NCT07273370

Brief Summary

Verify the non-inferiority of Korea's language development assessment U-TAP and the self-developed language development assessment 'Hi Dongdong', and verify the non-inferiority of speech-language pathologist-based assessment versus AI-based assessment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
931

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

November 19, 2025

Last Update Submit

January 16, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • U-TAP

    Urimal Test of Articulation and Phonology

    baseline

  • hi-dongdong

    Newly developed language assessment tool

    Day 1

Study Arms (1)

children

2\~13 years of children

Diagnostic Test: U-TAPDiagnostic Test: hidongdong

Interventions

U-TAPDIAGNOSTIC_TEST

A Korean-based language/articulation development assessment that evaluates consonant accuracy, vowel accuracy, and other aspects by having the subject pronounce listed words.

children
hidongdongDIAGNOSTIC_TEST

This is a Korean-based language/pronunciation development assessment newly developed using the Delphi methodology for digital transformation. It evaluates consonant accuracy, vowel accuracy, and other aspects by having subjects pronounce presented words.

children

Eligibility Criteria

Age2 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

korean(south)

You may qualify if:

  • Children aged 2 to under 14 years old
  • Children possessing cognitive abilities sufficient to understand basic instructions and follow simple directions
  • Cases where the child's guardian has received a thorough explanation of the research purpose, methods, personal information, and voice data processing policies, and has signed the research consent form
  • Individuals who understand and consent to the research purpose and survey methods
  • Individuals meeting all criteria listed in the above selection criteria

You may not qualify if:

  • Cases where guardian consent has not been secured
  • Cases where consent has not been obtained for the Personal Information and Voice Data Usage Agreement
  • Children unable to perform research tasks due to moderate or higher intellectual disability
  • Children with temporarily distorted voice characteristics due to acute illness (e.g., respiratory disease)
  • When the recording environment (maintaining concentration, prompting speech) cannot be secured

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 9, 2025

Study Start

September 26, 2025

Primary Completion

November 28, 2025

Study Completion

December 31, 2025

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations