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临床试验/NCT07513636
NCT07513636已完成不适用

EVALUATION of SCREEN TIME in 6-18 MONTH-OLD BABIES BASED ON MOTHER'S EDUCATIONAL STATUS: A RANDOMIZED CONTROLLED TRIAL

Dokuz Eylul University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2023年5月24日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1

研究概览

简要总结

This study aims to evaluate whether educating mothers can reduce screen time in infants aged 6-18 months. Early exposure to screens has been associated with potential negative effects on child development, including language delay, attention problems, and cognitive difficulties. Therefore, reducing screen exposure during infancy is considered important.

The study is designed as an open-label, parallel-group randomized controlled trial. A total of 92 mother-infant pairs are planned to be included and randomly assigned to either an intervention group or a control group. Mothers in the intervention group will receive structured education based on recommendations from the American Academy of Pediatrics, including practical strategies to manage situations where screen use is commonly introduced (such as feeding or soothing the infant). Educational materials and follow-up guidance will also be provided. The control group will not receive any specific intervention.

Data on infants' screen exposure will be collected at baseline and at follow-up visits at 3 and 6 months using structured questionnaires. Sociodemographic characteristics will also be recorded.

The primary outcome of the study is the change in infants' screen time over the follow-up period. The findings are expected to provide evidence on whether parental education can be an effective strategy to reduce screen exposure in early childhood and support its integration into primary care practices.

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
6 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Mothers with infants aged 6-18 months
  • Infants with any level of screen exposure
  • Registered at participating Family Health Centers
  • Mothers willing to participate and provide informed consent

排除标准

  • Infants with known neurological or developmental disorders
  • Infants with chronic diseases affecting development
  • Mothers unable to participate in educational sessions
  • Incomplete follow-up or withdrawal from the study

研究者

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

Makbule Neslişah Tan

Doctor

Dokuz Eylul University

研究点 (1)

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