ArticlePloS one2025
Study protocol: Mixed-methods evaluation of a cluster-randomized trial on preventing dysregulated screen use in children under 3.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- "I Haven't Had Anyone Talk to Me About Phone Use, At All": Primiparous Mothers' Conversations About Smartphone Use While Caregiving.International journal of environmental research and public health · 2025Article
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundScreen 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.
methodsThe 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.
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