Peer GroupNCT05437484
Peer-led Brief Alcohol Intervention for College Student Drinkers in Spain
A study testing Peer-led BASICS in people with Peer Group and Motivational Interviewing, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Peer Group, Motivational Interviewing, Cognitive Behavioral Therapy
- What is being tested?
- Peer-led BASICS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2019to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 20 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design, Implementation and Evaluation of a Peer-led Alcohol Prevention Intervention for College Students. A Exploratory Trial
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.
Read the 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.
- Conditions
- Peer Group, Motivational Interviewing, Cognitive Behavioral Therapy, Alcohol Drinking in College
- Being tested
- Peer-led BASICS
- Keywords
- Brief interventions, Motivational interviewing, Peer counsellors, College students, Alcohol, Counsellor behavior
- Medical subject headings
- Alcohol Drinking in College
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-led BASICSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: peer-led BASICS session | Experimental | Participants randomized to the intervention group received a peer-led BASICS session. Receives: Behavioral: Peer-led BASICS |
| Control group | No intervention | Participants randomized to the control group did not receive any specific intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
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.
Measured: 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)
Factors that have affected positively and negatively during the program implementation.
Measured: From the beginning of the peer counsellors' training until the end of the intervention, an average of 9 months.
Acceptability -satisfaction- (feasibility outcomes)
Satisfaction of both participants and peer counsellors with the program. It was used and ad-hoc questionnaire
Measured: From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start2 Sep 2019
- Primary completion30 Apr 2020
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peer GroupStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Pueyo, Clinica Universidad de Navarra, Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437484
- Sponsor's protocol ID
- SP EXPLORATORIO
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design, Implementation and Evaluation of a Peer-led Alcohol Prevention Intervention for College Students. A Exploratory Trial
- ClinicalTrials.gov ID
- NCT05437484
- Acronym / sponsor ID
- SP EXPLORATORIO
- Conditions
- Peer Group, Motivational Interviewing, Cognitive Behavioral Therapy, Alcohol Drinking in College
- Keywords
- Brief interventions, Motivational interviewing, Peer counsellors, College students, Alcohol, Counsellor behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: peer-led BASICS session | Experimental | Behavioral: Peer-led BASICSParticipants randomized to the intervention group received a peer-led BASICS session. |
| Control group | No intervention | –Participants randomized to the control group did not receive any specific intervention. |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-led BASICSThe 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. | Behavioural | Intervention group: peer-led BASICS session |
Primary outcome
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.
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 '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.
3 secondary outcomes
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.
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.
Acceptability -satisfaction- (feasibility outcomes)
Time frame: From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-led BASICS in people with Peer Group and Motivational Interviewing, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.