Speech Sound DisorderNCT07613268
Exploratory Trial of the "HiDongDong" Language Rehabilitation App for Articulation Delay.
A study testing HiDongDong Intervention in people with Speech Sound Disorder and Language Development Disorders, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effectiveness of the AI-based application "HiDongDong" in improving articulation development in children aged 2 to under 14 years with suspected articulation delays. Read more about this study
- Who is it for?
- Ages 2 to 13 years
- Conditions the study is for
- Speech Sound Disorder, Language Development Disorders, Phonological Disorder
- What is being tested?
- HiDongDong Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2026to Aug 2026
- Phase
- Interventional
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
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 years to under 14 years
- Persistent difficulties in speech sound production, or reduced speech intelligibility that interferes with communicative participation, resulting in limitations in social participation, academic performance, or daily activities
- Articulation developmental delay suspected based on U-TAP results, with articulation performance more than 1 standard deviation below the mean for the same age group (-1SD)
- Sufficient cognitive ability to follow simple instructions via a mobile device (tablet)
- For children under 7 years of age: a caregiver who has received sufficient explanation of the study purpose and procedures and has voluntarily provided written informed consent
- For children aged 7 years or older: voluntary assent from the child after sufficient explanation of the study purpose and procedures by the investigator,
- in addition to written informed consent from the caregiver
Who cannot join
- Caregiver or child does not consent to study participation, or withdraws consent during the study
- U-TAP results indicate articulation development within the normal range, with no suspicion of articulation developmental delay
- Difficulty understanding simple instructions or participating in assessments and training due to moderate or severe cognitive impairment, attention deficit, autism spectrum disorder, or similar conditions
- Significantly limited speech production due to neuromuscular or anatomical causes, including severe visual impairment or visual field deficits, hearing impairment, cleft palate structural abnormalities, or severe oral/facial muscle dysfunction, resulting in difficulty with articulation
- Inability to continue study participation due to acute illness or other conditions that may affect assessment or training during the study period, or unwillingness of the caregiver or child to continue participation
- Determination by the principal investigator that study participation may pose a risk to the safety or well-being of the child
- Any one of the above exclusion criteria is sufficient for exclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
JINJU LEE, MSc, +82-10-3377-5741, RQ317@snubh.org
About this study
Official title: A Prospective, Single-center, Randomized Controlled, Open-Label, Assessor-Blinded, Investigator-Initiated Exploratory Clinical Trial of the Application-Based Language Rehabilitation Program "HiDongDong" for Improving Language Development in Children Suspected of Articulation and Phonological Delay
The purpose of this study is to evaluate the effectiveness of the AI-based application "HiDongDong" in improving articulation development in children aged 2 to under 14 years with suspected articulation delays. The program provides individualized language training based on a personalized assessment of vulnerable speech sounds. This trial aims to determine whether the digital therapeutic solution can enhance articulation skills and inform future strategies for language rehabilitation in children.
Read the detailed description
This exploratory randomized controlled trial (RCT) evaluates the effectiveness of the AI-based application "HiDongDong" in improving articulation in children aged 2 to under 14 years with suspected articulation delays.
- Study Methods
- Screening and Enrollment Children suspected of articulation developmental delay will be assessed for eligibility according to predefined inclusion and exclusion criteria. Eligible participants will be enrolled, randomized, and scheduled for study visits.
- Visit 1 - Baseline Assessment At the first visit, a blinded assessor will collect demographic data (child's age, sex, and underlying medical conditions) and conduct a single baseline assessment, including the following:
- Language assessments: U-TAP (Urimal Test of Articulation and Phonology)
- SELSI (Sequenced Language Scale for Infants) or PRES (Preschool Receptive- Expressive Language Scale)
- Functional independence: WeeFIM (Functional Independence Measure for Children)
- Caregiver emotional status: Satisfaction (5-point Likert scale), depression (BDI; Beck Depression Inventory), anxiety (BAI; Beck Anxiety Inventory)
- Clinician satisfaction: 5-point Likert scale
- Post-Assessment Procedures Following baseline assessment, the control group will be discharged and return home. For the intervention group, a personalized language training program will be generated based on the results of the HiDongDong assessment.
