Child Speech Data Collection | NCT07273370

Studies
Child Speech Data Collection

NCT07273370

Sponsor

JeeHyun Suh

Status

Completed

Last Update Posted

Jan 20, 2026Actual

Enrollment

931Actual

Phase

Not provided

Conditions

Children
Developmental Delays

Interventions

U-TAP
hidongdong

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 26, 2025Actual

Primary Completion Date

Nov 28, 2025Actual

Completion Date

Dec 31, 2025Actual

First Submitted Date

Nov 19, 2025

First Submission Date that Met QC Criteria

Nov 27, 2025

First Posted Date

Dec 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2026

Last Update Posted Date

Jan 20, 2026Actual

Name	Class
National IT Industry Promotion Agency, South Korea	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

931Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
children		2~13 years of children	Diagnostic Test: U-TAP Diagnostic Test: hidongdong

Interventions

Name	Type	Description	Arm Group Labels	Other Names
U-TAP	Diagnostic Test	A Korean-based language/articulation development assessment that evaluates consonant accuracy, vowel accuracy, and other aspects by having the subject pronounce listed words.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
U-TAP	Urimal Test of Articulation and Phonology	baseline
hi-dongdong	Newly developed language assessment tool	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
When any of the criteria listed in the above exclusion criteria apply

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

korean(south)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	13620	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided