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

NCT07193030 | Not Yet Recruiting

• 1 other identifier: PP202207-30
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Receive brief counselling for 15-20 minutes by their peers who were trained.
2. 2.Report their alcohol consumption levels in three surveys conducted over three months.

Conditions

Binge Alcohol Consumption; Binge Drinking

Keywords

Binge drinking; Alcohol Brief Intervention; Behaviour change wheel; University students; Romania

Outcome Measures

Primary Outcomes (7)

• Recruitment rate

  Number of participants recruited

  Baseline, 3 month

• Retention rate

  Number of participants retained

  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.

  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.

  Baseline, 3 month

• Subjective norms

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

  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.

  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)

  end line (month 3)

Secondary Outcomes (1)

• Change in frequency of binge drinking in the past four weeks

  Baseline, 1 month, 3month

Study Arms (2)

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.

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

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.

Peer led- alcohol brief intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• Horizon 2020 - European Commission: collaborator

Related Publications (3)

• DeBerardinis RJ, Kazazian HH Jr. Analysis of the promoter from an expanding mouse retrotransposon subfamily. Genomics. 1999 Mar 15;56(3):317-23. doi: 10.1006/geno.1998.5729.

  PMID: 10087199 BACKGROUND

• 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.

  PMID: 20070207 BACKGROUND

• Mirowski M, Atlas P. [Importance of the precordial derivations for the diagnosis of auricular rhythms]. Arch Mal Coeur Vaiss. 1970 Feb;63(2):190-8. No abstract available. French.

  PMID: 4985973 BACKGROUND

MeSH Terms

Conditions

Binge Drinking

Interventions

Ethanol; Crisis Intervention; Counseling

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol Drinking; Drinking Behavior; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Psychotherapy; Behavioral Disciplines and Activities; Mental Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rubana Islam, PhD

  IARC

  PRINCIPAL INVESTIGATOR

• Carolina Espina, PhD

  IARC

  STUDY DIRECTOR

Central Study Contacts

Adriana Melnic, MD

CONTACT

+40264 594252; email:adriana.melnic@insp.gov.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: Parallel group cluster randomised trial

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 25, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share