Screen Free Time With Friends Feasibility Trial

Study Overview
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Brief Summary
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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.

Official Title
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Screen Free Time With Friends Feasibility Trial

Conditions
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Screen Media Use, Time With Friends

Intervention / Treatment
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* Behavioral: School-based extracurricular intervention focusing on screen media use and time spent with friends


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: School-based extracurricular intervention focusing on screen media use and time spent with friends<br> | Behavioral: School-based extracurricular intervention focusing on screen media use and time spent with friends<br>* 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. 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 a meeting focusing on e.g. activity development and implementation (and how to engage the children in this process) and effective strategies to engage parents. This workshop aims 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 and school and afterschool club personal focusing on the intervention and measurements will be used to assess acceptability. | 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 and school and afterschool club personal focusing on the intervention and measurements will be used to assess acceptability. | 4-month follow-up | 
| 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 and school and afterschool club personal focusing on the intervention and measurements will be used to assess acceptability. | 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant recruitment and retention rate | Proportion of invited participants included in the study and proportion of participants completing the study. | 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). | 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. | Baseline and 6-month follow-up | 
| Compliance to subjective screen media use measurement | Proportion of parents answering the daily screen-media questionnaire. | Baseline and 6-month follow-up | 
| Compliance to leisure time activities measurement | Proportion of parents answering a weekly questionnaire focusing on the child's afterschool club participation and time spent with friends during leisure time. | 6-months (intervention period) | 
| Compliance to wellbeing measurement | Proportion of answers to a wellbeing questionnaire. | Baseline and 6-month follow-up | 
| Compliance to screen media addiction measurement | Proportion of answers to a questionnaire focusing on the children's addiction to screen media. | Baseline and 6-month follow-up | 
| Compliance to social relations measurement | Proportion of answers to a questionnaire focusing on children's social relations. | Baseline and 6-month follow-up | 
| Compliance to SCREENS-Q | Proportion of parents answering the SCREENS-Q. | Baseline and 6-month follow-up |