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Screen Free Time With Friends: a Cluster-randomized Controlled Trial

Screen Free Time With Friends: a Cluster-randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06163495
Enrollment
685
Registered
2023-12-11
Start date
2023-11-17
Completion date
2025-07-01
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Screen Media Use, Time Face to Face With Friends

Brief summary

The Screen Free Time with Friends study is a cluster-randomized controlled trial aiming to promote more time face-to-face with friends and reduce recreational screen media use after school and during weekends among children aged 9-11 years. The primary aim is to investigate the between group difference in change in children's time spend face-to-face with peers. Secondary aims are to investigate the between group difference in change in children's screen media use, physical activity, wellbeing, social relations, smartphone addiction, sleep and parents smartphone use and risk of smartphone addiction.

Detailed description

During the past fifteen years, children's leisure time spent interacting with friends in person has decreased, while the time they spend engaging with digital screens has increased. These changes in behavior can potentially have adverse effects on both their physical and mental wellbeing. This cluster-randomized controlled trial aims to evaluate an intervention aiming to increase face-to-face interaction with peers and reduce screen media use in 3rd - 4th grade-children. The study is built upon experiences gained from a recently conducted non-randomized single group feasibility trial. The feasibility trial aimed to 1) examine the feasibility of the intervention 2) examine participant recruitment and retention rates, 3) examine the feasibility of the data collection plan and completeness of the compliance and outcome assessment, and 4) obtain baseline and follow-up data on the planned full trial primary outcome. To recruit schools and afterschool clubs for the RCT, schools will be contacted directly by a member of the research team or via the municipality. Schools and their belonging afterschool clubs are eligible if they meet the following criteria: 1. the school must have an afterschool or youth club (or similar) within walking distance, 2. the afterschool club's leader and staff must be willing to develop the club by participating in a training course. After the baseline measurements the schools and afterschool clubs will be randomized into an intervention and control group. The Screen Free Time with Friends intervention is targeted children in 3rd to 4th grade and their families, school- and afterschool club staff, as well as stakeholders in the local community. It comprises an initial gathering for all stakeholders, family workshops held at the school, an exercise during a parent-school meeting, lectures conducted during school hours, a training program for afterschool club staff, and workshops involving local stakeholders. A process evaluation will be conducted to monitor the implementation of the intervention.

Interventions

BEHAVIORALScreen Free Time with Friends intervention

School-based extracurricular intervention focusing on time spent with friends and screen media use

Sponsors

University of Southern Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* the school must have an afterschool or youth club (or similar) within walking distance * the afterschool club's leader and staff must be willing to develop the club by participating in a training course.

Exclusion criteria

* no

Design outcomes

Primary

MeasureTime frameDescription
Between group difference in change in children's time spend face-to-face with peers during leisure time at weekdays and weekenddaysBaseline and 16 months follow-upChildren's time spent face-to-face with peers during leisure time at weekdays and weekenddays will be parent-reported at baseline and 16 months follow-up.

Secondary

MeasureTime frameDescription
Between group difference in change in children's time spent in afterschool clubBaseline and 16 months follow-upChildren's time spent in an afterschool club will be parent-reported at baseline and 16 months follow-up.
Between group difference in change in children's time spent with organized activities (e.g., sport, music) during leisure time at weekdays and weekenddaysBaseline and 16 months follow-upChildren's time spent with organized activities during leisure time at weekdays and weekenddays will be parent-reported at baseline and 16 months follow-up.
Between group difference in change in children's time spent with unorganized activities (e.g., playdates) during leisure time at weekdays and weekenddaysBaseline and 16 months follow-upChildren's time spent with unorganized activities (e.g., playdates) during leisure time at weekdays and weekenddays will be parent-reported at baseline and 16 months follow-up.
Between group difference in change in children's time spent using screen media alone during leisure time at weekdays and weekenddaysBaseline and 16 months follow-upChildren's time spent using screen media alone during leisure time at weekdays and weekenddays will be parent-reported at baseline and 16 months follow-up.
Between group difference in change in time in children's physical activity (any physical active behaviour) during leisure time at weekdays and weekenddaysBaseline and 16 months follow-upChildren's physical activity (any physical active behaviour) will be assessed by Axivity AX3 triaxial accelerometers worn at the thigh using two adhesive patch 24 hours/day for seven consecutive days at baseline and 16 months follow-up.

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORAnders Grøntved, PhD

Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026