Child DevelopmentNCT07511465
Development, Sensory Profile, and Sleep Quality in Preschool Children Across Different Caregiving Models
An observational study of Child Development and Sensory Processing, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Sensory Processing, Sleep Quality
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fenerbahçe University
Istanbul, Ataşehir, 34758
About this study
Official title: 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.
Read the 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.
- Keywords
- Preschool children, Developmental status, Sensory processing, Sleep quality, Caregiving models
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start5 Jan 2026
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye Akçay, Fenerbahce University
- Investigators
- Sümeyye Akçay, Principal investigator, Fenerbahçe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511465
- Sponsor's protocol ID
- FBUniversity
- Status last verified
- Jul 2026
- First submitted
- 30 Mar 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Status, Sensory Processing, and Sleep Quality in Preschool Children Across Different Caregiving Models
- ClinicalTrials.gov ID
- NCT07511465
- Acronym / sponsor ID
- FBUniversity
- Keywords
- Preschool children, Developmental status, Sensory processing, Sleep quality, Caregiving models
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sümeyye Akçay principal investigator
Fenerbahçe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development and Sensory Processing, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental status assessed by the Denver II Developmental Screening Test (time frame: At baseline (single assessment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.