Study protocol: Mixed-methods evaluation of a cluster-randomized trial on preventing dysregulated screen use in...

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.