Clinical trial NCT06163495: Screen Free Time With Friends: a Cluster-randomized Controlled Trial
Official title: Screen Free Time With Friends: a Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Time Face to Face With Friends
Screen Media Use
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 8
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Between group difference in change in children's time spend face-to-face with peers during leisure time at weekdays and weekenddays
timeFrame: Baseline and 16 months follow-up
Secondary outcomes:
measure: Between group difference in change in children's time spent in afterschool club
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in children's time spent with organized activities (e.g., sport, music) during leisure time at weekdays and weekenddays
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in children's time spent with unorganized activities (e.g., playdates) during leisure time at weekdays and weekenddays
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in children's time spent using screen media alone during leisure time at weekdays and weekenddays
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in time in children's physical activity (any physical active behaviour) during leisure time at weekdays and weekenddays
timeFrame: Baseline and 16 months follow-up
Other outcomes:
measure: Between group difference in change in children's time spend face-to-face with peers during leisure time at weekdays and weekenddays
timeFrame: Baseline and 8 months follow-up
measure: Between group difference in change in children's time spend face-to-face with peers during leisure time at weekdays and weekenddays
timeFrame: 8 and 16 months follow-up
measure: Between group difference in change in children's time spent in afterschool club
timeFrame: Baseline and 8 months follow-up
measure: Between group difference in change in children's time spent in afterschool club
timeFrame: 8 and 16 months follow-up
measure: Between group difference in change in children's time spent with organized activities (e.g., sport, music) during leisure time at weekdays and weekenddays
timeFrame: Baseline and 8 months follow-up
measure: Between group difference in change in children's time spent with organized activities (e.g., sport, music) during leisure time at weekdays and weekenddays
timeFrame: 8 and 16 months follow-up
measure: Between group difference in change in children's time spent with unorganized activities (e.g., playdates) during leisure time at weekdays and weekenddays
timeFrame: Baseline and 8 months follow-up
measure: Between group difference in change in children's time spent with unorganized activities (e.g., playdates) during leisure time at weekdays and weekenddays
timeFrame: 8 and 16 months follow-up
measure: Between group difference in change in children's time spent using screen media alone during leisure time at weekdays and weekenddays
timeFrame: Baseline and 8 months follow-up
measure: Between group difference in change in children's time spent using screen media alone during leisure time at weekdays and weekenddays
timeFrame: 8 and 16 months follow-up
measure: Between group difference in change in children's smartphone time at weekdays and weekenddays
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in children's smartphone time at weekdays and weekenddays
timeFrame: Baseline and 8 months follow-up
measure: Between group difference in change in children's smartphone time at weekdays and weekenddays
timeFrame: 8 and 16 months follow-up
measure: Between group difference in change in children's total screen time at weekdays and weekenddays
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in children's time in moderate to vigorous physical activity (MVPA) during leisure time at weekdays and weekenddays
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in children's wellbeing
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in children's social relations
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in school class cohesion
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in children's screen media addiction
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in children's sleep
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in parent's smartphone use at weekdays and weekenddays
timeFrame: Baseline 16 months follow-up
measure: Between group difference in change in parent's smartphone use at weekdays and weekenddays
timeFrame: Baseline and 8 months follow-up
measure: Between group difference in change in parent's smartphone use at weekdays and weekenddays
timeFrame: 8 and 16 months follow-up
measure: Between group difference in change in parent's smartphone addiction
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in children's time spent face-to-face with family during leisure time at weekdays and weekenddays
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in children's online communication
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in parent's awareness of and attitude towards screen media use
timeFrame: Baseline and 16 months follow-up
measure: Between groups difference in change in dialogue in the family
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in family screen media rules
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in conflicts rooted in screen media use (in the family)
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in parent's awareness and attitude towards children's leisure time activities
timeFrame: Baseline and 16 months follow-up
measure: Between group difference in change in dialogue among parents (in a school class)
timeFrame: Baseline and 16 months follow-up
measure: Change in perceived network and motivation among local stakeholders
timeFrame: Baseline and 16 months follow-up
measure: Amount and type of actions initiated by local stakeholders
timeFrame: 8 and 16 months follow-up
measure: Amount and type of actions initiated by the afterschool staff
timeFrame: 8 and 16 months follow-up
Locations:
city: Vojens
country: Denmark
facility: Bregnbjergskolen
state: Haderslev
city: Spjald
country: Denmark
facility: Spjald skole
state: Ringkøbing
city: Esbjerg
country: Denmark
facility: Auraskolen, Bryndum skole
city: Esbjerg
country: Denmark
facility: Auraskolen, Hjerting skole
city: Esbjerg
country: Denmark
facility: Auraskolen, Sønderrisskolen
city: Gladsaxe
country: Denmark
facility: Mørkhøj skole
city: Næstved
country: Denmark
facility: Holmegaardskolen
city: Næstved
country: Denmark
facility: Vesterlandsskolen
city: Odense
country: Denmark
facility: Kroggårdskolen
city: Odense
country: Denmark
facility: Næsby skole
city: Odense
country: Denmark
facility: Skt. Klemensskolen
city: Odense
country: Denmark
facility: Søhusskolen
city: Ringsted
country: Denmark
facility: Kildeskolen
city: Ringsted
country: Denmark
facility: Nordbakkeskolen
city: Silkeborg
country: Denmark
facility: Hvinningdalskolen
city: Silkeborg
country: Denmark
facility: Resenbro skole
city: Silkeborg
country: Denmark
facility: Sorring Skole
city: Skjern
country: Denmark
facility: Skolen i Skjern
Study officials:
affiliation: Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
name: Anders Grøntved, PhD
role: PRINCIPAL_INVESTIGATOR
References: