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临床试验/NCT06163495
NCT06163495已完成不适用

Screen Free Time With Friends: a Cluster-randomized Controlled Trial

University of Southern Denmark36 个研究点 分布在 1 个国家目标入组 685 人开始时间: 2023年11月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
685
试验地点
36
主要终点
Between group difference in change in children's time spend face-to-face with peers during leisure time at weekdays and weekenddays

研究概览

简要总结

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 children's time spend face-to-face with peers. Secondary aims are to investigate the between group difference in change in children's screen media use, physical activity, wellbeing, social relations, smartphone addiction, sleep and parents smartphone use and risk of smartphone addiction.

详细描述

During the past fifteen years, children's 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 club's 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
8 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the school must have an afterschool or youth club (or similar) within walking distance
  • the afterschool club's leader and staff must be willing to develop the club by participating in a training course.

排除标准

  • no exclusion criteria

研究组 & 干预措施

Screen-Free Time

Experimental

Participants will engage in the Screen Free Time with Friends intervention that includes the following components:

  1. For each participating class, children and parents will be invited to two family workshops.
  2. In the beginning of 4th grade, parents will engage in a short exercise focusing on screen media use.
  3. Children will engage in school hour workshops focusing on the class culture related to screen media use and face-to-face interaction with peers.
  4. Afterschool club personal will engage in a training program consisting of three workshops aimed to increase participation rate in the afterschool club.
  5. Local stakeholders relevant to children's leisure time will engage in two workshops to develop local actions focusing on children's engagement in face-to-face interactions with peers.

干预措施: Screen Free Time with Friends intervention (Behavioral)

Control

No Intervention

Participants are encouraged to continue as usual.

结局指标

主要结局

Between group difference in change in children's time spend face-to-face with peers during leisure time at weekdays and weekenddays

时间窗: Baseline and 16 months follow-up

Children's time spent face-to-face with peers during leisure time at weekdays and weekenddays will be parent-reported at baseline and 16 months follow-up.

次要结局

  • Between group difference in change in children's time spent in afterschool club(Baseline and 16 months follow-up)
  • Between group difference in change in children's time spent using screen media alone during leisure time at weekdays and weekenddays(Baseline and 16 months follow-up)
  • Between group difference in change in time in children's physical activity (any physical active behaviour) during leisure time at weekdays and weekenddays(Baseline and 16 months follow-up)
  • Between group difference in change in children's time spent with organized activities (e.g., sport, music) during leisure time at weekdays and weekenddays(Baseline and 16 months follow-up)
  • Between group difference in change in children's time spent with unorganized activities (e.g., playdates) during leisure time at weekdays and weekenddays(Baseline and 16 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anders Groentved

Professor

University of Southern Denmark

研究点 (36)

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