Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163495
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2023-11-17
Brief Title:
Screen Free Time With Friends a Cluster-randomized Controlled Trial
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
Screen Free Time With Friends a Cluster-randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 The primary aim is to investigate the between group difference in change in childrens time spend face-to-face with peers Secondary aims are to investigate the between group difference in change in childrens 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 childrens 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
1 the school must have an afterschool or youth club or similar within walking distance
2 the afterschool clubs 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
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
1 the school must have an afterschool or youth club or similar within walking distance
2 the afterschool clubs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None