- Training and Orientation Participants in the intervention group will receive instruction on how to use the HiDongDong language training program, along with guidance on the study procedures.
- Intervention Period The intervention group will complete the HiDongDong language training program at home under caregiver supervision for 4 weeks, 5 sessions per week, 20 minutes per session. Adherence will be monitored throughout the intervention period. The control group will receive language training provided by a speech-language pathologist.
- Visit 2 - Post-Intervention Assessment and Study Completion Four weeks after the intervention, both the control and intervention groups will undergo a single post-intervention assessment conducted by a blinded assessor. Upon completion of the assessment, follow-up will be concluded.
- Comparator and Randomization Participants will be randomized by an independent statistician affiliated with the Medical Research Collaborating Center of the Biomedical Research Institute at Seoul National University Bundang Hospital (SNUBH), using SAS version 9.4.
Assessor blinding will be applied. A blinded assessor (e.g., a hospital-based speech-language pathologist) will conduct all assessments without knowledge of each participant's group allocation, in an independent time and setting.
The sole difference between the two groups is the provider of the intervention:
- Control group: Language training delivered by a speech-language pathologist
- Intervention group: Language training delivered via the HiDongDong application (investigational medical device)
Participants will return after 4 weeks for post-intervention assessment by a blinded assessor, after which follow-up will be concluded.
To prevent interim analysis, assessment results will not be disclosed to any study personnel until the dataset is complete.
- Being tested
- HiDongDong Intervention, Standard Care / Speech Therapist Intervention
- Keywords
- Phonological Delay, AI-based Therapy, Digital Therapeutic, Pediatric Speech Development, Application-Based Language Rehabilitation, Articulation Delay, Speech Sound Disorder, Language Development Disorders
- Medical subject headings
- Speech Sound Disorder, Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiDongDong InterventionDevice
Participants will receive a 4-week individualized articulation training program delivered via the AI-based HiDongDong application. Training is conducted at home under caregiver monitoring, 5 sessions per week, 20 minutes per session. Exercises are tailored to each child's articulation needs based on baseline assessment using U-TAP and the study-specific word list. Adherence and engagement will be monitored.
Standard Care / Speech Therapist InterventionBehavioural
Participants will receive standard articulation training conducted by a certified speech-language therapist. Outcome assessments will be conducted at the same time points as the experimental group for comparison.
| Study group | Role | What they receive |
|---|---|---|
| HiDongDong Intervention | Experimental | Participants will receive a 4-week individualized articulation training program delivered via the AI-based HiDongDong application. Training will be conducted at home under caregiver monitoring, 5 sessions per week, 20 minutes per session. Adherence and engagement will be monitored. Pre- and post-intervention assessments will measure articulation accuracy, speech intelligibility, and overall language performance. Receives: Device: HiDongDong Intervention |
| Standard Care / Speech Therapist Intervention | Active comparator | Participants will receive standard articulation training conducted by a certified speech-language therapist. Outcome assessments will be conducted at the same time points as the experimental group for comparison. Receives: Behavioral: Standard Care / Speech Therapist Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consonant accuracy (%) and vowel accuracy (%) assessed via U-TAP
Korean Articulation and Phonology Assessment (U-TAP). Changes in articulation accuracy will be evaluated following the 4-week HiDongDong intervention compared to the control group. A blinded speech-language therapist will present picture stimuli, and children's consonant and vowel production will be analyzed at word and sentence levels to identify misarticulations and error patterns.
Measured: Baseline and post-intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startMay 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech Sound DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National IT Industry Promotion Agency, South Korea
- Responsible party
- Principal investigator, JeeHyun Suh, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613268
- Sponsor's protocol ID
- E-2510-1003-301
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during the study will not be shared, in order to protect the privacy of pediatric participants and in accordance with institutional policy.