Development, Sensory Profile, and Sleep Quality in Preschool Children Across Different Caregiving Models

April 5, 2026 updated by: Sümeyye Akçay, Fenerbahce University

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

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.

Study Overview

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

Observational

Enrollment (Estimated)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ataşehir
      • Istanbul, Ataşehir, Turkey (Türkiye), 34758
        • Recruiting
        • Fenerbahçe University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sümeyye Akçay, Asst. Prof.
        • Principal Investigator:
          • Mustafa Ferit Akkurt, Asst. Prof.
        • Principal Investigator:
          • Mine Seyyah, Asst. Prof.
        • Principal Investigator:
          • Burcu Akkurt, Asst. Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Preschool children aged 3 to 6 years living in Istanbul and raised under different caregiving models, including first-degree relatives, second-degree relatives, paid caregivers, or daycare-based care. Participants will be recruited on a voluntary basis through social media announcements, and eligible families will attend face-to-face assessment sessions at Fenerbahçe University.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Developmental status assessed by the Denver II Developmental Screening Test
Time Frame: 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.
At baseline (single assessment)
Sensory processing assessed by the Dunn Sensory Profile
Time Frame: 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.
At baseline (single assessment)
Sleep quality assessed by the Tayside Children's Sleep Questionnaire
Time Frame: 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.
At baseline (single assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sümeyye Akçay, Fenerbahçe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with other researchers because the study involves minors and includes potentially sensitive developmental and health-related information. Data will be used only for the purposes described in the approved study protocol and will be handled in accordance with applicable ethical and confidentiality requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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