Excessive Screen Exposure in InfancyNCT07513636
EVALUATION of SCREEN TIME of BABIES
A study testing Parental Education Intervention in people with Excessive Screen Exposure in Infancy and Parental Education and Infant Screen Use, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate whether educating mothers can reduce screen time in infants aged 6-18 months. Early exposure to screens has been associated with potential negative effects on child development, including language delay, attention problems, and cognitive difficulties. Read more about this study
- Who is it for?
- Ages 6 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Excessive Screen Exposure in Infancy, Parental Education and Infant Screen Use
- What is being tested?
- Parental Education Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 May 2023to 30 Nov 2024
- Phase
- Interventional
- 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 6 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mothers with infants aged 6-18 months
- Infants with any level of screen exposure
- Registered at participating Family Health Centers
- Mothers willing to participate and provide informed consent
Who cannot join
- Infants with known neurological or developmental disorders
- Infants with chronic diseases affecting development
- Mothers unable to participate in educational sessions
- Incomplete follow-up or withdrawal from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION of SCREEN TIME in 6-18 MONTH-OLD BABIES BASED ON MOTHER'S EDUCATIONAL STATUS: A RANDOMIZED CONTROLLED TRIAL
This study aims to evaluate whether educating mothers can reduce screen time in infants aged 6-18 months. Early exposure to screens has been associated with potential negative effects on child development, including language delay, attention problems, and cognitive difficulties. Therefore, reducing screen exposure during infancy is considered important.
The study is designed as an open-label, parallel-group randomized controlled trial. A total of 92 mother-infant pairs are planned to be included and randomly assigned to either an intervention group or a control group. Mothers in the intervention group will receive structured education based on recommendations from the American Academy of Pediatrics, including practical strategies to manage situations where screen use is commonly introduced (such as feeding or soothing the infant). Educational materials and follow-up guidance will also be provided. The control group will not receive any specific intervention.
Read more
Data on infants' screen exposure will be collected at baseline and at follow-up visits at 3 and 6 months using structured questionnaires. Sociodemographic characteristics will also be recorded.
The primary outcome of the study is the change in infants' screen time over the follow-up period. The findings are expected to provide evidence on whether parental education can be an effective strategy to reduce screen exposure in early childhood and support its integration into primary care practices.
- Being tested
- Parental Education Intervention
- Keywords
- Infant screen time, Screen exposure, Parental education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental Education InterventionOther
Mothers in this group receive structured education based on American Academy of Pediatrics recommendations on infant screen use. The intervention includes a 30-40 minute group-based session, practical strategies to reduce screen exposure, and informational brochures. Follow-up educational reinforcement is provided at 3 months
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants in this group do not receive any specific educational intervention regarding screen use. They continue with routine care, and data on infant screen exposure are collected at baseline, 3 months, and 6 months. |
| İntervention | Experimental | Mothers in this group receive structured education based on American Academy of Pediatrics recommendations on infant screen use. The intervention includes a 30-40 minute group-based session, practical strategies to reduce screen exposure, and informational brochures. Follow-up educational reinforcement is provided at 3 months. Receives: Other: Parental Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in infant screen time
The primary outcome is the change in infants' daily screen exposure time (minutes/day), assessed using parent-reported questionnaires at baseline, 3 months, and 6 months.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start24 May 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Excessive Screen Exposure in InfancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makbule Neslişah Tan, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513636
- Sponsor's protocol ID
- 2023/17-10
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1.Arumugam CT, Said MA, Nik Farid ND. Screen-based media and young children: Review and recommendations. Malays Fam Physician. 22 Temmuz 2021;16(2):7-13. 2.Christakis DA, Gilkerson J, Richards JA, et al.Audible television and decreased adult wordsinfant vocalizations, and conversational turns: apopulation-based study. Arch Pediatr Adolesc Med2009; 163: 554-558 3.Jolin EM, Weller RA. Television viewing and its impact on childhood behaviors. Curr Psychiatry Rep2011; 13: 122-128 4.Carson V, Kuzik N, Hunter S, et al. Systematic reviewof sedentary behavior and cognitive development inearly childhood. Prev Med 2015; 78: 115-122.. 5. Livingstone S, Cagiltay K, Ólafsson K. EU Kids Online II Dataset: A cross-national study of children's use of the Internet and its associated opportunities and risks. British Journal of Educational Technology. 13 Ağustos 2015;46. 6. Council on Communications and Media, Brown A. Media use by children younger than 2 years. Pediatrics. Kasım 2011;128(5):1040-5.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION of SCREEN TIME in 6-18 MONTH-OLD BABIES BASED ON MOTHER'S EDUCATIONAL STATUS: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07513636
- Acronym / sponsor ID
- 2023/17-10
- Keywords
- Infant screen time, Screen exposure, Parental education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 7 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 study aims to evaluate whether educating mothers can reduce screen time in infants aged 6-18 months. Early exposure to screens has been associated with potential negative effects on child development, including language delay, attention problems, and cognitive difficulties. Therefore, reducing screen exposure during infancy is considered important.
The study is designed as an open-label, parallel-group randomized controlled trial. A total of 92 mother-infant pairs are planned to be included and randomly assigned to either an intervention group or a control group. Mothers in the intervention group will receive structured education based on recommendations from the American Academy of Pediatrics, including practical strategies to manage situations where screen use is commonly introduced (such as feeding or soothing the infant). Educational materials and follow-up guidance will also be provided. The control group will not receive any specific intervention.
Data on infants' screen exposure will be collected at baseline and at follow-up visits at 3 and 6 months using structured questionnaires. Sociodemographic characteristics will also be recorded.
The primary outcome of the study is the change in infants' screen time over the follow-up period. The findings are expected to provide evidence on whether parental education can be an effective strategy to reduce screen exposure in early childhood and support its integration into primary care practices.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants in this group do not receive any specific educational intervention regarding screen use. They continue with routine care, and data on infant screen exposure are collected at baseline, 3 months, and 6 months. |
| İntervention | Experimental | Other: Parental Education InterventionMothers in this group receive structured education based on American Academy of Pediatrics recommendations on infant screen use. The intervention includes a 30-40 minute group-based session, practical strategies to reduce screen exposure, and informational brochures. Follow-up educational reinforcement is provided at 3 months. |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Mothers with infants aged 6-18 months
- Infants with any level of screen exposure
- Registered at participating Family Health Centers
- Mothers willing to participate and provide informed consent
Key exclusion criteria (4 listed)
- Infants with known neurological or developmental disorders
- Infants with chronic diseases affecting development
- Mothers unable to participate in educational sessions
- Incomplete follow-up or withdrawal from the study
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 |
|---|---|---|
| Parental Education InterventionMothers in this group receive structured education based on American Academy of Pediatrics recommendations on infant screen use. The intervention includes a 30-40 minute group-based session, practical strategies to reduce screen exposure, and informational brochures. Follow-up educational reinforcement is provided at 3 months | Other | İntervention |
Primary outcome
Change in infant screen time
Time frame: Baseline to 6 months
The primary outcome is the change in infants' daily screen exposure time (minutes/day), assessed using parent-reported questionnaires at baseline, 3 months, and 6 months.
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 3 Jun 2026.
- Background1.Arumugam CT, Said MA, Nik Farid ND. Screen-based media and young children: Review and recommendations. Malays Fam Physician. 22 Temmuz 2021;16(2):7-13. 2.Christakis DA, Gilkerson J, Richards JA, et al.Audible television and decreased adult wordsinfant vocalizations, and conversational turns: apopulation-based study. Arch Pediatr Adolesc Med2009; 163: 554-558 3.Jolin EM, Weller RA. Television viewing and its impact on childhood behaviors. Curr Psychiatry Rep2011; 13: 122-128 4.Carson V, Kuzik N, Hunter S, et al. Systematic reviewof sedentary behavior and cognitive development inearly childhood. Prev Med 2015; 78: 115-122.. 5. Livingstone S, Cagiltay K, Ólafsson K. EU Kids Online II Dataset: A cross-national study of children's use of the Internet and its associated opportunities and risks. British Journal of Educational Technology. 13 Ağustos 2015;46. 6. Council on Communications and Media, Brown A. Media use by children younger than 2 years. Pediatrics. Kasım 2011;128(5):1040-5.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental Education Intervention in people with Excessive Screen Exposure in Infancy and Parental Education and Infant Screen Use, run by Dokuz Eylul 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 3 Jun 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?
Change in infant screen time (time frame: Baseline to 6 months). 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 NCT07513636, which also lists 1 linked publication.
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 3 Jun 2026.