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

NCT07511465 | Recruiting

• 1 other identifier: FBUniversity
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development; Sensory Processing; Sleep Quality; Caregiving Models

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Developmental status assessed by the Denver II Developmental Screening Test

  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

  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

  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)

Study Arms (4)

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.

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Fenerbahçe University

Istanbul, Ataşehir, 34758, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Sümeyye Akçay

  Fenerbahçe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sümeyye Akçay, Asst. Prof.

CONTACT

+905424002553; smyye.akcy@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)