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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05437484
Other study ID # SP EXPLORATORIO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2019
Est. completion date May 31, 2021

Study information

Verified date June 2022
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 31, 2021
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 20 Years
Eligibility 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 Design


Intervention

Behavioral:
Peer-led BASICS
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.

Locations

Country Name City State
Spain University of Navarra Pamplona Navarra

Sponsors (1)

Lead Sponsor Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
Primary 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. For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
Primary 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). For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
Primary 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. For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)
Secondary 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.
From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.
Secondary Barriers and facilitators of the implementation process (feasibility outcomes) Factors that have affected positively and negatively during the program implementation. From the beginning of the peer counsellors' training until the end of the intervention, an average of 9 months.
Secondary Acceptability -satisfaction- (feasibility outcomes) Satisfaction of both participants and peer counsellors with the program. It was used and ad-hoc questionnaire From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.
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