Screen Media UseNCT05480085
Screen Free Time With Friends Feasibility Trial
A study testing School-based extracurricular intervention focusing on screen media use and time spent with friends in people with Screen Media Use and Time With Friends, run by University of Southern Denmark at 3 sites in Denmark.
Trial summary
The Screen Free Time with Friends Feasibility Trial is a study designed to inform development of a definitive trial. The feasibility trial aims to 1) examine the feasibility of an intervention aimed to limit recreational screen media use and promote more time with peers after school and during weekends among 10-11… Read more about this study
- Who is it for?
- Ages 8 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Screen Media Use, Time With Friends
- What is being tested?
- School-based extracurricular intervention focusing on screen media use and time spent with friends
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 3 sitesDenmark
- Study dates
- 19 Aug 2022to 19 Jan 2024
- 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 distance between the school and the related afterschool club is in walking and cycling distance
- the afterschool club must have potential for improvement (assessed by the municipality)
- the afterschool club personal must have a wish to develop the afterschool club
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Nyborg municipality
Nyborg
Odense municipality
Odense
Sorø municipality
Sorø
About this study
The Screen Free Time with Friends Feasibility Trial is a study designed to inform development of a definitive trial. The feasibility trial aims to 1) examine the feasibility of an intervention aimed to limit recreational screen media use and promote more time with peers after school and during weekends among 10-11 year old children, 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. The Screen Free Time with Friends Feasibility Trial will be conducted as a non-randomized single group feasibility trial including children, their parents and school and afterschool personal from 3rd grade school classes from different schools in the Region of Southern Denmark. The goal is to include a representative sample of children and parents in the participating 3rd grades, and thus there will be no individual level inclusion and exclusion criteria. A process evaluation and outcome measurements will be conducted to evaluate the feasibility and acceptability of the intervention, the data collection plan, and compliance. A baseline- and follow-up assessment will be carried out for some measurements, while others will be collected continuously during the intervention period.
- Conditions
- Screen Media Use, Time With Friends
- Being tested
- School-based extracurricular intervention focusing on screen media use and time spent with friends
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-based extracurricular intervention focusing on screen media use and time spent with friendsBehavioural
The intervention includes the following components:
- Within each class parents will engage in two meetings combining education and parent-to-parent communication about 1) the children's leisure time activities, and 2) family and class screen time culture. Parents will engage in a short exercise focusing on screen media dilemmas conducted by the teacher in the beginning of 4th grade.
- Children will engage in school hour workshops focusing on the class culture related to screen media use and leisure time activities.
- Afterschool club personal will engage in mini actions learning program consisting of three workshops aimed to increase participation rate in the afterschool club.
- Local stakeholders, e.g., parents, school- and afterschool club personal and others relevant to children's leisure time (e.g., sports clubs) will engage in workshops to adjust the predetermined intervention components (1-3 above) to fit their local context and to develop a local action plan.
| Study group | Role | What they receive |
|---|---|---|
| School-based extracurricular intervention focusing on screen media use and time spent with friends | Experimental | Not described Receives: Behavioral: School-based extracurricular intervention focusing on screen media use and time spent with friends |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention
The feasibility of the intervention is evaluated using process evaluation inspired by the RE-AIM framework. Questionnaires to parents and local workshop participants focusing on the intervention and measurements will be used to assess acceptability.
Measured: Baseline
Feasibility of the intervention
The feasibility of the intervention is evaluated using process evaluation inspired by the RE-AIM framework. Questionnaires and interviews with parents, local workshop participants, school and afterschool club personal, municipality and research team focusing on the recruitment process, intervention and measurements will be used to assess acceptability.
Measured: After completion of different intervention components
Secondary outcomes (8)
Participant recruitment and retention rate
Proportion of invited municipalities, schools, afterschool clubs and participants included in the study and proportion of municipalities, schools, afterschool clubs and participants completing the study.
Measured: Baseline and 6-month follow-up
Compliance to leisure time activities measurement
Proportion of parents answering questions focusing on the child's afterschool club participation and time spent with friends and family during leisure time.
Measured: Three times/week for three weeks at baseline and 6-month follow-up
Compliance to objective screen media use measurement
Proportion of children and parents with data on objective measured smartphone use.
Measured: Baseline and 6-month follow-up
Compliance to subjective screen media use measurement
Proportion of parents answering questions focusing on the child's screen media use during leisure time.
Measured: Three times/week for three weeks at baseline and 6-month follow-up
Compliance to objective physical activity measurement
Proportion of children wearing the accelerometer (Axivity AX3) for at least four out of seven measurements days at baseline and follow-up (at least one day must be a weekend day).
Measured: Baseline and 6-month follow-up
Compliance to wellbeing measurement
Proportion of children answering KIDSCREEN-27 questionnaire focusing on wellbeing.
Measured: Baseline and 6-month follow-up
Compliance to a child questionnaire
Proportion of children answering a questionnaire focusing on wellbeing, screen culture in the class and family and children's social relations.
Measured: Baseline and 6-month follow-up
Compliance to a parent questionnaire
Proportion of parents answering the parent questionnaire including questions on background informations, their child's and family's physical activity and screen media habits and children's and parents screen media addiction.
Measured: Baseline and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start19 Aug 2022
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
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 Screen Media UseStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- 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
- NCT05480085
- Sponsor's protocol ID
- NNF20SH0062965
- Status last verified
- Jan 2024
- First submitted
- 21 Jun 2022
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sorensen SO, Larsen KT, Hoy TV, Hansen ABG, Jago R, Kristensen PL, Toftager M, Grontved A, Gejl AK. Study protocol for the Screen-Free Time with Friends Feasibility Trial. Pilot Feasibility Stud. 2024 Feb 19;10(1):33. doi: 10.1186/s40814-024-01462-y.
PubMed 38374084
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screen Free Time With Friends Feasibility Trial
- ClinicalTrials.gov ID
- NCT05480085
- Acronym / sponsor ID
- NNF20SH0062965
- Conditions
- Screen Media Use, Time With Friends
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 29 Jul 2022 (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 Feasibility Trial is a study designed to inform development of a definitive trial. The feasibility trial aims to 1) examine the feasibility of an intervention aimed to limit recreational screen media use and promote more time with peers after school and during weekends among 10-11 year old children, 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. The Screen Free Time with Friends Feasibility Trial will be conducted as a non-randomized single group feasibility trial including children, their parents and school and afterschool personal from 3rd grade school classes from different schools in the Region of Southern Denmark. The goal is to include a representative sample of children and parents in the participating 3rd grades, and thus there will be no individual level inclusion and exclusion criteria. A process evaluation and outcome measurements will be conducted to evaluate the feasibility and acceptability of the intervention, the data collection plan, and compliance. A baseline- and follow-up assessment will be carried out for some measurements, while others will be collected continuously during the intervention period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| School-based extracurricular intervention focusing on screen media use and time spent with friends | Experimental | Behavioral: School-based extracurricular intervention focusing on screen media use and time spent with friends |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- the distance between the school and the related afterschool club is in walking and cycling distance
- the afterschool club must have potential for improvement (assessed by the municipality)
- the afterschool club personal must have a wish to develop the afterschool club
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| School-based extracurricular intervention focusing on screen media use and time spent with friendsThe intervention includes the following components: 1. Within each class parents will engage in two meetings combining education and parent-to-parent communication about 1) the children's leisure time activities, and 2) family and class screen time culture. Parents will engage in a short exercise focusing on screen media dilemmas conducted by the teacher in the beginning of 4th grade. 2. Children will engage in school hour workshops focusing on the class culture related to screen media use and leisure time activities. 3. Afterschool club personal will engage in mini actions learning program consisting of three workshops aimed to increase participation rate in the afterschool club. 4. Local stakeholders, e.g., parents, school- and afterschool club personal and others relevant to children's leisure time (e.g., sports clubs) will engage in workshops to adjust the predetermined intervention components (1-3 above) to fit their local context and to develop a local action plan. | Behavioural | School-based extracurricular intervention focusing on screen media use and time spent with friends |
Primary outcome
Feasibility of the intervention
Time frame: Baseline
The feasibility of the intervention is evaluated using process evaluation inspired by the RE-AIM framework. Questionnaires to parents and local workshop participants focusing on the intervention and measurements will be used to assess acceptability.
Feasibility of the intervention
Time frame: After completion of different intervention components
The feasibility of the intervention is evaluated using process evaluation inspired by the RE-AIM framework. Questionnaires and interviews with parents, local workshop participants, school and afterschool club personal, municipality and research team focusing on the recruitment process, intervention and measurements will be used to assess acceptability.
8 secondary outcomes
Participant recruitment and retention rate
Time frame: Baseline and 6-month follow-up
Compliance to leisure time activities measurement
Time frame: Three times/week for three weeks at baseline and 6-month follow-up
Compliance to objective screen media use measurement
Time frame: Baseline and 6-month follow-up
Compliance to subjective screen media use measurement
Time frame: Three times/week for three weeks at baseline and 6-month follow-up
Compliance to objective physical activity measurement
Time frame: Baseline and 6-month follow-up
Compliance to wellbeing measurement
Time frame: Baseline and 6-month follow-up
Compliance to a child questionnaire
Time frame: Baseline and 6-month follow-up
Compliance to a parent questionnaire
Time frame: Baseline and 6-month 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 1 Feb 2024.
- Derived from this study: PubMed 38374084Sorensen SO, Larsen KT, Hoy TV, Hansen ABG, Jago R, Kristensen PL, Toftager M, Grontved A, Gejl AK. Study protocol for the Screen-Free Time with Friends Feasibility Trial. Pilot Feasibility Stud. 2024 Feb 19;10(1):33. doi: 10.1186/s40814-024-01462-y.
- Individual participant dataSharing planned: No
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Enrolling by invitationObservational study
Impact of Problematic Media Use on Postoperative Pain in Children Undergoing Tonsillectomy
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SCREENS: Sleep, Circadian Rhythms, and Electronics in the EveNing Study
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EFFECT OF SCREEN ADDICTION EDUCATION FOR PARENTS OF CHILDREN AGED 4-6 ON PROBLEMATIC MEDIA USE AND DIGITAL PARENTING SELF-EFFICACY
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-based extracurricular intervention focusing on screen media use and time spent with friends in people with Screen Media Use and Time With Friends, run by University of Southern Denmark at 3 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 3 inclusion and 0 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 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Feasibility of the intervention (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT05480085, 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 1 Feb 2024.