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NCT Number: NCT07248397

Development and Validation of a Screening Tool for Preschool Children Aged 1-6 Years

This study develops and validates the Chatbot-Assisted Developmental Assessment Scale for Preschool Children (CADAS), a screening tool for 1-6-year-olds. Using AI and the Kebbi Air S robot, CADAS assesses motor, cognitive, language, and social-emotional development through interactive games. A total of 180 children will participate, comparing AI-robot and human assessments for reliability and validity. The project aims to create a localized, efficient, and accurate developmental screening tool to support early detection and improve child development services in Taiwan.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Early Childhood Development (ECD)

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

Current developmental assessments in Taiwan rely mainly on foreign tools, which limit cultural suitability. This study addresses that gap by creating a local, AI-based screening system using Kebbi Air S, a social robot capable of voice prompts, facial recognition, and data recording. Five game-like scenarios will assess different developmental domains; one will be robot-assisted and four human-administered for comparison. 180 children (1-6 years) will be recruited from a nonprofit preschool in Taoyuan, with 60 also taking the Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT) for validation. Analyses using SPSS 21.0 and ConQuest 4.5 will test reliability, validity, and item quality. The study aims to build a reliable local tool and confirm the feasibility of chatbot-assisted evaluation, contributing to a national preschool development database and improving early intervention accuracy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children aged 1-6 years enrolled in preschools or nurseries in Taoyuan City.
  • Parent or guardian consent obtained.
  • Able to follow basic instructions and complete play-based tasks

Exclusion criteria

  • Diagnosed developmental, neurological, or genetic disorders.
  • Severe visual, hearing, or motor impairments affecting task performance.
  • No parental consent or early withdrawal during assessment.

Treatment and study plan

No Intervention: Observational Cohort

Other

This is an observational study. No intervention or treatment is administered. Participants complete developmental assessments for research purposes only.

Primary outcomes

  1. Motor Development Score

    Time frame: Baseline

    Motor score from CADAS, manually administered by trained research assistants to assess gross and fine motor skills through play-based tasks.

  2. Cognitive Development Score

    Time frame: Baseline

    Cognitive score from CADAS, assessed manually through structured play evaluating reasoning, attention, and memory.

  3. Language Development Score

    Time frame: Baseline

    Language score from CADAS, obtained from human-administered tasks testing receptive and expressive language.

  4. Social-Emotional Development Score

    Time frame: Baseline

    Social-emotional score from Scenario 3 using the Kebbi Air S robot. Robot-guided prompts and facial recognition are used to assess emotion and interaction, compared with manual ratings.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

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.

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