Screen-Free Time with Friends: Study Protocol for a Cluster-Randomized Controlled Trial to Promote Face-to-Face Interaction with Peers and Reduce Recreational Screen Use among Children Aged 9–11 Years (Preprint)

<sec> <title>BACKGROUND</title> Children’s leisure time has changed in recent decades, with more time spent on screen media and less time face-to-face with peers - potentially affecting their physical and mental well-being. </sec> <sec> <title>OBJECTIVE</title> This protocol outlines the design of a study investigating the effectiveness of the Screen-Free Time with Friends intervention aimed to promote more time face-to-face with peers and reduce recreational screen media use among children aged 9-11 years. </sec> <sec> <title>METHODS</title> The study is conducted as a cluster-randomized controlled trial involving children aged 9–11-year-old and their parents from 18 schools in Denmark. Schools are randomized (1:1) to either a control or an intervention group. The intervention includes five core components: (1) curricular activities, (2) two family meetings, (3) a brief parent exercise, (4) a development program for after-school clubs, and (5) two community workshops. It is designed to allow local adaptation while maintaining fidelity to the core components. The primary outcome—children’s time spent face-to-face with peers during leisure - is assessed at T0 (baseline), T0+[6–10 months], and T0+[13-15 months] (follow-up). Secondary outcomes including screen media use, physical activity, social relations, and well-being are measured at baseline and follow-up. A comprehensive process evaluation explores implementation, context, and mechanisms of change. </sec> <sec> <title>RESULTS</title> The project was funded in July 2020. Schools were recruited from July 2023 to January 2024, while children and parents were recruited from November 2023 to April 2024. At baseline, 685 children were enrolled at the participating schools, with 343 (50%) having at least one parent enrolled in the questionnaire. Baseline data were collected from December 2023 to June 2024, and follow-up data from March to August 2025. As of September 2025, data analysis has not yet commenced, and no study results are currently available. Findings are expected to be published by the end of 2025. </sec> <sec> <title>CONCLUSIONS</title> This paper presents the protocol for a cluster-randomized controlled trial evaluating the Screen-Free Time with Friends intervention, designed to increase face-to-face interaction and reduce recreational screen use among children aged 9-11 years. Regardless of the findings, this study will generate important knowledge about the intervention’s potential effectiveness, com-plemented by insights into how, why, and under what circumstances it may lead to meaningful changes. These insights can assist municipalities, schools, after-school clubs, community stake-holders, and parents in shaping everyday environments that foster children’s face-to-face interac-tion and encourage balanced screen use. Furthermore, the findings may inform policy decisions, guide the development of new initiatives, and inspire future research into practical, real-world interventions that support meaningful and enriching leisure experiences for children. </sec> <sec> <title>CLINICALTRIAL</title> ClinicalTrials.gov, ID: NCT06163495, Registered 17/11/2023. </sec>