- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07248397
Utvikling og validering av et screeningverktøy for førskolebarn i alderen 1-6 år
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Preschool children from Taoyuan City, Taiwan.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Preschool Children
Children aged 1-6 years enrolled in preschools and nurseries in Taoyuan City. |
This is an observational study. No intervention or treatment is administered. Participants complete developmental assessments for research purposes only. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Motor Development Score
Tidsramme: 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
Tidsramme: Baseline
|
Cognitive score from CADAS, assessed manually through structured play evaluating reasoning, attention, and memory. |
Baseline
|
|
Language Development Score
Tidsramme: Baseline
|
Language score from CADAS, obtained from human-administered tasks testing receptive and expressive language. |
Baseline
|
|
Social-Emotional Development Score
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Chia-Ling Chen, Chang Gung Memorial Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 202401410B0
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .