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NCT Number: NCT06831396

Effectiveness of Ultrasound-Aided Articulation Therapy for Children With Speech Sound Disorders

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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Key information

Conditions

Speech Sound Disorder Behavior Communication Communication Disorders Language Mental Disorders Neurodevelopmental Disorders Speech Verbal Behavior

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Children's Hospital and Child Assessment Centre of The Duchess of Kent Children's Hospital

Hong Kong

Location status: Recruiting

Location contact

Oi Yan Yoyo Yiu, Speech Therapist

CONTACT

[email protected]

+85257413431

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 20-item probe list accuracy

    Time frame: 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

  1. Intelligibility in Context Scale (ICS): Traditional Chinese

    Time frame: 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.

  2. Percentage Consonants Correct (PCC)

    Time frame: 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.

  3. PedsQL TM (Pediatric Quality of Life Inventory TM)

    Time frame: 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.

  4. Strengths and Difficulties Questionnaire (SDQ)

    Time frame: 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.

  5. Parental Stress Scale (PSS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Oi Yan Yoyo Yiu

CONTACT

[email protected]

5741 3431

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Communication in Children With or Without Biomedical Conditions: Speech and Language Profile, Related Outcomes and Articulation Treatment With Ultrasound

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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