NCT05437484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 16, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

June 16, 2022

Last Update Submit

June 23, 2022

Conditions

Keywords

Brief interventionsMotivational interviewingPeer counsellorsCollege studentsAlcoholCounsellor behavior

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (3)

  • 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.

  • 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.

  • Acceptability -satisfaction- (feasibility outcomes)

    From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.

Study Arms (2)

Intervention group: peer-led BASICS session

EXPERIMENTAL

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

Behavioral: Peer-led BASICS

Control group

NO INTERVENTION

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

Interventions

Peer-led BASICSBEHAVIORAL

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.

Intervention group: peer-led BASICS session

Eligibility Criteria

Age18 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Alcohol Drinking in College

Condition Hierarchy (Ancestors)

Alcohol DrinkingDrinking BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical nurse

Study Record Dates

First Submitted

June 16, 2022

First Posted

June 29, 2022

Study Start

September 2, 2019

Primary Completion

April 30, 2020

Study Completion

May 31, 2021

Last Updated

June 29, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations