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OpenTrials
Completed

NCT Number: NCT07513636

EVALUATION of SCREEN TIME of BABIES

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.

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Key information

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Parental Education Intervention

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

EVALUATION of SCREEN TIME in 6-18 MONTH-OLD BABIES BASED ON MOTHER'S EDUCATIONAL STATUS: A RANDOMIZED CONTROLLED TRIAL

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 7, 2026
Registry last updated
Jun 3, 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.