An observational study in Language Development, Screen Time and Child Development, sponsored by Kayseri City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 12 Months to 42 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Kayseri City Hospital · Observational
This cross-sectional study investigated whether caregiver-reported daily screen time is associated with language development in toddlers aged 12 to 42 months, measured with the Bayley-4. Receptive language was the primary outcome; expressive language, cognitive, and motor scaled scores were secondary. The study was conducted at the pediatric outpatient clinics of a tertiary care city hospital in Türkiye.
This observational, cross-sectional study examined the association between caregiver-reported daily screen time and language development, assessed with the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), in children aged 12 to 42 months attending the pediatric outpatient clinics of a tertiary care city hospital in Türkiye. The primary outcome was the Bayley-4 Receptive Communication scaled score; the Expressive Communication scaled score was the principal secondary outcome, and Cognitive, Fine Motor, and Gross Motor scaled scores were examined to assess domain specificity. Daily screen exposure was recorded on a four-level ordinal scale (0-30, 30-60, 60-120, and more than 120 minutes per day). The study was approved for children aged 1 to 4 years (12 to 48 months); enrollment was restricted to 12 to 42 months because the Bayley-4 normative range ends at 42 months, so children aged 43 to 48 months could not be scored against the instrument norms. No intervention was assigned; screen exposure was observed, not manipulated.
Kayseri City Hospital is the lead sponsor of 47 studies on the registry; 17 are open to participants now.
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Community-based sample of children aged 12 to 42 months who presented consecutively to the pediatric outpatient clinics of a tertiary care city hospital in Türkiye between August 2025 and January 2026, each accompanied by a primary caregiver. Children were enrolled irrespective of the reason for the outpatient visit provided they met the eligibility criteria. The upper age limit of 42 months reflects the normative ceiling of the Bayley-4. Of 153 screened records, 2 were excluded for missing covariate data, yielding an analytical sample of 151.
Exclusion Criteria:
0-30 minutes/day of screen exposure (n=41) - lowest exposure category; single Bayley-4 assessment.
Other: Daily Screen Media Exposure · Diagnostic Test: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)
30-60 minutes/day of screen exposure (n=42) - single Bayley-4 assessment.
Other: Daily Screen Media Exposure · Diagnostic Test: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)
60-120 minutes/day of screen exposure (n=42) - single Bayley-4 assessment.
Other: Daily Screen Media Exposure · Diagnostic Test: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)
More than 120 minutes/day of screen exposure (n=26) - highest exposure category; single Bayley-4 assessment.
Other: Daily Screen Media Exposure · Diagnostic Test: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)
Caregiver-reported total daily screen media exposure recorded on a four-level ordinal scale (0-30, 30-60, 60-120, and more than 120 minutes per day) using a structured questionnaire administered at the study visit. No exposure was assigned, allocated, or manipulated by the investigators. Applies to Cohorts 1-4.
A single standardized developmental assessment administered to each participant by one certified child development specialist in a dedicated, distraction-free examination room with the caregiver present, per Bayley-4 protocol. Mean administration time was 60-90 minutes. Receptive Communication, Expressive Communication, Cognitive, Fine Motor, and Gross Motor scaled scores were recorded. Applies to Cohorts 1-4.
Bayley-4 Receptive Communication Scaled Score
Receptive Communication subscale scaled score of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), administered once per participant by a certified examiner. Scaled scores are reported on the Bayley-4 normative metric (population mean 10, standard deviation 3). Higher scores indicate stronger receptive language performance.
Time frame: At enrollment (single cross-sectional assessment)
Bayley-4 Expressive Communication Scaled Score
Expressive Communication subscale scaled score of the Bayley-4, administered once per participant by a certified examiner, reported on the Bayley-4 normative metric (population mean 10, standard deviation 3). Higher scores indicate stronger expressive language performance.
Time frame: At enrollment (single cross-sectional assessment)
Bayley-4 Cognitive, Fine Motor, and Gross Motor Scaled Scores
Cognitive, Fine Motor, and Gross Motor subscale scaled scores of the Bayley-4, administered once per participant by a certified examiner and reported on the Bayley-4 normative metric (population mean 10, standard deviation 3). These non-language domains were recorded to characterize the domain specificity of the exposure-outcome association.
Time frame: At enrollment (single cross-sectional assessment)
Plan to share: Yes — De-identified individual participant data underlying the published results, including screen exposure category, Bayley-4 scaled scores, and sociodemographic covariates, together with the full analysis scripts, will be made available to qualified researchers. Requests will be evaluated for scientific merit and for consistency with the consent obtained from caregivers and with the approvals granted by the local ethics committee.
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Kayseri City Hospital