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Screen Free Time With Friends Feasibility Trial

Screen Free Time With Friends Feasibility Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05480085
Enrollment
204
Registered
2022-07-29
Start date
2022-08-19
Completion date
2024-01-19
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Screen Media Use, Time With Friends

Brief 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 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.

Interventions

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

The 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.

Sponsors

Novo Nordisk A/S
CollaboratorINDUSTRY
University of Southern Denmark
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of the interventionBaselineThe 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.

Secondary

MeasureTime frameDescription
Compliance to leisure time activities measurementThree times/week for three weeks at baseline and 6-month follow-upProportion of parents answering questions focusing on the child's afterschool club participation and time spent with friends and family during leisure time.
Compliance to objective screen media use measurementBaseline and 6-month follow-upProportion of children and parents with data on objective measured smartphone use.
Compliance to subjective screen media use measurementThree times/week for three weeks at baseline and 6-month follow-upProportion of parents answering questions focusing on the child's screen media use during leisure time.
Participant recruitment and retention rateBaseline and 6-month follow-upProportion of invited municipalities, schools, afterschool clubs and participants included in the study and proportion of municipalities, schools, afterschool clubs and participants completing the study.
Compliance to wellbeing measurementBaseline and 6-month follow-upProportion of children answering KIDSCREEN-27 questionnaire focusing on wellbeing.
Compliance to a child questionnaireBaseline and 6-month follow-upProportion of children answering a questionnaire focusing on wellbeing, screen culture in the class and family and children's social relations.
Compliance to a parent questionnaireBaseline and 6-month follow-upProportion 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.
Compliance to objective physical activity measurementBaseline and 6-month follow-upProportion 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).

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026