研究方案：一项关于预防3岁以下儿童屏幕使用失调的整群随机试验的混合方法评估
Study protocol: Mixed-methods evaluation of a cluster-randomized trial on preventing dysregulated screen use in children under 3.
作者信息
Schemmer Juliane, Krafft Hanno, Maurer Tobias, Lange Silke, Emgenbroich Anke, Monks Sean, Martin David, Schwarz Silke
机构信息
Institute for Integrative Medicine, Chair of Medical Theory, Integrative and Anthroposophic Medicine, Department of Human Medicine, Faculty of Health/School of Medicine, Witten/Herdecke University, Herdecke, Germany.
Interprofessional Graduate School Integrative Medicine and Health, Health Department, University of Witten/Herdecke, Witten, Germany.
出版信息
PLoS One. 2025 May 19;20(5):e0324012. doi: 10.1371/journal.pone.0324012. eCollection 2025.
BACKGROUND
Screen media use in early childhood is associated with increased risk for health and developmental problems. A preventive intervention during a regular examination in pediatric practices aims to prevent dysregulated screen time by children under three years of age. This protocol describes a process evaluation with the aim of understanding how to implement most effectively a complex intervention to prevent dysregulated screen time in childhood. For this purpose, the process evaluation combines two frameworks to identify both the implementation process and the relevant contextual factors.
METHODS
The focus of this process evaluation is a nation-wide, cluster-randomized controlled trial with a complex intervention. Two-thirds of all pediatric practices registered with Professional Association of Pediatricians in Germany received the intervention materials with the option to participate in May 2022, while one-third maintain as usual. Since than an app has been collecting children's screen time and developmental diagnostic parameters using a longitudinal parent survey. The process evaluation will examine the implementation process following the RE-AIM scheme (Reach, Effectiveness, Adoption, Implementation, and Maintenance) as well as the relevant contextual factors influencing the effectiveness of the implementation process following the Consolidated Framework for Implementation Research. Data collection will include quantitative and qualitative methods. Measurement points are at the start of the intervention, several times during the ongoing intervention and after two years. The two groups of people will be interviewed: Pediatricians who use the intervention in their practice and parents who have received the intervention.
DISCUSSION
This protocol illustrates the process evaluation of a complex, app-based intervention in pediatric practices. It combines the two frameworks RE-AIM and CFIR and thus covers all aspects of the evaluation of the implementation process of a complex intervention.
TRIAL REGISTER NUMBER
DRKS00032258; https://drks.de/search/en/trial/DRKS00032258.
背景
幼儿期使用屏幕媒体与健康和发育问题风险增加有关。在儿科诊所的定期检查期间进行预防性干预，旨在防止三岁以下儿童的屏幕时间失调。本方案描述了一项过程评估，目的是了解如何最有效地实施一项复杂干预措施，以防止儿童屏幕时间失调。为此，过程评估结合了两个框架，以确定实施过程和相关背景因素。
方法
该过程评估的重点是一项全国性的、集群随机对照试验，采用复杂干预措施。在德国儿科医生专业协会注册的所有儿科诊所中，三分之二在2022年5月收到了干预材料并有机会参与，而三分之一则照常进行。从那时起，一款应用程序通过纵向家长调查收集儿童的屏幕时间和发育诊断参数。过程评估将按照RE-AIM方案（覆盖范围、有效性、采用率、实施情况和维持情况）检查实施过程，以及按照实施研究综合框架检查影响实施过程有效性的相关背景因素。数据收集将包括定量和定性方法。测量点在干预开始时、干预进行期间的几次以及两年后。将对两组人员进行访谈：在其诊所使用该干预措施的儿科医生和接受该干预措施的家长。
讨论
本方案说明了在儿科诊所对一项基于应用程序的复杂干预措施进行的过程评估。它结合了RE-AIM和CFIR这两个框架，从而涵盖了对复杂干预措施实施过程评估的所有方面。
试验注册号
DRKS00032258；https://drks.de/search/en/trial/DRKS00032258 。
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