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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07511465
Enrollment
60
Registered
2026-04-06
Start date
2026-01-05
Completion date
2026-06-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiving Models, Child Development, Sensory Processing, Sleep Quality

Keywords

Preschool children, Developmental status, Sensory processing, Sleep quality, Caregiving models

Brief summary

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.

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.

Interventions

None listed

Sponsors

Fenerbahce University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Developmental status assessed by the Denver II Developmental Screening TestAt 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 ProfileAt 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 QuestionnaireAt 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORSümeyye Akçay

Fenerbahçe University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026