- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07273370
Child Speech Data Collection
January 16, 2026 updated by: JeeHyun Suh
A Study on Child Speech Data Collection for a Diagnostic App Targeting Delayed Articulation in Children
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
931
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
-
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, South Korea, 13620
- Seoul National University Bundang Hospital
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-
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
korean(south)
Description
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
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 |
|---|---|
|
children
2~13 years of children
|
A Korean-based language/articulation development assessment that evaluates consonant accuracy, vowel accuracy, and other aspects by having the subject pronounce listed words.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
U-TAP
Time Frame: baseline
|
Urimal Test of Articulation and Phonology
|
baseline
|
|
hi-dongdong
Time Frame: Day 1
|
Newly developed language assessment tool
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 26, 2025
Primary Completion (Actual)
November 28, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
November 19, 2025
First Submitted That Met QC Criteria
November 27, 2025
First Posted (Estimated)
December 9, 2025
Study Record Updates
Last Update Posted (Actual)
January 20, 2026
Last Update Submitted That Met QC Criteria
January 16, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- B-2510-1000-306
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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