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

NCT ID: NCT06163495

Last Updated: 2024-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-17

Study Completion Date

2025-07-01

Brief Summary

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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

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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.

Conditions

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Time Face to Face With Friends Screen Media Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Screen Free Time with Friends intervention

Intervention Type BEHAVIORAL

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

Control group

Participants are encouraged to continue as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Screen Free Time with Friends intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Anders Groentved

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Grøntved, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Bregnbjergskolen

Vojens, Haderslev, Denmark

Site Status RECRUITING

Spjald skole

Spjald, Ringkøbing, Denmark

Site Status RECRUITING

Auraskolen, Bryndum skole

Esbjerg, , Denmark

Site Status RECRUITING

Auraskolen, Hjerting skole

Esbjerg, , Denmark

Site Status RECRUITING

Auraskolen, Sønderrisskolen

Esbjerg, , Denmark

Site Status RECRUITING

Mørkhøj skole

Gladsaxe, , Denmark

Site Status RECRUITING

Holmegaardskolen

Næstved, , Denmark

Site Status RECRUITING

Vesterlandsskolen

Næstved, , Denmark

Site Status RECRUITING

Kroggårdskolen

Odense, , Denmark

Site Status RECRUITING

Næsby skole

Odense, , Denmark

Site Status RECRUITING

Skt. Klemensskolen

Odense, , Denmark

Site Status RECRUITING

Søhusskolen

Odense, , Denmark

Site Status RECRUITING

Kildeskolen

Ringsted, , Denmark

Site Status RECRUITING

Nordbakkeskolen

Ringsted, , Denmark

Site Status RECRUITING

Hvinningdalskolen

Silkeborg, , Denmark

Site Status RECRUITING

Resenbro skole

Silkeborg, , Denmark

Site Status RECRUITING

Sorring Skole

Silkeborg, , Denmark

Site Status RECRUITING

Skolen i Skjern

Skjern, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Anders Grøntved, PhD

Role: CONTACT

+45 65504465

Anne Kær Gejl, PhD

Role: CONTACT

+45 65507908

Facility Contacts

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Claus Hillebrand Jensen

Role: primary

+45 29 74 34 35

Kirsten Vesterbæk

Role: primary

+45 2425 8789

Nanna Kristinna Øhlenschlæger

Role: primary

+45 76 16 29 02

Rikke Møller Jensen

Role: primary

+45 24 59 14 84

Camilla Dragos

Role: primary

Bodil Dehli

Role: primary

+45 27 21 04 94

Lasse Dalén Andersen

Role: primary

+45 21 37 19 96

Martin Aamand Nielsen

Role: primary

+45 21 54 01 38

Gina Kranker

Role: primary

+4521341074

Rikke Møller Dichmann

Role: primary

Lise-Lotte Just

Role: backup

Maria Maag Nielsen

Role: primary

+45 22 94 79 19

Kristian Munch Ladefoged

Role: primary

+4560173575

Anne Katrine Blond

Role: primary

+45 24 76 48 79

Martin Reinholdt Fogh

Role: primary

+45 21 43 80 08

Thomas Charlie Jensen

Role: primary

Michael Viborg

Role: primary

+45 40 29 63 17

Anne Holmgård Christensen

Role: primary

+458970 2770

René Nordentoft Madsen

Role: primary

+45 99 74 27 19

Other Identifiers

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NNF20SH0062965_2

Identifier Type: -

Identifier Source: org_study_id

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