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| Name | Class |
|---|---|
| Horizon 2020 - European Commission | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| No intervention | No Intervention | The control arm will receive no intervention. They will only complete the surveys at three time points. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 1 month, 3month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adriana Melnic, MD | Contact | +40264 594252 | 113 | email:adriana.melnic@insp.gov.ro |
| Name | Affiliation | Role |
|---|---|---|
| Rubana Islam, PhD | IARC | Principal Investigator |
| Carolina Espina, PhD | IARC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36057959 | Background | 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. | |
| 20070207 |
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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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| ID | Term |
|---|---|
| D063425 | Binge Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000428 | Alcohol Drinking |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D003419 | Crisis Intervention |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Parallel group cluster randomised trial
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| end line (month 3) |
| 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. |
| 27515753 | Background | 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. |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D008605 |
| Mental Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |