Screen Free Time With Friends

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

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.

Study Overview

• Status: Recruiting
• Conditions: Screen Media Use; Time Face to Face With Friends
• Intervention / Treatment: Behavioral: School-based extracurricular intervention focusing on time spent with friends and screen media use

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 Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anders Grøntved, PhD; Phone Number: +45 65504465; Email: agroentved@health.sdu.dk
• Study Contact Backup: Name: Anne Kær Gejl, PhD; Phone Number: +45 65507908; Email: akgejl@health.sdu.dk

Study Locations

• Denmark
  • Esbjerg, Denmark
    • Recruiting
    • Auraskolen, Bryndum skole
    • Contact: Nanna Kristinna Øhlenschlæger; Phone Number: +45 76 16 29 02; Email: nhl@esbjerg.dk
  • Esbjerg, Denmark
    • Recruiting
    • Auraskolen, Hjerting skole
    • Contact: Rikke Møller Jensen; Phone Number: +45 24 59 14 84; Email: j83mvubs@esbjerg.dk
  • Esbjerg, Denmark
    • Recruiting
    • Auraskolen, Sønderrisskolen
    • Contact: Camilla Dragos; Email: camdr@esbjerg.dk
  • Ringsted, Denmark
    • Recruiting
    • Kildeskolen
    • Contact: Anne Katrine Blond; Phone Number: +45 24 76 48 79; Email: ankbl@ringsted.dk
  • Ringsted, Denmark
    • Recruiting
    • Nordbakkeskolen
    • Contact: Martin Reinholdt Fogh; Phone Number: +45 21 43 80 08; Email: marfo@ringsted.dk
  • Haderslev
    • Vojens, Haderslev, Denmark
      • Recruiting
      • Bregnbjergskolen
      • Contact: Claus Hillebrand Jensen; Phone Number: +45 29 74 34 35; Email: clhi@haderslev.dk
  • Ringkøbing
    • Spjald, Ringkøbing, Denmark
      • Recruiting
      • Spjald skole
      • Contact: Kirsten Vesterbæk; Phone Number: +45 2425 8789; Email: Kirsten.vesterbaek@rksk.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: School-based extracurricular intervention focusing on time spent with friends and screen media use	Behavioral: School-based extracurricular intervention focusing on time spent with friends and screen media use; The intervention includes the following components: For each participating class, children and parents will engage in two family workshops. The purpose of these events is to support the class and families in establishing and maintaining a leisure time behavior among children with less solitary screen usage and more face-to-face interaction with peers.; In the beginning of 4th grade, parents will engage in a short exercise focusing on screen media dilemmas.; Children will engage in school hour workshops focusing on the class culture related to screen media use and face-to-face interaction with peers.; Afterschool club personal will engage in a training program consisting of three workshops aimed to increase participation rate in the afterschool club.; 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.
No Intervention: Control group; Participants are encouraged to continue as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between group difference in change in children's time spent in afterschool club	Children's time spent in an afterschool club will be parent-reported at baseline and 16 months follow-up.	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	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.	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	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.	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	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.	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	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.	Baseline and 16 months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 8 months follow-up.	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	Children's time spent face-to-face with peers during leisure time at weekdays and weekenddays will be parent-reported at 8 and 16 months follow-up	8 and 16 months follow-up
Between group difference in change in children's time spent in afterschool club	Children's time spent in an afterschool club will be parent-reported baseline and 8 months follow-up.	Baseline and 8 months follow-up
Between group difference in change in children's time spent in afterschool club	Children's time spent in an afterschool club will be parent-reported at 8 and 16 months follow-up.	8 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	Children's time spent with organized activities during leisure time at weekdays and weekenddays will be parent-reported at baseline and 8 months follow-up.	Baseline and 8 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	Children's time spent with organized activities during leisure time at weekdays and weekenddays will be parent-reported at 8 and 16 months follow-up.	8 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	Children's time spent with unorganized activities (e.g., playdates) during leisure time at weekdays and weekenddays will be parent-reported at baseline and 8 months follow-up.	Baseline and 8 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	Children's time spent with unorganized activities (e.g., playdates) during leisure time at weekdays and weekenddays will be parent-reported 8 and 16 months follow-up.	8 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	Children's time spent using screen media alone during leisure time at weekdays and weekenddays will be parent-reported at baseline and 8 months follow-up.	Baseline and 8 months follow-up
Between group difference in change in children's time spent using screen media alone during leisure time at weekdays and weekenddays	Children's time spent using screen media alone during leisure time at weekdays and weekenddays will be parent-reported at 8 and 16 months follow-up.	8 and 16 months follow-up
Between group difference in change in children's smartphone time at weekdays and weekenddays	Children's smartphone time at weekdays and weekenddays will be assessed objectively continuously during the intervention by an application installed on the participants devices and extrapolated from their smartphone.	Baseline and 16 months follow-up
Between group difference in change in children's smartphone time at weekdays and weekenddays	Children's smartphone time at weekdays and weekenddays will be assessed objectively continuously during the intervention by an application installed on the participants devices and extrapolated from their smartphone.	Baseline and 8 months follow-up
Between group difference in change in children's smartphone time at weekdays and weekenddays	Children's smartphone time at weekdays and weekenddays will be assessed objectively continuously during the intervention by an application installed on the participants devices and extrapolated from their smartphone.	8 and 16 months follow-up
