EVALUATION of SCREEN TIME of BABIES

June 1, 2026 updated by: Makbule Neslişah Tan, Dokuz Eylul University

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
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.
Experimental: İntervention
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.
Other: Parental Education Intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dokuz Eylul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023/17-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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