An interventional study of HiDongDong Intervention and Standard Care / Speech Therapist Intervention in Speech Sound Disorder, Language Development Disorders and Phonological Disorder, sponsored by Seoul National University Bundang Hospital. Not yet recruiting at 1 site in South Korea. Open to participants aged 2 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Treatment
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.
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.
1. Study Methods
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)
2. 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:
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.
46 studies on the registry are indexed under Speech Sound Disorder; 16 are open to participants now.
This study's planned enrollment of 48 is above the median of 40 across 39 interventional studies indexed under Speech Sound Disorder.
Browse Speech Sound Disorder studies →Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
in addition to written informed consent from the caregiver
Exclusion Criteria:
Any one of the above exclusion criteria is sufficient for exclusion.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: HiDongDong Intervention
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.
Behavioral: Standard Care / Speech Therapist Intervention
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.
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.
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.
Time frame: Baseline and post-intervention (4 weeks)
Receptive language score measured by SELSI
Receptive language ability is assessed using the Sequenced Language Scale for Infants (SELSI). Higher scores indicate better receptive language comprehension ability.
Time frame: Baseline and post-intervention (4 weeks)
Receptive language score measured by PRES
Receptive language ability is assessed using the Preschool Receptive-Expressive Language Scale (PRES). Higher scores indicate better receptive language comprehension ability.
Time frame: Baseline and post-intervention (4 weeks)
Expressive language score measured by SELSI
Expressive language ability is assessed using the Sequenced Language Scale for Infants (SELSI). Higher scores indicate better expressive language ability.
Time frame: Baseline and post-intervention (4 weeks)
Expressive language score measured by PRES
Expressive language ability is assessed using the Preschool Receptive-Expressive Language Scale (PRES). Higher scores indicate better expressive language ability.
Time frame: Baseline and post-intervention (4 weeks)
Functional Independence (WeeFIM)
Total score (18-126 points) across 6 domains and 18 items assessing functional independence in daily living activities; higher scores indicate greater independence.
Time frame: Baseline and post-intervention (4 weeks)
Caregiver Satisfaction
Caregiver satisfaction assessed using a 5-point Likert scale; higher scores indicate greater satisfaction.
Time frame: Baseline and post-intervention( 4 weeks)
Caregiver Depression(Beck Depression Inventory)
Caregiver depression assessed using the Beck Depression Inventory (BDI); total score ranges from 0 to 63, with higher scores indicating more severe depressive symptoms.
Time frame: Baseline and post-intervention (4 weeks)
Caregiver Anxiety(Beck Anxiety Inventory)
Caregiver anxiety assessed using the Beck Anxiety Inventory (BAI); total score ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms.
Time frame: Baseline and post-intervention( 4 weeks)
Clinician Satisfaction
Clinician satisfaction assessed using a 5-point Likert scale (1-5); higher scores indicate greater satisfaction.
Time frame: Baseline and post-intervention( 4 weeks)
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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