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临床试验/NCT07511465
NCT07511465已完成不适用

Developmental Status, Sensory Processing, and Sleep Quality in Preschool Children Across Different Caregiving Models

Fenerbahce University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Developmental status assessed by the Denver II Developmental Screening Test

研究概览

简要总结

This observational study aims to examine developmental status, sensory processing, and sleep quality in preschool children aged 3 to 6 years across different caregiving models. Children raised primarily by first-degree relatives, second-degree relatives, caregivers, or in daycare settings will be compared. Data will be collected using the Denver II Developmental Screening Test, the Dunn Sensory Profile, and the Tayside Children's Sleep Questionnaire. The study will also evaluate the relationships among developmental status, sensory processing, and sleep quality, and explore whether caregiving model is associated with differences in these outcomes.

详细描述

This observational study is designed to investigate whether different caregiving models are associated with differences in developmental status, sensory processing, and sleep quality in preschool children. Early childhood development is influenced by both biological and environmental factors, and caregiving context is considered one of the important environmental influences shaping children's developmental outcomes. In this study, caregiving model refers to the primary care arrangement in which the child has been raised, including care by first-degree relatives, second-degree relatives, a paid caregiver, or a daycare setting.

Participants will include preschool children between 3 and 6 years of age living in Istanbul. Eligible participants must have been raised within the same caregiving model for at least the previous 6 months, and parents must provide informed consent. Children with previously diagnosed neurological, developmental, or psychiatric disorders, those currently receiving treatment for sensory, sleep, or developmental problems, or those unable to complete the assessment process will be excluded.

Data will be collected through parent-report forms and standardized assessment tools. Developmental status will be assessed using the Denver II Developmental Screening Test, sensory processing will be evaluated using the Dunn Sensory Profile, and sleep quality will be assessed using the Tayside Children's Sleep Questionnaire. Recruitment will be conducted through social media announcements, and eligible families will be invited for face-to-face assessment in the Ergotherapy Department laboratory at Fenerbahçe University.

The study plans to compare four caregiving groups and to analyze whether there are significant differences between groups in developmental status, sensory processing, and sleep quality. In addition, correlations among these three outcome domains will be examined. Statistical analyses will be conducted using SPSS, with appropriate parametric or nonparametric tests depending on data distribution. The findings are expected to contribute to a better understanding of how caregiving environments may be related to child development and functional outcomes in early childhood.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Preschool children aged 3 to 6 years
  • Child has been raised within the same primary caregiving model for at least the past 6 months
  • Parent or legal guardian is willing to participate voluntarily and provide informed consent
  • Child and caregiver are able to understand Turkish and follow the study instructions

排除标准

  • Previously diagnosed neurological, developmental, or psychiatric disorder (e.g., autism spectrum disorder, attention-deficit/hyperactivity disorder, developmental delay)
  • Currently receiving treatment or therapy for sensory processing problems, sleep problems, or developmental difficulties
  • Parent or legal guardian provides incomplete or incorrect study forms
  • Child is unable to cooperate with or complete the assessment procedures

研究组 & 干预措施

First-Degree Relative Care

Preschool children aged 3 to 6 years whose primary caregiving model for at least the past 6 months has been provided by first-degree relatives, including mother and/or father.

Second-Degree Relative Care

Preschool children aged 3 to 6 years whose primary caregiving model for at least the past 6 months has been provided by second-degree relatives, such as grandparents, aunts, or uncles.

Paid Caregiver Care

Preschool children aged 3 to 6 years whose primary caregiving model for at least the past 6 months has been provided by a paid caregiver or nanny.

Daycare Care

Preschool children aged 3 to 6 years whose primary caregiving model for at least the past 6 months has been based primarily on daycare attendance.

结局指标

主要结局

Developmental status assessed by the Denver II Developmental Screening Test

时间窗: At baseline (single assessment)

Developmental status of preschool children will be assessed using the Denver II Developmental Screening Test. The Denver II is a developmental screening instrument and does not yield a single total numeric score. Results will be reported using standard test interpretation categories such as normal, suspect, or untestable.

Sensory processing assessed by the Dunn Sensory Profile

时间窗: At baseline (single assessment)

Sensory processing patterns of preschool children will be assessed using the Child Sensory Profile 2, a caregiver-reported standardized measure of sensory processing. Outcomes will be reported as raw scores for the relevant quadrants and/or sensory section scores, with corresponding normative classifications. Higher raw scores indicate more frequent sensory processing behaviors and do not necessarily indicate a better outcome.

Sleep quality assessed by the Tayside Children's Sleep Questionnaire

时间窗: At baseline (single assessment)

Sleep quality of preschool children will be assessed using the Tayside Children's Sleep Questionnaire, a parent-reported screening instrument for disorders of initiating and maintaining sleep in young children. The total score is calculated by summing the first 9 items. Scores range from 0 to 36, with higher scores indicating more sleep problems and therefore a worse outcome. A total score of 8 or higher suggests possible sleep disturbance.

次要结局

未报告次要终点

研究者

发起方
Fenerbahce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sümeyye Akçay

Asst. Prof.

Fenerbahce University

研究点 (1)

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