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基于网络的筛查及简短干预措施结合每周短信发起的个性化提示对减少青少年危险饮酒行为的有效性:ProHEAD联盟内一项随机对照试验的研究方案

Effectiveness of a web-based screening and brief intervention with weekly text-message-initiated individualised prompts for reducing risky alcohol use among teenagers: study protocol of a randomised controlled trial within the ProHEAD consortium.

作者信息

Diestelkamp Silke, Wartberg Lutz, Kaess Michael, Bauer Stephanie, Rummel-Kluge Christine, Becker Katja, Eschenbeck Heike, Salize Hans-Joachim, Moessner Markus, Baldus Christiane, Arnaud Nicolas, Thomasius Rainer

机构信息

University Hospital Hamburg-Eppendorf, German Center for Addiction Research in Childhood and Adolescence, Martinistr. 52, W29, 20246, Hamburg, Germany.

Clinic of Child and Adolescent Psychiatry, Centre of Psychosocial Medicine, Heidelberg University Hospital, Blumenstraße 8, 69115, Heidelberg, Germany.

出版信息

Trials. 2019 Jan 22;20(1):73. doi: 10.1186/s13063-018-3160-z.

Abstract

BACKGROUND

Early and excessive alcohol use is a significant threat to healthy development. Evidence supports the effectiveness of electronic alcohol interventions for young drinkers. However, effects are typically small and studies targeting under 18-year-olds are scarce. This trial is the first to evaluate the effectiveness of a single-session, brief, motivational, web-based intervention (ProWISE) plus weekly text-message-initiated individualised prompts (TIPs) in reducing alcohol consumption and alcohol-related harm among children and adolescents aged ≥ 12 years. TIPs are designed to decrease risky alcohol use by reaching youth in the contexts of their everyday lives and by providing individualised feedback on drinking intentions, actual drinking and succession in achieving personal goals for low-risk drinking or abstinence.

METHODS/DESIGN: The trial is part of the multicentre consortium ProHEAD testing e-interventions for mental health problems in children and adolescents. Participants in grades 6-13 aged ≥ 12 years will be recruited in schools which participate in ProHEAD (target N = 15,000). Main criterion for inclusion in the ProWISE-TIP trial is a positive screening for at-risk alcohol use in the CRAFFT-d questionnaire (target n = 1076). In a multicentre, four-arm, randomised controlled design the following groups will be compared: (A) web-based intervention plus TIPs for 12 weeks; (B) web-based intervention plus text-message-initiated assessment of alcohol consumption for 12 weeks; (C) web-based intervention only; and (D) alcohol-related psychoeducation. TIPs will be delivered shortly before and after high-risk situations for excessive alcohol use and will be tailored to age, gender, drinking motives and alcohol consumption. Study participants will be followed up at three, six and nine months in the ProWISE-TIP trial and at one and two years in the ProHEAD consortium. Primary outcome is alcohol use in the past 30 days at nine months after enrolment. Secondary outcomes are alcohol-related problems, co-occurring substance use, health service utilisation, mental health problems and quality of life.

DISCUSSION

Trial results will generate important evidence on how to enhance effectiveness of single-session, web-based alcohol interventions for youth. The ProWISE-TIP intervention, if effective, can be used as a stand-alone alcohol intervention or as an add-on to school-based or community-based alcohol prevention programs.

TRIAL REGISTRATION

German Clinical Trials Register, DRKS00014606 Registered on 20 April 2018.

摘要

背景

过早且过度饮酒对健康发展构成重大威胁。有证据支持电子酒精干预对年轻饮酒者的有效性。然而,其效果通常较小,且针对18岁以下人群的研究稀缺。本试验首次评估单次、简短、具有激励性的基于网络的干预措施(ProWISE)加上每周通过短信发起的个性化提示(TIPs),在减少12岁及以上儿童和青少年酒精消费及与酒精相关危害方面的有效性。TIPs旨在通过在青少年日常生活场景中接触他们,并就饮酒意图、实际饮酒情况以及实现低风险饮酒或戒酒个人目标的进展提供个性化反馈,来减少危险饮酒行为。

方法/设计:该试验是多中心联盟ProHEAD测试针对儿童和青少年心理健康问题的电子干预措施的一部分。将在参与ProHEAD的学校招募6至13年级、年龄≥12岁的参与者(目标人数N = 15,000)。纳入ProWISE-TIP试验的主要标准是在CRAFFT-d问卷中对危险饮酒的筛查呈阳性(目标人数n = 1076)。在多中心、四臂随机对照设计中,将比较以下几组:(A)基于网络的干预措施加12周的TIPs;(B)基于网络的干预措施加12周通过短信发起的酒精消费评估;(C)仅基于网络的干预措施;以及(D)与酒精相关的心理教育。TIPs将在过度饮酒的高风险情况前后不久提供,并将根据年龄、性别、饮酒动机和酒精消费情况进行调整。在ProWISE-TIP试验中,将在3个月、6个月和9个月时对研究参与者进行随访,在ProHEAD联盟中则在1年和2年时进行随访。主要结局是入组9个月后过去30天内的饮酒情况。次要结局包括与酒精相关的问题、同时发生的物质使用、医疗服务利用、心理健康问题和生活质量。

讨论

试验结果将为如何提高针对青少年的单次基于网络的酒精干预措施的有效性提供重要证据。ProWISE-TIP干预措施若有效,可作为独立的酒精干预措施,或作为学校或社区酒精预防项目的补充。

试验注册

德国临床试验注册中心,DRKS00014606,于2018年4月20日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9ac/6341631/4812f4b46a82/13063_2018_3160_Fig1_HTML.jpg

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