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NCT Number: NCT07193030

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

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.

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Key information

Conditions

Binge Alcohol Consumption Alcohol Drinking Alcohol-Related Disorders Behavior Binge Drinking Chemically-Induced Disorders Drinking Behavior Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.

Treatment and study plan

Peer-led Alcohol Brief Intervention (identification + advice)

Behavioral

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.

Primary outcomes

  1. Recruitment rate

    Time frame: Baseline, 3 month

    Number of participants recruited

  2. Retention rate

    Time frame: Baseline, 3 month

    Number of participants retained

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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)

Secondary outcomes

  1. Change in frequency of binge drinking in the past four weeks

    Time frame: Baseline, 1 month, 3month

    measured via self-report using AUDIT-C, e.g. number of binge episodes, ≥6 drinks or 60 g of pure alcohol on one occasion

Study contacts

Contact information is provided by the study sponsor or research team.

Adriana Melnic, MD

CONTACT

email:[email protected]

+40264 594252 ext. 113

Sponsors and collaborators

Lead sponsor

International Agency for Research on Cancer

Other

Collaborators

  • Horizon 2020 - European Commission

Registry information

Official study title

Peer-Led Intervention To Reduce Alcohol Binge Drinking Among University Students In Romania- A Pilot Study Of The Implementation Processes

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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