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Clinical Trials/NCT05437484
NCT05437484
Completed
Not Applicable

Design, Implementation and Evaluation of a Peer-led Alcohol Prevention Intervention for College Students. A Exploratory Trial

Clinica Universidad de Navarra, Universidad de Navarra1 site in 1 country50 target enrollmentSeptember 2, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peer Group
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Enrollment
50
Locations
1
Primary Endpoint
Change in 'Number of alcohol-related consequences (preliminary efficacy outcomes)'
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2, 2019
End Date
May 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Responsible Party
Principal Investigator
Principal Investigator

Sara Pueyo

Clinical nurse

Clinica Universidad de Navarra, Universidad de Navarra

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.

Outcomes

Primary Outcomes

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)

Assesing the change in the number of negative consequences associated with their alcohol consumption in the previous 30 days.

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)

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)

Time Frame: For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)

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 '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)

Assesing the change in the total number of drinks during a typical weekend (Thursday, Friday, Saturday and Sunday) during the previous 30 days.

Secondary Outcomes

  • Barriers and facilitators of the implementation process (feasibility outcomes)(From the beginning of the peer counsellors' training until the end of the intervention, an average of 9 months.)
  • Peer counselors' fidelity -adherence to motivational interviewing skills and alcohol-related content (feasibility outcomes)(From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.)
  • Acceptability -satisfaction- (feasibility outcomes)(From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.)

Study Sites (1)

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