Between group difference in change in children's total screen time at weekdays and weekenddays	Children's total screen time at weekdays and weekenddays will be parent-reported at baseline and follow-up. Also, children's screen use before bedtime will be parent-reported at baseline and 16 months follow-up.	Baseline and 16 months follow-up
Between group difference in change in children's time in moderate to vigorous physical activity (MVPA) during leisure time at weekdays and weekenddays	Children's moderate to vigorous physical activity (MVPA) during leisure time at weekdays and weekenddays 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.	Baseline and 16 months follow-up
Between group difference in change in children's social relations	Social network analysis will be employed to examine the children's social relationships within the class.	Baseline and 16 months follow-up
Between group difference in change in school class cohesion	Children will answer questions related to school class cohesion (e.g., sense of belonging) at baseline and 16 months follow-up.	Baseline and 16 months follow-up
Between group difference in change in children's screen media addiction	Children's screen media addiction will be parent-reported using the Problematic Media Use Measure Short Form (PMUM-SF).	Baseline and 16 months follow-up
Between group difference in change in children's sleep	Children's sleep will be assessed seven consecutive days at baseline and 16 months follow-up using the Axivity AX3 triaxial accelerometers. The objective measures of sleep duration will be supplemented by few questions about sleep in the parental questionnaire.	Baseline and 16 months follow-up
Between group difference in change in parent's smartphone use at weekdays and weekenddays	Parent's smartphone time at weekdays and weekenddays will be assessed objectively continuously during the intervention by an application installed on the participants devices.	Baseline 16 months follow-up
Between group difference in change in parent's smartphone use at weekdays and weekenddays	Parent's smartphone time at weekdays and weekenddays will be assessed objectively continuously during the intervention by an application installed on the participants devices.	Baseline and 8 months follow-up
Between group difference in change in parent's smartphone use at weekdays and weekenddays	Parent's smartphone time at weekdays and weekenddays will be assessed objectively continuously during the intervention by an application installed on the participants devices.	8 and 16 months follow-up
Between group difference in change in parent's smartphone addiction	The smartphone addiction scale - short version (SAS-SV) consisting of 10 items rated on a 6-point Likert scale (strongly disagree to strongly agree) will be used to assess the level of risk of smartphone addiction among parents.	Baseline and 16 months follow-up
Between group difference in change in children's time spent face-to-face with family during leisure time at weekdays and weekenddays	Children's time spent face-to-face with family during leisure time at weekdays and weekenddays will be self-reported and parent-reported at baseline and 16 months follow-up.	Baseline and 16 months follow-up
Between group difference in change in children's online communication	Children will answer questions related to online communication such as amount and experiences at baseline and 16 months follow-up.	Baseline and 16 months follow-up
Between group difference in change in parent's awareness of and attitude towards screen media use	Parents will answer questions about their awareness and attitude towards screen media use at baseline and 16 months follow-up.	Baseline and 16 months follow-up
Between groups difference in change in dialogue in the family	At baseline and 16 months follow-up, parents will answer questions about whether and how parents and children discuss/talk about aspects related to screen media use.	Baseline and 16 months follow-up
Between group difference in change in family screen media rules	At baseline and 16 months follow-up, parents will answer questions about family screen media rules, which also encompass the children's satisfaction with these (potential) rules.	Baseline and 16 months follow-up
Between group difference in change in conflicts rooted in screen media use (in the family)	At baseline and 16 months follow-up, parents will answer questions about the frequency of conflicts rooted in screen media use in the family.	Baseline and 16 months follow-up
Between group difference in change in parent's awareness and attitude towards children's leisure time activities	At baseline and 16 months follow-up, parents will answer questions about awareness and attitude towards children's leisure time activities including the afterschool program.	Baseline and 16 months follow-up
Between group difference in change in dialogue among parents (in a school class)	At baseline and 16 months follow-up, parents will answer questions about whether parents in the school class discuss aspects related to screen media use, the afterschool program, or leisure time activities.	Baseline and 16 months follow-up
Change in perceived network and motivation among local stakeholders	At baseline and 16 months follow-up, local stakeholders in the intervention group will answer questions related to their perceived social network and motivation for improving children's opportunities to spend time face-to-face with peers in the local community.	Baseline and 16 months follow-up
Amount and type of actions initiated by local stakeholders	At 8 and 16 months follow-up local stakeholders in the intervention group will answer questions about the amount and type of local actions initiated as a result of the local workshops.	8 and 16 months follow-up
Amount and type of actions initiated by the afterschool staff	At 8 and 16 months follow-up the afterschool staff in the intervention group will answer questions about the amount and type of actions initiated as a result of the training program.	8 and 16 months follow-up
Between group difference in change in children's wellbeing	The wellbeing of the children will be measured using the Danish version of the Strengths and Difficulties Questionnaire (SDQ) for teachers at baseline and 18 months follow-up. In addition, children's wellbeing will be self-reported using a child questionnaire including the Cantril's scale rating from 10 (the best possible life) to 0 (the worst possible life). Furthermore, children will answer a question about loneliness answered on a four-point Likert scale.	Baseline and 16 months follow-up

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Investigators: Principal Investigator: Anders Grøntved, PhD, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 10, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NNF20SH0062965_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No