ChildrenNCT07273370
Child Speech Data Collection
An observational study of Children and Developmental Delays, run by JeeHyun Suh at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Developmental Delays
- What is being tested?
- U-TAP and hidongdong
- How many people
- 931 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Sep 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: korean(south)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: 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.
- Conditions
- Children, Developmental Delays
- Being tested
- U-TAP, hidongdong
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| children | 2~13 years of children Receives: Diagnostic Test: U-TAP; Diagnostic Test: hidongdong |
What is being measured
The primary outcome is the main question the study is designed to answer.
U-TAP
Urimal Test of Articulation and Phonology
Measured: baseline
hi-dongdong
Newly developed language assessment tool
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start26 Sep 2025
- Primary completion28 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 931 participants (actual)
Sponsor and investigators
- Lead sponsor
- JeeHyun Suh
- Sponsor type
- University, hospital or other
- Collaborators
- National IT Industry Promotion Agency, South Korea
- Responsible party
- Sponsor-investigator, JeeHyun Suh, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273370
- Sponsor's protocol ID
- B-2510-1000-306
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Child Speech Data Collection for a Diagnostic App Targeting Delayed Articulation in Children
- ClinicalTrials.gov ID
- NCT07273370
- Acronym / sponsor ID
- B-2510-1000-306
- Conditions
- Children, Developmental Delays
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 931 participants (actual)
- Lead sponsor
- JeeHyun SuhUniversity, hospital or other
- Collaborators
- National IT Industry Promotion Agency, South Korea
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 9 Dec 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children | – | Diagnostic Test: U-TAP, Diagnostic Test: hidongdong2~13 years of children |
Who may qualify
- Ages
- 2 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- korean(south)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| U-TAPA Korean-based language/articulation development assessment that evaluates consonant accuracy, vowel accuracy, and other aspects by having the subject pronounce listed words. | Diagnostic test | children |
| hidongdongThis 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. | Diagnostic test | children |
Primary outcome
U-TAP
Time frame: baseline
Urimal Test of Articulation and Phonology
hi-dongdong
Time frame: Day 1
Newly developed language assessment tool
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Children and Developmental Delays, run by JeeHyun Suh at 1 site in South Korea.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 20 Jan 2026. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
U-TAP (time frame: baseline). The study lists 2 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 20 Jan 2026.