Binge Alcohol ConsumptionNCT07193030
Peer-Led Intervention To Reduce Alcohol Binge Drinking Among University Students In Romania
A study testing Peer-led Alcohol Brief Intervention (identification + advice) in people with Binge Alcohol Consumption and Binge Drinking, run by International Agency for Research on Cancer.
Trial summary
The goal of this clinical trial is to learn if a behavioural intervention to change binge drinking habits in university students in Romania is feasible. The main research question is: Is a peer-led Alcohol Brief Intervention feasible to be implemented in a Romanian University to reduce binge drinking among students?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge Alcohol Consumption, Binge Drinking
- What is being tested?
- Peer-led Alcohol Brief Intervention (identification + advice)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- University students currently enrolled in full-time undergraduate or postgraduate programs at Babeș-Bolyai University in Romania
- Able to provide informed consent
- Willing to participate in an in-person session
- Alcohol status: AUDIT-C scoring 3 or above in females, 4 or above in males
Who cannot join
- Students currently receiving treatment for alcohol dependence or any other substance use disorder
- Students with a diagnosed severe mental health condition that may impair participation
- Participation in any similar alcohol reduction program in the past 6 months.
- Abstinent from alcohol consumption.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Peer-Led Intervention To Reduce Alcohol Binge Drinking Among University Students In Romania- A Pilot Study Of The Implementation Processes
The goal of this clinical trial is to learn if a behavioural intervention to change binge drinking habits in university students in Romania is feasible. The main research question is:
Is a peer-led Alcohol Brief Intervention feasible to be implemented in a Romanian University to reduce binge drinking among students?
Researchers will compare brief intervention (counselling) to no intervention.
Student participants will:
- Receive brief counselling for 15-20 minutes by their peers who were trained.
- Report their alcohol consumption levels in three surveys conducted over three months.
Read the detailed description
Pre-intervention focus group discussions: Students will be involved in group discussions, up to 90 minutes, to share their perspective on binge drinking.
Pre-intervention co-design workshop: Students will be involved in a 3-hour workshop to co-design messages to be used during the brief advice intervention.
University staff will be invited to participate in in-depth interviews lasting up to 60 minutes.
Intervention:
Student participants- They will be administered a pre-intervention survey lasting approximately 60-minutes by research assistants, a 15-20 minutes brief advice/counselling session by their peers, a midline survey of 5 minutes, and an endline survey of approximately 60 minutes administered by research assistants. these students will be invited to take part in a focus group at the end of the intervention lasting 90 minutes.
Peers- Peers are students who volunteered to deliver the brief counselling to other students. They will first undergo training by motivational interviewing experts for approximately 6-8 hours spread across 2 days. We intend to recruit 4 peers and each one will deliver the brief advice to 15 students, each session lasting 15-20 minutes. The peers will then be invited to participate in a focus group discussion lasting up to 90 minutes at the end of the intervention.
- Conditions
- Binge Alcohol Consumption, Binge Drinking
- Being tested
- Peer-led Alcohol Brief Intervention (identification + advice)
- Keywords
- Binge drinking, Alcohol Brief Intervention, Behaviour change wheel, University students, Romania
- Medical subject headings
- Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-led Alcohol Brief Intervention (identification + advice)Behavioural
The intervention consists of a peer-led ABI for university students. This intervention aligns with the ABI approach recommended by the WHO as a cost-effective strategy to reduce harmful alcohol use, particularly in primary care and community settings. The brief advice component of the intervention will incorporate Motivational Interviewing (MI) techniques, a client-centred, evidence-based counselling style intervention effective for reducing risky drinking behaviours. The brief advice will be tailored based on behavioural insights identified through formative research, such as individual perceived facilitators and barriers.
The Alcohol Use Disorders Identification Test- Consumption (AUDIT-C) will be used as the screening tool for identification.
A one-on-one Brief Advice sessions of 15-20 minutes will be delivered by trained peer educators, i.e., university students who are not healthcare professionals but have been specifically trained in delivering brief advice.
| Study group | Role | What they receive |
|---|---|---|
| Peer led- alcohol brief intervention | Experimental | The intervention arm will receive the brief advice from their peers about binge drinking. The intervention will last 15-20 minutes. Receives: Behavioral: Peer-led Alcohol Brief Intervention (identification + advice) |
| No intervention | No intervention | The control arm will receive no intervention. They will only complete the surveys at three time points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of participants recruited
Measured: Baseline, 3 month
Retention rate
Number of participants retained
Measured: Baseline, 3 month
Knowledge on binge drinking and adverse outcomes
Change in knowledge on binge drinking and adverse outcomes. Ad hoc questions developed for this study will be used. Scoring will be done on the number questions answered correctly.
