- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05437484
Peer-led Brief Alcohol Intervention for College Student Drinkers in Spain
Design, Implementation and Evaluation of a Peer-led Alcohol Prevention Intervention for College Students. A Exploratory Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Navarra
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Pamplona, Navarra, Spain, 31008
- University of Navarra
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group: peer-led BASICS session
Participants randomized to the intervention group received a peer-led BASICS session.
|
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. |
No Intervention: Control group
Participants randomized to the control group did not receive any specific intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 'Quantitaty of alcohol use in a typical weekend' (preliminary efficacy outcomes)
Time Frame: For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
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Assesing the change in the total number of drinks during a typical weekend (Thursday, Friday, Saturday and Sunday) during the previous 30 days.
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For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
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Change in 'Estimated peak blood alcohol content (peak BAC)' (preliminary efficacy outcomes)
Time Frame: For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
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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.
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For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
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Change in 'Frequency of binge drinking episodes' (preliminary efficacy outcomes)
Time Frame: For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
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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).
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For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
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Change in 'Number of alcohol-related consequences (preliminary efficacy outcomes)'
Time Frame: For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
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Assesing the change in the number of negative consequences associated with their alcohol consumption in the previous 30 days.
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For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peer counselors' fidelity -adherence to motivational interviewing skills and alcohol-related content (feasibility outcomes)
Time Frame: From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.
|
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. |
From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.
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Barriers and facilitators of the implementation process (feasibility outcomes)
Time Frame: From the beginning of the peer counsellors' training until the end of the intervention, an average of 9 months.
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Factors that have affected positively and negatively during the program implementation.
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From the beginning of the peer counsellors' training until the end of the intervention, an average of 9 months.
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Acceptability -satisfaction- (feasibility outcomes)
Time Frame: From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.
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Satisfaction of both participants and peer counsellors with the program.
It was used and ad-hoc questionnaire
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From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP EXPLORATORIO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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