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Study protocol: Mixed-methods evaluation of a cluster-randomized trial on preventing dysregulated screen use in
Juliane Schemmer1,2, Hanno Krafft1, Tobias Maurer1
1Institute 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.
Insights
This study evaluates an app-based intervention to reduce early childhood screen time. It uses the RE-AIM and CFIR frameworks to assess implementation effectiveness in pediatric practices.
Area of Science:
- Pediatric Health
- Digital Health Interventions
- Implementation Science
Background:
- Early childhood screen media use is linked to health and developmental issues.
- A preventive intervention aims to mitigate dysregulated screen time in children under three.
- This protocol details a process evaluation for effective implementation of this complex intervention.
Purpose of the Study:
- To understand the most effective implementation strategies for a complex intervention targeting early childhood screen time.
- To identify contextual factors influencing the intervention's effectiveness.
- To evaluate the implementation process using established frameworks.
Main Methods:
- Nation-wide cluster-randomized controlled trial involving pediatric practices.
- Intervention group received materials in May 2022; control group maintained usual care.
- Utilizes an app for collecting screen time and developmental data via parent surveys.
- Employs RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) and CFIR frameworks.
- Combines quantitative and qualitative data collection, including interviews with pediatricians and parents.
- Data collected at baseline, during the intervention, and after two years.
Main Results:
- Process evaluation data collection is ongoing.
- Analysis will focus on implementation fidelity, reach, adoption, maintenance, and contextual factors.
- Quantitative and qualitative findings will be integrated to provide a comprehensive understanding.
Conclusions:
- This protocol outlines a process evaluation for an app-based intervention in pediatric settings.
- The integration of RE-AIM and CFIR frameworks provides a robust approach to evaluating complex intervention implementation.
- Findings will inform future strategies for implementing digital health interventions in early childhood care.
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.
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