Measured: Baseline, 1 month, 3 month
Attitude
Change in attitude to binge drinking using the Theory of Planned Behaviour tool (by Cooke, R., 2007). A 7-point Likert scale will be used on five bipolar scales (harmful-beneficial, unpleasant-pleasant, bad-good, worthless-valuable, unenjoyable-enjoyable.
Measured: Baseline, 3 month
Subjective norms
Change in subjective norms using the Theory of Planned Behaviour tool. A 7 point Likert scale will be used.
Measured: Baseline, 3 month
Intention to change
Change in intention change using the Theory of Planned Behaviour tool. A 7 point Likert scale will be used.
Measured: Baseline, 3 month
Feasibility outcome
This will be explored qualitatively asking questions about study acceptability, appropriateness, and fidelity using semi-structured interview guidelines. (Note: This is a qualitative outcome; no scoring will be done)
Measured: end line (month 3)
Secondary outcomes (1)
Change in frequency of binge drinking in the past four weeks
measured via self-report using AUDIT-C, e.g. number of binge episodes, ≥6 drinks or 60 g of pure alcohol on one occasion
Measured: Baseline, 1 month, 3month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Mar 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Binge Alcohol ConsumptionStudies 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
- Model description
- Parallel group cluster randomised trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon 2020 - European Commission
- Responsible party
- Principal investigator, Rubana Islam, International Agency for Research on Cancer
- Investigators
- Rubana Islam, PhD, Principal investigator, IARCCarolina Espina, PhD, Study director, IARC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193030
- Sponsor's protocol ID
- PP202207-30
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because of confidentiality concerns and the sensitive nature of the information collected. The trial was not designed with participant consent for public data sharing, and de-identification would not fully eliminate the risk of re-identification. Findings will instead be disseminated through aggregated results in publications and reports.
Publications
Lavilla-Gracia M, Pueyo-Garrigues M, Pueyo-Garrigues S, Pardavila-Belio MI, Canga-Armayor A, Esandi N, Alfaro-Diaz C, Canga-Armayor N. Peer-led interventions to reduce alcohol consumption in college students: A scoping review. Health Soc Care Community. 2022 Nov;30(6):e3562-e3578. doi: 10.1111/hsc.13990. Epub 2022 Sep 4.
PubMed 36057959Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health. 2010;31:399-418. doi: 10.1146/annurev.publhealth.012809.103604.
PubMed 20070207Platt L, Melendez-Torres GJ, O'Donnell A, Bradley J, Newbury-Birch D, Kaner E, Ashton C. How effective are brief interventions in reducing alcohol consumption: do the setting, practitioner group and content matter? Findings from a systematic review and metaregression analysis. BMJ Open. 2016 Aug 11;6(8):e011473. doi: 10.1136/bmjopen-2016-011473.
PubMed 27515753
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-Led Intervention To Reduce Alcohol Binge Drinking Among University Students In Romania- A Pilot Study Of The Implementation Processes
- ClinicalTrials.gov ID
- NCT07193030
- Acronym / sponsor ID
- PP202207-30
- Conditions
- Binge Alcohol Consumption, Binge Drinking
- Keywords
- Binge drinking, Alcohol Brief Intervention, Behaviour change wheel, University students, Romania
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- Horizon 2020 - European Commission
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 25 Sep 2025 (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.
The goal of this clinical trial is to learn if a behavioural intervention to change binge drinking habits in university students in Romania is feasible. The main research question is:
Is a peer-led Alcohol Brief Intervention feasible to be implemented in a Romanian University to reduce binge drinking among students?
Researchers will compare brief intervention (counselling) to no intervention.
Student participants will:
- Receive brief counselling for 15-20 minutes by their peers who were trained.
- Report their alcohol consumption levels in three surveys conducted over three months.
Detailed description
Pre-intervention focus group discussions: Students will be involved in group discussions, up to 90 minutes, to share their perspective on binge drinking.
Pre-intervention co-design workshop: Students will be involved in a 3-hour workshop to co-design messages to be used during the brief advice intervention.
University staff will be invited to participate in in-depth interviews lasting up to 60 minutes.
Intervention:
Student participants- They will be administered a pre-intervention survey lasting approximately 60-minutes by research assistants, a 15-20 minutes brief advice/counselling session by their peers, a midline survey of 5 minutes, and an endline survey of approximately 60 minutes administered by research assistants. these students will be invited to take part in a focus group at the end of the intervention lasting 90 minutes.
Peers- Peers are students who volunteered to deliver the brief counselling to other students. They will first undergo training by motivational interviewing experts for approximately 6-8 hours spread across 2 days. We intend to recruit 4 peers and each one will deliver the brief advice to 15 students, each session lasting 15-20 minutes. The peers will then be invited to participate in a focus group discussion lasting up to 90 minutes at the end of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group cluster randomised trial
| Arm | Type | Receives |
|---|---|---|
| Peer led- alcohol brief intervention | Experimental | Behavioral: Peer-led Alcohol Brief Intervention (identification + advice)The intervention arm will receive the brief advice from their peers about binge drinking. The intervention will last 15-20 minutes. |
| No intervention | No intervention | –The control arm will receive no intervention. They will only complete the surveys at three time points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- University students currently enrolled in full-time undergraduate or postgraduate programs at Babeș-Bolyai University in Romania
- Able to provide informed consent
- Willing to participate in an in-person session
- Alcohol status: AUDIT-C scoring 3 or above in females, 4 or above in males
Key exclusion criteria (4 listed)
- Students currently receiving treatment for alcohol dependence or any other substance use disorder
- Students with a diagnosed severe mental health condition that may impair participation
- Participation in any similar alcohol reduction program in the past 6 months.
- Abstinent from alcohol consumption.
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 Alcohol Brief Intervention (identification + advice)The intervention consists of a peer-led ABI for university students. This intervention aligns with the ABI approach recommended by the WHO as a cost-effective strategy to reduce harmful alcohol use, particularly in primary care and community settings. The brief advice component of the intervention will incorporate Motivational Interviewing (MI) techniques, a client-centred, evidence-based counselling style intervention effective for reducing risky drinking behaviours. The brief advice will be tailored based on behavioural insights identified through formative research, such as individual perceived facilitators and barriers. The Alcohol Use Disorders Identification Test- Consumption (AUDIT-C) will be used as the screening tool for identification. A one-on-one Brief Advice sessions of 15-20 minutes will be delivered by trained peer educators, i.e., university students who are not healthcare professionals but have been specifically trained in delivering brief advice. | Behavioural | Peer led- alcohol brief intervention |
Primary outcome
Recruitment rate
Time frame: Baseline, 3 month
Number of participants recruited
Retention rate
Time frame: Baseline, 3 month
Number of participants retained
Knowledge on binge drinking and adverse outcomes
Time frame: Baseline, 1 month, 3 month
Change in knowledge on binge drinking and adverse outcomes. Ad hoc questions developed for this study will be used. Scoring will be done on the number questions answered correctly.
Attitude
Time frame: Baseline, 3 month
Change in attitude to binge drinking using the Theory of Planned Behaviour tool (by Cooke, R., 2007). A 7-point Likert scale will be used on five bipolar scales (harmful-beneficial, unpleasant-pleasant, bad-good, worthless-valuable, unenjoyable-enjoyable.
Subjective norms
Time frame: Baseline, 3 month
Change in subjective norms using the Theory of Planned Behaviour tool. A 7 point Likert scale will be used.
Intention to change
Time frame: Baseline, 3 month
Change in intention change using the Theory of Planned Behaviour tool. A 7 point Likert scale will be used.
Feasibility outcome
Time frame: end line (month 3)
This will be explored qualitatively asking questions about study acceptability, appropriateness, and fidelity using semi-structured interview guidelines. (Note: This is a qualitative outcome; no scoring will be done)
1 secondary outcome
Change in frequency of binge drinking in the past four weeks
Time frame: Baseline, 1 month, 3month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 36057959Lavilla-Gracia M, Pueyo-Garrigues M, Pueyo-Garrigues S, Pardavila-Belio MI, Canga-Armayor A, Esandi N, Alfaro-Diaz C, Canga-Armayor N. Peer-led interventions to reduce alcohol consumption in college students: A scoping review. Health Soc Care Community. 2022 Nov;30(6):e3562-e3578. doi: 10.1111/hsc.13990. Epub 2022 Sep 4.
- Background: PubMed 20070207Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health. 2010;31:399-418. doi: 10.1146/annurev.publhealth.012809.103604.
- Background: PubMed 27515753Platt L, Melendez-Torres GJ, O'Donnell A, Bradley J, Newbury-Birch D, Kaner E, Ashton C. How effective are brief interventions in reducing alcohol consumption: do the setting, practitioner group and content matter? Findings from a systematic review and metaregression analysis. BMJ Open. 2016 Aug 11;6(8):e011473. doi: 10.1136/bmjopen-2016-011473.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because of confidentiality concerns and the sensitive nature of the information collected. The trial was not designed with participant consent for public data sharing, and de-identification would not fully eliminate the risk of re-identification. Findings will instead be disseminated through aggregated results in publications and reports.
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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.
Rubana Islam, PhD principal investigator
IARC
Carolina Espina, PhD study director
IARC
Questions about this trial
What is this clinical trial studying?
A study testing Peer-led Alcohol Brief Intervention (identification + advice) in people with Binge Alcohol Consumption and Binge Drinking, run by International Agency for Research on Cancer.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adriana Melnic, MD (+40264 594252 ext. 113, email:adriana.melnic@insp.gov.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline, 3 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07193030, which also lists 3 linked publications.
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 1 Oct 2025.