Study protocol for the Screen-Free Time with Friends Feasibility Trial

Background: Children are spending less leisure time with their friends in person and an increasing amount of time with digital screens. These changes may negatively affect children’s physical and mental health. The Screen-Free Time with Friends Feasibility Trial will test the feasibility, including acceptability and compliance, of an intervention designed to reduce screen media usage and en-courage physical interaction with friends during leisure time in 9-11-year-old children.

Methods: A non-randomized single group feasibility trial will be conducted from March to Octo-ber 2023 including approximately 75 children (aged 9-11 years) and 75 parents (at least one per child) from three different schools recruited from three different municipalities in Denmark. The Screen-Free Time with Friends intervention is a multicomponent intervention targeting families, afterschool clubs and local communities. It has been developed using a systematic process guided by the Medical Research Council UK's framework for developing and evaluating complex interven-tions. With a systems perspective in mind, the intervention and implementation approach has been designed to facilitate adaptation to the specific needs of diverse local communities, while maintaining the core components of the intervention.

Feasibility and acceptability of the intervention will be assessed during the intervention using pro-cess evaluation inspired by the RE-AIM framework including questionnaires and interviews with the municipality project managers, research team members, local ambassadors and stakeholders, parents and school and afterschool club personnel. In addition, participation, recruitment, reten-tion rate and compliance to the outcome measurements will be investigated and presented.
Discussion: The trial will investigate the feasibility and acceptability of the Screen-Free Time with Friends intervention, the recruitment strategy and the planned outcome measurements. This fea-sibility study will investigate necessary refinements before the implementation of the intervention program in a larger cluster randomized controlled trial to evaluate its impact.