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

Official title

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

Overview

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).

Interventions

• Behavioral Ultrasound-aided articulation therapy
  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 outcome measures

• 20-item probe list accuracy [Time frame: Week0, Week4, Week8, Week16]

Secondary outcome measures (5)

• Intelligibility in Context Scale (ICS): Traditional Chinese [Time frame: Week1, Week 8, Week 16]
• Percentage Consonants Correct (PCC) [Time frame: Week0, Week 16]
• PedsQL TM (Pediatric Quality of Life Inventory TM) [Time frame: Week 0, Week 8,Week 16]
• Strengths and Difficulties Questionnaire (SDQ) [Time frame: Week 0, Week 8, Week16]
• Parental Stress Scale (PSS) [Time frame: Week0, Week 8, Week 16]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

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

Publications

• Hitchcock ER, Swartz MT, Lopez M. Speech Sound Disorder and Visual Biofeedback Intervention: A Preliminary Investigation of Treatment Intensity. Semin Speech Lang. 2019 Mar;40(2):124-137. doi: 10.1055/s-0039-1677763. Epub 2019 Feb 22. PMID 30795023
• Morgan AT, Murray E, Liegeois FJ. Interventions for childhood apraxia of speech. Cochrane Database Syst Rev. 2018 May 30;5(5):CD006278. doi: 10.1002/14651858.CD006278.pub3. PMID 29845607
• Alighieri C, Van Lierde K, De Caesemaeker AS, Demuynck K, Bruneel L, D'haeseleer E, Bettens K. Is High-Intensity Speech Intervention Better? A Comparison of High-Intensity Intervention Versus Low-Intensity Intervention in Children With a Cleft Palate. J Speech Lang Hear Res. 2021 Sep 14;64(9):3398-3415. doi: 10.1044/2021_JSLHR-21-00189. Epub 2021 Aug 25. PMID 34433000
• Alighieri C, Van Lierde K, Cammu H, Vanoost L, Bettens K. The retrospective acceptability of high intensity versus low intensity speech intervention in children with a cleft palate: A qualitative study from the parents' point of view using the Theoretical Framework of Acceptability. Int J Lang Commun Disord. 2023 Mar;58(2):326-341. doi: 10.1111/1460-6984.12788. Epub 2022 Oct 3. PMID 36189983
• Allen MM. Intervention efficacy and intensity for children with speech sound disorder. J Speech Lang Hear Res. 2013 Jun;56(3):865-77. doi: 10.1044/1092-4388(2012/11-0076). Epub 2012 Dec 28. PMID 23275415
• Cleland J, Crampin L, Campbell L, Dokovova M. Protocol for SonoSpeech Cleft Pilot: a mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate. Pilot Feasibility Stud. 2022 Apr 27;8(1):93. doi: 10.1186/s40814-022-01051-x. PMID 35477444
• Sugden E, Lloyd S, Lam J, Cleland J. Systematic review of ultrasound visual biofeedback in intervention for speech sound disorders. Int J Lang Commun Disord. 2019 Sep;54(5):705-728. doi: 10.1111/1460-6984.12478. Epub 2019 Jun 10. PMID 31179581
• Gibson T, Lee SAS. Use of ultrasound visual feedback in speech intervention for children with cochlear implants. Clin Linguist Phon. 2021 May 4;35(5):438-457. doi: 10.1080/02699206.2020.1792996. Epub 2020 Jul 17. PMID 32677475

Identifiers

NCT: NCT06831396 · UW 23-522 · HKU/HA HKW IRB · Central IRB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