Development, Sensory Profile, and Sleep Quality in Preschool Children Across Different Caregiving Models
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-6
SponsorFenerbahce University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
135 Participants
are grouped into 4 trial groupsGroup A: First-Degree Relative Care
Group B: Second-Degree Relative Care
Group C: Paid Caregiver Care
Group D: Daycare Care
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline (single assessment)2
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.
Time frame
At baseline (single assessment)3
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.
Time frame
At baseline (single assessment)Sponsors and contacts
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Source ClinicalTrials.gov