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临床试验/CTRI/2025/07/089966
CTRI/2025/07/089966尚未招募不适用

Impact of School and Home-Based Strategies in Reducing Screen Time Among Pre-school Children: A Clustered Randomized Controlled Trial

Dr Anshu Singh1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
Reduction in daily screen time (minutes per day) measured via parental self-report and a validated screen time log diary.

研究概览

简要总结

This three-arm cluster randomized controlled trial aims to evaluate the effectiveness of school-based and parent-based interventions in reducing daily screen time among 3–6-year-old preschool children in Akola city, Maharashtra. A total of 12 pre-primary schools will be randomly allocated to one of three groups: (1) Control group (no intervention other than educational module), (2) School Recommendations + Teacher Education, and (3) Parent Education via structured modules and workshops. The study will measure changes in daily screen exposure (primary outcome) and behavioural parameters such as attention span, social interaction, sleep patterns, and engagement in non-screen activities (secondary outcomes) at baseline, 3 months, and 6 months. The sample size is 300 children (100 per arm), accounting for clustering effects. The trial includes capacity-building for teachers and awareness modules for parents, and it seeks to generate evidence-based strategies for promoting healthier screen habits in early childhood. Data will be analyzed using mixed-effect regression models and intention-to-treat analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Schools willing to participate in the study.
  • Children aged 3-6 years and their parental/guardian assent for participation.
  • Parent and teachers those giving consent for the study.

排除标准

  • Children with developmental delays affecting screen time behaviours.

结局指标

主要结局

Reduction in daily screen time (minutes per day) measured via parental self-report and a validated screen time log diary.

时间窗: Reduction in daily screen time (30-minutes per day)

次要结局

  • Behavioural changes in children(Attention span,)

研究者

发起方
Dr Anshu Singh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anshu Singh

Government Medical College, Akola

研究点 (1)

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