NCT07731386

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

July 22, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

screen timelanguage developmentBayley-4toddlerreceptive languageexpressive languagecross-sectional studyearly childhoodparental attitude

Outcome Measures

Primary Outcomes (1)

  • 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.

    At enrollment (single cross-sectional assessment)

Secondary Outcomes (2)

  • Bayley-4 Expressive Communication Scaled Score

    At enrollment (single cross-sectional assessment)

  • Bayley-4 Cognitive, Fine Motor, and Gross Motor Scaled Scores

    At enrollment (single cross-sectional assessment)

Study Arms (4)

Group 1 "0-30 min/day screen exposure"

0-30 minutes/day of screen exposure (n=41) - lowest exposure category; single Bayley-4 assessment.

Other: Daily Screen Media ExposureDiagnostic Test: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)

Group 2 "30-60 min/day screen exposure"

30-60 minutes/day of screen exposure (n=42) - single Bayley-4 assessment.

Other: Daily Screen Media ExposureDiagnostic Test: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)

Group 3 "60-120 min/day screen exposure"

60-120 minutes/day of screen exposure (n=42) - single Bayley-4 assessment.

Other: Daily Screen Media ExposureDiagnostic Test: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)

Group 4 ">120 min/day screen exposure"

More than 120 minutes/day of screen exposure (n=26) - highest exposure category; single Bayley-4 assessment.

Other: Daily Screen Media ExposureDiagnostic Test: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)

Interventions

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.

Group 1 "0-30 min/day screen exposure"Group 2 "30-60 min/day screen exposure"Group 3 "60-120 min/day screen exposure"Group 4 ">120 min/day screen exposure"

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.

Group 1 "0-30 min/day screen exposure"Group 2 "30-60 min/day screen exposure"Group 3 "60-120 min/day screen exposure"Group 4 ">120 min/day screen exposure"

Eligibility Criteria

Age12 Months - 42 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri City Hospital, Pediatric Outpatient Clinics

Kayseri, 38080, Turkey (Türkiye)

Location

Related Publications (7)

  • Bayley N, Aylward GP. Bayley Scales of Infant and Toddler Development, Fourth Edition: Technical Manual. Bloomington, MN: NCS Pearson; 2019.

    RESULT
  • Guidelines on Physical Activity, Sedentary Behaviour and Sleep for Children under 5 Years of Age. Geneva: World Health Organization; 2019. Available from http://www.ncbi.nlm.nih.gov/books/NBK541170/

  • Gastaud LM, Trettim JP, Scholl CC, Rubin BB, Coelho FT, Krause GB, Ferreira NM, de Matos MB, Pinheiro RT, de Avila Quevedo L. Screen time: Implications for early childhood cognitive development. Early Hum Dev. 2023 Aug;183:105792. doi: 10.1016/j.earlhumdev.2023.105792. Epub 2023 May 26.

  • McArthur BA, Browne D, McDonald S, Tough S, Madigan S. Longitudinal Associations Between Screen Use and Reading in Preschool-Aged Children. Pediatrics. 2021 Jun;147(6):e2020011429. doi: 10.1542/peds.2020-011429. Epub 2021 May 24.

  • Torras-Mana M, Guillamon-Valenzuela M, Ramirez-Mallafre A, Brun-Gasca C, Fornieles-Deu A. Usefulness of the Bayley scales of infant and toddler development,third edition, in the early diagnosis of language disorder. Psicothema. 2014;26(3):349-56. doi: 10.7334/psicothema2014.29.

  • Brushe ME, Haag DG, Melhuish EC, Reilly S, Gregory T. Screen Time and Parent-Child Talk When Children Are Aged 12 to 36 Months. JAMA Pediatr. 2024 Apr 1;178(4):369-375. doi: 10.1001/jamapediatrics.2023.6790.

  • Madigan S, McArthur BA, Anhorn C, Eirich R, Christakis DA. Associations Between Screen Use and Child Language Skills: A Systematic Review and Meta-analysis. JAMA Pediatr. 2020 Jul 1;174(7):665-675. doi: 10.1001/jamapediatrics.2020.0327.

Study Officials

  • Agah B ÖZTÜRK, MD

    Kayseri City Hospital, Kayseri, Türkiye

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Department of Pediatrics

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 28, 2026

Study Start

August 5, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Beginning after publication of the main results and continuing for 5 years thereafter
Access Criteria
Reasonable request to the corresponding author, subject to approval by the local ethics committee for secondary use

Locations