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Completed

NCT Number: NCT07731386

Screen Time and Language Development in Toddlers Assessed With the Bayley-4

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.

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Key information

Conditions

Language Development Child Development Screen Time

Age range

12 month–42 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Kayseri City Hospital, Pediatric Outpatient Clinics

Kayseri, 38080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 12 to 42 months at the time of assessment
  • Accompanied by a primary caregiver able to provide written informed consent
  • Caregiver able to complete the screen-time and background questionnaire
  • Turkish-speaking household
  • Complete Bayley-4 developmental assessment record

Exclusion criteria

  • Confirmed diagnosis of a neurodevelopmental disorder
  • Confirmed genetic disorder
  • Confirmed metabolic disorder
  • Confirmed chronic disease
  • Non-Turkish-speaking household
  • Incomplete assessment record or missing covariate data

Treatment and study plan

Daily Screen Media Exposure

Other

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.

Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)

Diagnostic Test

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.

Primary outcomes

  1. Bayley-4 Receptive Communication Scaled Score

    Time frame: At enrollment (single cross-sectional assessment)

    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.

Secondary outcomes

  1. Bayley-4 Expressive Communication Scaled Score

    Time frame: At enrollment (single cross-sectional assessment)

    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.

  2. Bayley-4 Cognitive, Fine Motor, and Gross Motor Scaled Scores

    Time frame: At enrollment (single cross-sectional assessment)

    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.

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Registry information

Official study title

Screen Time Exposure and Language Development in Children Aged 12-42 Months: A Cross-Sectional Study Employing the Bayley Scales of Infant and Toddler Development

Acronym: Leave blank

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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