Screen Free Time With Friends Feasibility Trial

Not Applicable

Completed

• Conditions: Screen Media Use; Time With Friends
• Interventions: Behavioral: School-based extracurricular intervention focusing on screen media use and time spent with friends

• Registration Number: NCT05480085
• Lead Sponsor: University of Southern Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-29
• Study Start: 2022-08-19
• Status Verified: 2024-01
• Primary Completion: 2024-01-19
• Study Completion: 2024-01-19
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention	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.

Secondary Outcome Measures

Name	Time	Method
Compliance to a parent questionnaire	Baseline and 6-month follow-up	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.
Participant recruitment and retention rate	Baseline and 6-month follow-up	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.
Compliance to leisure time activities measurement	Three times/week for three weeks at baseline and 6-month follow-up	Proportion of parents answering questions focusing on the child's afterschool club participation and time spent with friends and family during leisure time.
Compliance to wellbeing measurement	Baseline and 6-month follow-up	Proportion of children answering KIDSCREEN-27 questionnaire focusing on wellbeing.
Compliance to a child questionnaire	Baseline and 6-month follow-up	Proportion of children answering a questionnaire focusing on wellbeing, screen culture in the class and family and children's social relations.
Compliance to objective physical activity measurement	Baseline and 6-month follow-up	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).
Compliance to objective screen media use measurement	Baseline and 6-month follow-up	Proportion of children and parents with data on objective measured smartphone use.
Compliance to subjective screen media use measurement	Three times/week for three weeks at baseline and 6-month follow-up	Proportion of parents answering questions focusing on the child's screen media use during leisure time.

Trial Locations

Locations (3)

Nyborg municipality; 🇩🇰 Nyborg, Denmark

Odense municipality; 🇩🇰 Odense, Denmark

Sorø municipality; 🇩🇰 Sorø, Denmark