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临床试验/NCT05437484
NCT05437484已完成不适用

Design, Implementation and Evaluation of a Peer-led Alcohol Prevention Intervention for College Students. A Exploratory Trial

Clinica Universidad de Navarra, Universidad de Navarra2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年9月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Change in 'Number of alcohol-related consequences (preliminary efficacy outcomes)'

研究概览

简要总结

A pilot randomized controlled trial was carried out. Fifty nursing students were randomly assigned either a 50-minute brief motivational intervention with individual feedback or a treatment-as-usual control condition. The intervention was delivered by undergraduate peer counsellors trained in Brief Alcohol Screening and Intervention for College Students. Primary outcomes for testing efficacy were alcohol use and alcohol-related consequences.

详细描述

Aims: To assess the potential efficacy and the feasibility of a peer-led brief alcohol intervention aimed to reduce the alcohol consumption in Spanish heavy nursing student drinkers.

Methods: A pilot randomized controlled trial was carried out. Fifty nursing students were randomly assigned either a 50-minute brief motivational enhancement intervention with individual feedback (n=23) or a treatment-as-usual control condition (n=27). Both motivational interviewing and personalized feedback were delivered by undergraduate peer counsellors trained in Brief Alcohol Screening and Intervention for College Students (BASICS). Participants were assessed during their pledge year of university with a one-month follow-up. Primary outcomes for testing efficacy were alcohol use (quantity, heavy-drinking episodes, and peak blood alcohol concentration), and alcohol-related consequences. Quantitative data were analyzed using the U-Mann-Whitney and Wilcoxon test. Content analysis was used for measuring the feasibility of the program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 20 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • First year university students of Nursing Degree, between 18 and 20 years old.
  • Students of first access to the University.
  • Having had at least one episode of heavy drinking or binge drinking in the past month.

排除标准

  • Students who have started or previously studied other university degrees or a higher degree.
  • University students who do not consume alcohol or, if they do consume alcohol, have not had binge drinking in the last month.

结局指标

主要结局

Change in 'Number of alcohol-related consequences (preliminary efficacy outcomes)'

时间窗: For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)

Assesing the change in the number of negative consequences associated with their alcohol consumption in the previous 30 days.

Change in 'Estimated peak blood alcohol content (peak BAC)' (preliminary efficacy outcomes)

时间窗: For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)

Assesing the change in the estimated peak blood alcohol content. It was calculated using participants' responses about maximum drinks consumed on the occasion of highest consumption in the last month, and the number of hours they spent drinking on that occasion.

Change in 'Frequency of binge drinking episodes' (preliminary efficacy outcomes)

时间窗: For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)

Assesing the change in the frequency of binge drinking episodes in the past month (5 or more (male)/ 4 or more (female) glasses of alcoholic beverages on the same drinking occasion).

Change in 'Quantitaty of alcohol use in a typical weekend' (preliminary efficacy outcomes)

时间窗: For measuring the change, there are two time points: pre-test and post-test (one month after receiving the programme)

Assesing the change in the total number of drinks during a typical weekend (Thursday, Friday, Saturday and Sunday) during the previous 30 days.

次要结局

  • Barriers and facilitators of the implementation process (feasibility outcomes)(From the beginning of the peer counsellors' training until the end of the intervention, an average of 9 months.)
  • Peer counselors' fidelity -adherence to motivational interviewing skills and alcohol-related content (feasibility outcomes)(From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.)
  • Acceptability -satisfaction- (feasibility outcomes)(From the beginning of the intervention sessions until the end of the intervention, an average of 3 months.)

研究者

发起方
Clinica Universidad de Navarra, Universidad de Navarra
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Pueyo

Clinical nurse

Clinica Universidad de Navarra, Universidad de Navarra

研究点 (2)

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