NCT06163495

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
685

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 17, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

November 17, 2023

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Between group difference in change in children's time spend face-to-face with peers during leisure time at weekdays and weekenddays

    Children'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.

    Baseline and 16 months follow-up

Secondary Outcomes (5)

  • Between group difference in change in children's time spent in afterschool club

    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 weekenddays

    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 weekenddays

    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 weekenddays

    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 weekenddays

    Baseline and 16 months follow-up

Other Outcomes (35)

  • Between group difference in change in children's time spend face-to-face with peers during leisure time at weekdays and weekenddays

    Baseline and 8 months follow-up

  • Between group difference in change in children's time spend face-to-face with peers during leisure time at weekdays and weekenddays

    8 and 16 months follow-up

  • Between group difference in change in children's time spent in afterschool club

    Baseline and 8 months follow-up

  • +32 more other outcomes

Study Arms (2)

Screen-Free Time

EXPERIMENTAL

Participants will engage in the Screen Free Time with Friends intervention that includes the following components: 1. For each participating class, children and parents will be invited to two family workshops. 2. In the beginning of 4th grade, parents will engage in a short exercise focusing on screen media use. 3. Children will engage in school hour workshops focusing on the class culture related to screen media use and face-to-face interaction with peers. 4. Afterschool club personal will engage in a training program consisting of three workshops aimed to increase participation rate in the afterschool club. 5. Local stakeholders relevant to children's leisure time will engage in two workshops to develop local actions focusing on children's engagement in face-to-face interactions with peers.

Behavioral: Screen Free Time with Friends intervention

Control

NO INTERVENTION

Participants are encouraged to continue as usual.

Interventions

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

Screen-Free Time

Eligibility Criteria

Age8 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Auraskolen, Bryndum skole

Esbjerg, Esbjerg, Denmark

Location

Auraskolen, Hjerting skole

Esbjerg, Esbjerg, Denmark

Location

Auraskolen, Sønderrisskolen

Esbjerg, Esbjerg, Denmark

Location

Bregnbjergskolen

Vojens, Haderslev, Denmark

Location

Spjald skole

Spjald, Ringkøbing, Denmark

Location

Kildeskolen

Ringsted, Ringsted, Denmark

Location

Nordbakkeskolen

Ringsted, Ringsted, Denmark

Location

Mørkhøj skole

Gladsaxe, Denmark

Location

Holmegaardskolen

Næstved, Denmark

Location

Vesterlandsskolen

Næstved, Denmark

Location

Kroggårdskolen

Odense, Denmark

Location

Næsby skole

Odense, Denmark

Location

Skt. Klemensskolen

Odense, Denmark

Location

Søhusskolen

Odense, Denmark

Location

Hvinningdalskolen

Silkeborg, Denmark

Location

Resenbro skole

Silkeborg, Denmark

Location

Sorring Skole

Silkeborg, Denmark

Location

Skolen i Skjern

Skjern, Denmark

Location

Study Officials

  • Anders Grøntved, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 17, 2023

First Posted

December 11, 2023

Study Start

November 17, 2023

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations