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Набор скоро начнётся NCT07193030

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

Без фазы С лечением Binge Alcohol Consumption Binge Drinking

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Peer-led Alcohol Brief Intervention (identification + advice).
Кому может быть актуально
Состояния в реестре: Binge Alcohol Consumption, Binge Drinking. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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 ta

Первичные конечные точки

  • Recruitment rate [Срок оценки: Baseline, 3 month]
  • Retention rate [Срок оценки: Baseline, 3 month]
  • Knowledge on binge drinking and adverse outcomes [Срок оценки: Baseline, 1 month, 3 month]
  • Attitude [Срок оценки: Baseline, 3 month]
  • Subjective norms [Срок оценки: Baseline, 3 month]
  • Intention to change [Срок оценки: Baseline, 3 month]
  • Feasibility outcome [Срок оценки: end line (month 3)]
Вторичные конечные точки (1)
  • Change in frequency of binge drinking in the past four weeks [Срок оценки: Baseline, 1 month, 3month]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 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. PMID 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. PMID 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. PMID 27515753

Идентификаторы

NCT: NCT07193030 · PP202207-30

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