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Not yet recruitingNCT07193030Updated Oct 1, 2025

Peer-Led Intervention To Reduce Alcohol Binge Drinking Among University Students In Romania

An interventional study of Peer-led Alcohol Brief Intervention (identification + advice) in Binge Alcohol Consumption and Binge Drinking, sponsored by International Agency for Research on Cancer. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.

Sponsored by International Agency for Research on Cancer · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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?

Researchers will compare brief intervention (counselling) to no intervention.

Student participants will:

  1. Receive brief counselling for 15-20 minutes by their peers who were trained.
  2. 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.

02

Conditions studied

  • Binge Alcohol Consumption
  • Binge Drinking

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Keywords

  • Binge drinking
  • Alcohol Brief Intervention
  • Behaviour change wheel
  • University students
  • Romania
03

In context

Binge Drinking

71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.

This study's planned enrollment of 120 is close to the median of 120 across 64 interventional studies indexed under Binge Drinking.

Browse Binge Drinking studies →

Lead sponsor

International Agency for Research on Cancer is the lead sponsor of 30 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • University students currently enrolled in full-time undergraduate or postgraduate programs at Babeș-Bolyai University in Romania
  • Able to provide
  • Willing to participate in an in-person session
  • Alcohol status: AUDIT-C scoring 3 or above in females, 4 or above in males

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Peer led- alcohol brief intervention

    The intervention arm will receive the brief advice from their peers about binge drinking. The intervention will last 15-20 minutes.

    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.

Interventions

  • BehavioralPeer-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.

06

What researchers measure

Primary outcomes

  1. Recruitment rate

    Number of participants recruited

    Time frame: Baseline, 3 month

  2. Retention rate

    Number of participants retained

    Time frame: Baseline, 3 month

  3. 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.

    Time frame: Baseline, 1 month, 3 month

  4. 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.

    Time frame: Baseline, 3 month

  5. Subjective norms

    Change in subjective norms using the Theory of Planned Behaviour tool. A 7 point Likert scale will be used.

    Time frame: Baseline, 3 month

  6. Intention to change

    Change in intention change using the Theory of Planned Behaviour tool. A 7 point Likert scale will be used.

    Time frame: Baseline, 3 month

  7. 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)

    Time frame: 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

    Time frame: Baseline, 1 month, 3month

07

Study locations

No study locations are listed for this record.

08

References and documents

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 36057959 ↗
  • Glanz 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 20070207 ↗
  • Platt 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 ↗

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07193030
Lead sponsor
International Agency for Research on Cancer
Collaborators
Horizon 2020 - European Commission
Responsible party
Rubana Islam (Scientist, International Agency for Research on Cancer) — Principal investigator
First posted
Sep 25, 2025
Start date
Mar 1, 2026 (estimated)
Primary completion
Jul 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Oct 1, 2025

Study contacts

Adriana Melnic, MD
Contact
email:adriana.melnic@insp.gov.ro
+40264 594252 ext. 113
Rubana Islam, PhD
principal investigator · IARC
Carolina Espina, PhD
study director · IARC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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