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

November 18, 2025 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

180

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

  • Taiwan
      • Taoyuan District, Taiwan, 333
        • Chang Gung Memorial Hospital

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

Sampling Method

Non-Probability Sample

Study Population

Preschool children from Taoyuan City, Taiwan.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Preschool Children
Children aged 1-6 years enrolled in preschools and nurseries in Taoyuan City.
Other: No Intervention: Observational Cohort
This is an observational study. No intervention or treatment is administered. Participants complete developmental assessments for research purposes only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
Cognitive Development Score
Time Frame: Baseline
Cognitive score from CADAS, assessed manually through structured play evaluating reasoning, attention, and memory.
Baseline
Language Development Score
Time Frame: Baseline
Language score from CADAS, obtained from human-administered tasks testing receptive and expressive language.
Baseline
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.
Baseline

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Director: Chia-Ling Chen, Chang Gung Memorial Hospital

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)

September 23, 2024

Primary Completion (Estimated)

September 22, 2027

Study Completion (Estimated)

September 22, 2027

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202401410B0

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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