Brief Alcohol Intervention for College Student Drinkers in Spain

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