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

Not Applicable

Recruiting

• Conditions: Screen Media Use; Time Face to Face With Friends
• Interventions: Behavioral: Screen Free Time with Friends intervention

• Registration Number: NCT06163495
• Lead Sponsor: University of Southern Denmark

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.

Study Timeline

• Study Start: 2023-11-17
• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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 exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Screen Free Time with Friends intervention	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.

Primary Outcome Measures

Name	Time	Method
Between group difference in change in children's time spend face-to-face with peers during leisure time at weekdays and weekenddays	Baseline and 16 months follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Between group difference in change in children's time spent in afterschool club	Baseline and 16 months follow-up	Children'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 using screen media alone during leisure time at weekdays and weekenddays	Baseline and 16 months follow-up	Children'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 weekenddays	Baseline and 16 months follow-up	Children'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.
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	Children'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 weekenddays	Baseline and 16 months follow-up	Children'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.

Trial Locations

Locations (18)

Auraskolen, Hjerting skole; 🇩🇰 Esbjerg, Denmark

Spjald skole; 🇩🇰 Spjald, Ringkøbing, Denmark

Auraskolen, Bryndum skole; 🇩🇰 Esbjerg, Denmark

Skolen i Skjern; 🇩🇰 Skjern, Denmark

Bregnbjergskolen; 🇩🇰 Vojens, Haderslev, Denmark

Auraskolen, Sønderrisskolen; 🇩🇰 Esbjerg, Denmark

Mørkhøj skole; 🇩🇰 Gladsaxe, Denmark

Holmegaardskolen; 🇩🇰 Næstved, Denmark

Vesterlandsskolen; 🇩🇰 Næstved, Denmark

Kroggårdskolen; 🇩🇰 Odense, Denmark

Næsby skole; 🇩🇰 Odense, Denmark

Skt. Klemensskolen; 🇩🇰 Odense, Denmark

Søhusskolen; 🇩🇰 Odense, Denmark

Kildeskolen; 🇩🇰 Ringsted, Denmark

Nordbakkeskolen; 🇩🇰 Ringsted, Denmark

Hvinningdalskolen; 🇩🇰 Silkeborg, Denmark

Resenbro skole; 🇩🇰 Silkeborg, Denmark

Sorring Skole; 🇩🇰 Silkeborg, Denmark