- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07511465
Development, Sensory Profile, and Sleep Quality in Preschool Children Across Different Caregiving Models
Developmental Status, Sensory Processing, and Sleep Quality in Preschool Children Across Different Caregiving Models
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sümeyye Akçay, Asst. Prof.
- Phone Number: +905424002553
- Email: smyye.akcy@gmail.com
Study Locations
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Ataşehir
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Istanbul, Ataşehir, Turkey (Türkiye), 34758
- Recruiting
- Fenerbahçe University
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Contact:
- Sümeyye Akçay, Asst. Prof.
- Phone Number: +905424002553
- Email: smyye.akcy@gmail.com
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Contact:
- Email: smyye.akcy@gmail.com
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Principal Investigator:
- Sümeyye Akçay, Asst. Prof.
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Principal Investigator:
- Mustafa Ferit Akkurt, Asst. Prof.
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Principal Investigator:
- Mine Seyyah, Asst. Prof.
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Principal Investigator:
- Burcu Akkurt, Asst. Prof.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Developmental status assessed by the Denver II Developmental Screening Test
Time Frame: At baseline (single assessment)
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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.
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At baseline (single assessment)
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Sensory processing assessed by the Dunn Sensory Profile
Time Frame: At baseline (single assessment)
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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.
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At baseline (single assessment)
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Sleep quality assessed by the Tayside Children's Sleep Questionnaire
Time Frame: At baseline (single assessment)
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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.
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At baseline (single assessment)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sümeyye Akçay, Fenerbahçe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FBUniversity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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