Language DevelopmentLeave blankNCT07731386
Screen Time and Language Development in Toddlers Assessed With the Bayley-4
An observational study of Language Development and Screen Time, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 42 monthsHealthy volunteers can take part
- Conditions the study is for
- Language Development, Screen Time, Child Development
- What is being tested?
- Daily Screen Media Exposure and Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)
- How many people
- 153 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2025to 1 May 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 12 to 42 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri City Hospital, Pediatric Outpatient Clinics
Kayseri, 38080
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Language Development, Screen Time, Child Development
- Being tested
- Daily Screen Media Exposure, Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)
- Keywords
- screen time, language development, Bayley-4, toddler, receptive language, expressive language, cross-sectional study, early childhood, parental attitude
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Screen Media ExposureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 "0-30 min/day screen exposure" | 0-30 minutes/day of screen exposure (n=41) - lowest exposure category; single Bayley-4 assessment. Receives: Other: Daily Screen Media Exposure; Diagnostic 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. Receives: Other: Daily Screen Media Exposure; Diagnostic 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. Receives: Other: Daily Screen Media Exposure; Diagnostic 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. Receives: Other: Daily Screen Media Exposure; Diagnostic Test: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment (single cross-sectional assessment)
Secondary outcomes (2)
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.
Measured: 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.
Measured: At enrollment (single cross-sectional assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start5 Aug 2025
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Language DevelopmentStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Agah Bahadır Öztürk,MD, Kayseri City Hospital
- Investigators
- Agah B ÖZTÜRK, MD, Principal investigator, Kayseri City Hospital, Kayseri, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731386
- Sponsor's protocol ID
- Etik C.D.No:561(Kayseri CH)
- Acronym
- Leave blank
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Bayley N, Aylward GP. Bayley Scales of Infant and Toddler Development, Fourth Edition: Technical Manual. Bloomington, MN: NCS Pearson; 2019.
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/
PubMed 31091057Gastaud 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.
PubMed 37352820McArthur 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.
PubMed 34031229Torras-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.
PubMed 25069554Brushe 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.
PubMed 38436942Madigan 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.
PubMed 32202633
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07731386
- Acronym / sponsor ID
- Leave blank / Etik C.D.No:561(Kayseri CH)
- Conditions
- Language Development, Screen Time, Child Development
- Keywords
- screen time, language development, Bayley-4, toddler, receptive language, expressive language, cross-sectional study, early childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 28 Jul 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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 "0-30 min/day screen exposure" | – | Other: Daily Screen Media Exposure, Diagnostic Test: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)0-30 minutes/day of screen exposure (n=41) - lowest exposure category; single Bayley-4 assessment. |
| Group 2 "30-60 min/day screen exposure" | – | 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. |
| Group 3 "60-120 min/day screen exposure" | – | 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. |
| Group 4 ">120 min/day screen exposure" | – | 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. |
Who may qualify
- Ages
- 12 to 42 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Confirmed diagnosis of a neurodevelopmental disorder
- Confirmed genetic disorder
- Confirmed metabolic disorder
- Confirmed chronic disease
- Non-Turkish-speaking household
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Screen Media ExposureCaregiver-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. | Other | 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" |
| Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-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. | Diagnostic test | 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" |
Primary outcome
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.
2 secondary outcomes
Bayley-4 Expressive Communication Scaled Score
Time frame: At enrollment (single cross-sectional assessment)
Bayley-4 Cognitive, Fine Motor, and Gross Motor Scaled Scores
Time frame: At enrollment (single cross-sectional assessment)
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 28 Jul 2026.
- Results publicationBayley N, Aylward GP. Bayley Scales of Infant and Toddler Development, Fourth Edition: Technical Manual. Bloomington, MN: NCS Pearson; 2019.
- Results publication: PubMed 31091057Guidelines 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/
- Results publication: PubMed 37352820Gastaud 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.
- Results publication: PubMed 34031229McArthur 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.
- Results publication: PubMed 25069554Torras-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.
- Results publication: PubMed 38436942Brushe 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.
- Results publication: PubMed 32202633Madigan 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.
- Individual participant dataSharing planned: 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.
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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.
Agah B ÖZTÜRK, MD principal investigator
Kayseri City Hospital, Kayseri, Türkiye
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 Language Development and Screen Time, run by Kayseri City Hospital 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 5 inclusion and 6 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 28 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?
Bayley-4 Receptive Communication Scaled Score (time frame: At enrollment (single cross-sectional assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07731386, which also lists 7 linked publications.
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 28 Jul 2026.