Time Face to Face With FriendsNCT06163495
Screen Free Time With Friends: a Cluster-randomized Controlled Trial
A study testing Screen Free Time with Friends intervention in people with Time Face to Face With Friends and Screen Media Use, run by University of Southern Denmark at 18 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Time Face to Face With Friends, Screen Media Use
- What is being tested?
- Screen Free Time with Friends intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 685 participants
- Where
- 18 sitesDenmark
- Study dates
- 17 Nov 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- no exclusion criteria
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Denmark18 sites
Auraskolen, Bryndum skole
Esbjerg, Esbjerg
Auraskolen, Hjerting skole
Esbjerg, Esbjerg
Auraskolen, Sønderrisskolen
Esbjerg, Esbjerg
Mørkhøj skole
Gladsaxe
Holmegaardskolen
Næstved
Vesterlandsskolen
Næstved
Kroggårdskolen
Odense
Næsby skole
Odense
Skt. Klemensskolen
Odense
Søhusskolen
Odense
Kildeskolen
Ringsted, Ringsted
Nordbakkeskolen
Ringsted, Ringsted
Hvinningdalskolen
Silkeborg
Resenbro skole
Silkeborg
Sorring Skole
Silkeborg
Skolen i Skjern
Skjern
Spjald skole
Spjald, Ringkøbing
Bregnbjergskolen
Vojens, Haderslev
About this study
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.
Read the 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:
- 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.
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
- Time Face to Face With Friends, Screen Media Use
- Being tested
- Screen Free Time with Friends intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screen Free Time with Friends interventionBehavioural
School-based extracurricular intervention focusing on time spent with friends and screen media use
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Screen Free Time with Friends intervention |
| Control | No intervention | Participants are encouraged to continue as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 16 months follow-up
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 16 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start17 Nov 2023
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Time Face to Face With FriendsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 685 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Groentved, University of Southern Denmark
- Investigators
- Anders Grøntved, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163495
- Sponsor's protocol ID
- NNF20SH0062965_2
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lange SK, Sorensen SO, Hoy TV, Larsen KT, Hansen ABG, Jago R, Kristensen PL, Grontved A, Toftager M, Gejl AK. Screen-Free Time With Friends to Promote Face-to-Face Peer Interaction and Reduce Recreational Screen Use Among Children Aged 9-11 Years: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 5;15:e84831. doi: 10.2196/84831.
PubMed 42247658
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screen Free Time With Friends: a Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06163495
- Acronym / sponsor ID
- NNF20SH0062965_2
- Conditions
- Time Face to Face With Friends, Screen Media Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 685 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screen-Free Time | Experimental | Behavioral: Screen Free Time with Friends interventionParticipants 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. |
| Control | No intervention | –Participants are encouraged to continue as usual. |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screen Free Time with Friends interventionSchool-based extracurricular intervention focusing on time spent with friends and screen media use | Behavioural | Screen-Free Time |
Primary outcome
Between group difference in change in children's time spend face-to-face with peers during leisure time at weekdays and weekenddays
Time frame: 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.
5 secondary outcomes
Between group difference in change in children's time spent in afterschool club
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 16 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Derived from this study: PubMed 42247658Lange SK, Sorensen SO, Hoy TV, Larsen KT, Hansen ABG, Jago R, Kristensen PL, Grontved A, Toftager M, Gejl AK. Screen-Free Time With Friends to Promote Face-to-Face Peer Interaction and Reduce Recreational Screen Use Among Children Aged 9-11 Years: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 5;15:e84831. doi: 10.2196/84831.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Grøntved, PhD principal investigator
University of Southern Denmark
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screen Free Time with Friends intervention in people with Time Face to Face With Friends and Screen Media Use, run by University of Southern Denmark at 18 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between group difference in change in children's time spend face-to-face with peers during leisure time at weekdays and weekenddays (time frame: Baseline and 16 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06163495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.