Communication in Children With or Without Biomedical Conditions: Speech and Language Profile, Related Outcomes and Articulation Treatment With Ultrasound
| Registry | NCT06831396 |
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: double, treatment |
| Enrollment | 60 (Estimated) |
| Sponsor | The University of Hong Kong (Other) |
| Conditions | Speech Sound Disorder |
| Interventions | Ultrasound-aided articulation therapy (Behavioral) |
| Dates | start 2023-11-11, primary completion 2026-08-30 (estimated), completion 2026-10-30 (estimated), first posted 2025-02-18, last updated 2026-03-10 |
| Locations | 1 site in Hong Kong |
Related Papers Related Patents Related Grants Related Experts
All trials for Speech Sound Disorder All trials of Ultrasound-aided articulation therapy
-Summary
This prospective randomized controlled trial investigates the effect of ultrasound visual biofeedback as an adjunct to articulation therapy in children with speech sound disorders involving lingual targets. The intervention aims to facilitate acquisition of misarticulated sounds by providing real-time visualization of tongue movements. Participants are randomized 1:1 to immediate treatment or wait-list control, with stratification by disorder type, age, and gender where feasible. The wait-list control group continues usual care for 4 weeks before crossing over to receive the same intervention (ethical crossover design).
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Immediate treatment group | Experimental | Behavioral: Ultrasound-aided articulation therapy | Ultrasound-aided articulation therapy |
| Wait-list Control Group | No intervention | | No treatment for 4 weeks, and later having the same ultrasound-aided articulation therapy as immediate treatment group |
- Ultrasound-aided articulation therapy (Behavioral): The intervention under investigation is a motor-phonetic approach to articulation therapy, enhanced with ultrasound visual biofeedback (UVBF). The treatment group will receive the intervention immediately, while the waitlist control group will receive treatment after the initial group completes the study. This design allows for comparative outcome assessments between both groups, ensuring that all participants ultimately receive treatment.
+Outcome measures
Primary outcomes
- 20-item probe list accuracy [Week0, Week4, Week8, Week16]: Perceptual accuracy on an individualized 20-item target sound probe spanning varying linguistic levels (single words to narrative), reported in percentage.
Secondary outcomes
- Intelligibility in Context Scale (ICS): Traditional Chinese [Week1, Week 8, Week 16]: A 7-item parent-report measure of functional intelligibility across communication partners (parents, immediate family, extended family, friends, acquaintances, teachers, strangers), rated on a 5-point scale for each item (total averaged score 1-5); higher scores indicate better intelligibility.
- Percentage Consonants Correct (PCC) [Week0, Week 16]: Derived from standardized perceptual speech assessment (HKCAT), a standardized word-level articulation test. PCC was calculated as the number of consonants produced correctly divided by total consonants, expressed as a percentage.
- PedsQL TM (Pediatric Quality of Life Inventory TM) [Week 0, Week 8,Week 16]: A 23-item child self-report and parent-proxy measure of health-related quality of life across physical, emotional, social, and school functioning domains (score range 0-100); higher scores indicate better health-related quality of life.
- Strengths and Difficulties Questionnaire (SDQ) [Week 0, Week 8, Week16]: A 25-item parent-report behavioral screening tool assessing emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior (total difficulties score range 0-40); higher scores indicate more behavioral difficulties.
- Parental Stress Scale (PSS) [Week0, Week 8, Week 16]: An 18-item parent self-report measure of stress associated with parenting (score range 18-90); higher scores indicate greater parenting stress.
+Eligibility
Sex: All, ages: 5 Years to 12 Years
Inclusion Criteria:
* Primary diagnosis of speech sound disorder with errors on lingual target sounds
* Probe accuracy <70% on the primary target sound at baseline
* Cantonese as the first language
* Hearing thresholds ≤25 dB in at least one ear, with no hearing loss exceeding 50 dB in the other ear
* No syndromes or obvious dysmorphic features
* No language disorders associated with biomedical conditions (e.g., cerebral palsy, autism spectrum disorder)
* No oronasal fistula identified on oral examination or diagnosed velopharyngeal insufficiency
Exclusion Criteria:
* Presence of syndromes or dysmorphic features
* Language disorder associated with biomedical conditions (e.g., cerebral palsy, autism spectrum disorder)
* Hearing thresholds >25 dB in one ear and >50 dB in the other ear Planned surgical intervention during the study period
+Locations (1)
| Facility | City | Country | Status |
|---|
| Hong Kong Children's Hospital and Child Assessment Centre of The Duchess of Kent Children's Hospital | Hong Kong | Hong Kong | Recruiting |
+Publications
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