Early Childhood Development (ECD)NCT07248397
Development and Validation of a Screening Tool for Preschool Children Aged 1-6 Years
An observational study of Early Childhood Development (ECD), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Development (ECD)
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Sep 2024to 22 Sep 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preschool children from Taoyuan City, Taiwan.
Who may be able to join
- 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
Who cannot join
- Diagnosed developmental, neurological, or genetic disorders.
- Severe visual, hearing, or motor impairments affecting task performance.
- No parental consent or early withdrawal during assessment.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Early Childhood Development (ECD)
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Chatbot-Assisted Developmental Assessment Scale for Preschool Children (CADAS), preschool children, motor development, cognitive development, language development, social-emotional development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
This is an observational study. No intervention or treatment is administered. Participants complete developmental assessments for research purposes only.
| Study group | Role | What they receive |
|---|---|---|
| Preschool Children | Children aged 1-6 years enrolled in preschools and nurseries in Taoyuan City. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Development Score
Motor score from CADAS, manually administered by trained research assistants to assess gross and fine motor skills through play-based tasks.
Measured: Baseline
Cognitive Development Score
Cognitive score from CADAS, assessed manually through structured play evaluating reasoning, attention, and memory.
Measured: Baseline
Language Development Score
Language score from CADAS, obtained from human-administered tasks testing receptive and expressive language.
Measured: Baseline
Social-Emotional Development Score
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start23 Sep 2024
- Primary completion22 Sep 2027 (estimated)
- Study completion22 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood Development (ECD)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248397
- Sponsor's protocol ID
- 202401410B0
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Screening Tool for Preschool Children Aged 1-6 Years
- ClinicalTrials.gov ID
- NCT07248397
- Acronym / sponsor ID
- 202401410B0
- Conditions
- Early Childhood Development (ECD)
- Keywords
- Chatbot-Assisted Developmental Assessment Scale for Preschool Children (CADAS), preschool children, motor development, cognitive development, language development, social-emotional development
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 22 Sep 2027 (estimated)
- Study completion
- 22 Sep 2027 (estimated)
- First posted
- 25 Nov 2025 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preschool Children | – | Other: No Intervention: Observational CohortChildren aged 1-6 years enrolled in preschools and nurseries in Taoyuan City. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preschool children from Taoyuan City, Taiwan.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosed developmental, neurological, or genetic disorders.
- Severe visual, hearing, or motor impairments affecting task performance.
- No parental consent or early withdrawal during assessment.
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 |
|---|---|---|
| No Intervention: Observational CohortThis is an observational study. No intervention or treatment is administered. Participants complete developmental assessments for research purposes only. | Other | Preschool Children |
Primary outcome
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.
Cognitive Development Score
Time frame: Baseline
Cognitive score from CADAS, assessed manually through structured play evaluating reasoning, attention, and memory.
Language Development Score
Time frame: Baseline
Language score from CADAS, obtained from human-administered tasks testing receptive and expressive language.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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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.
Chia-Ling Chen study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Childhood Development (ECD), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Motor Development Score (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2025.