Exploratory Trial of the "HiDongDong" Language Rehabilitation App for Articulation Delay.

NCT07613268 | Not Yet Recruiting DMC

• 1 other identifier: E-2510-1003-301
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Speech Sound Disorder; Language Development Disorders; Phonological Disorder

Keywords

Phonological Delay; AI-based Therapy; Digital Therapeutic; Pediatric Speech Development; Application-Based Language Rehabilitation; Articulation Delay; Speech Sound Disorder; Language Development Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and post-intervention (4 weeks)

Other Outcomes (9)

• Receptive language score measured by SELSI

  Baseline and post-intervention (4 weeks)

• Receptive language score measured by PRES

  Baseline and post-intervention (4 weeks)

• Expressive language score measured by SELSI

  Baseline and post-intervention (4 weeks)

Study Arms (2)

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.

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.

Behavioral: Standard Care / Speech Therapist Intervention

Interventions

HiDongDong Intervention DEVICE

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.

HiDongDong Intervention

Standard Care / Speech Therapist Intervention BEHAVIORAL

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.

Standard Care / Speech Therapist Intervention

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National IT Industry Promotion Agency, Republic of Korea: collaborator
• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Speech Sound Disorder; Language Development Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Communication Disorders; Neurodevelopmental Disorders; Mental Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

SEJIN KWON, BHS

CONTACT

+82 10-2939-7143; RQ300@snubh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: * Outcome Assessors (individuals evaluating pre- and post-intervention articulation performance) * Participants and treating clinicians are aware of group assignment, but the evaluators conducting articulation assessments are blinded to the intervention group to reduce bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)