ClinicalTrials.gg
RecruitingNCT06831396Updated Mar 10, 2026

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

An interventional study of Ultrasound-aided articulation therapy in Speech Sound Disorder, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Nov 2023, registered Feb 2025).
  • Started Nov 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Speech Sound Disorder

Keywords

  • Speech and Language
  • Children
  • Treatment
  • Ultrasound
03

In context

Speech Sound Disorder

46 studies on the registry are indexed under Speech Sound Disorder; 16 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 39 interventional studies indexed under Speech Sound Disorder.

Browse Speech Sound Disorder studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Immediate treatment group

    Ultrasound-aided articulation therapy

    Behavioral: Ultrasound-aided articulation therapy

  • No intervention
    Wait-list Control Group

    No treatment for 4 weeks, and later having the same ultrasound-aided articulation therapy as immediate treatment group

Interventions

  • BehavioralUltrasound-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.

06

What researchers measure

Primary outcomes

  1. 20-item probe list accuracy

    Perceptual accuracy on an individualized 20-item target sound probe spanning varying linguistic levels (single words to narrative), reported in percentage.

    Time frame: Week0, Week4, Week8, Week16

Secondary outcomes

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

    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.

    Time frame: Week1, Week 8, Week 16

  2. Percentage Consonants Correct (PCC)

    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.

    Time frame: Week0, Week 16

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

    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.

    Time frame: Week 0, Week 8,Week 16

  4. Strengths and Difficulties Questionnaire (SDQ)

    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.

    Time frame: Week 0, Week 8, Week16

  5. Parental Stress Scale (PSS)

    An 18-item parent self-report measure of stress associated with parenting (score range 18-90); higher scores indicate greater parenting stress.

    Time frame: Week0, Week 8, Week 16

07

Study locations

1 of 1 sites recruiting
  • Hong Kong Children's Hospital and Child Assessment Centre of The Duchess of Kent Children's Hospital
    Hong Kong, Hong Kong
    Recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 32677475 ↗
  • Marchant J, McAuliffe MJ, Huckabee ML. Treatment of articulatory impairment in a child with spastic dysarthria associated with cerebral palsy. Dev Neurorehabil. 2008 Jan-Mar;11(1):81-90. doi: 10.1080/17518420701622697. PubMed 17943504 ↗
  • Nordberg A, Miniscalco C, Lohmander A, Himmelmann K. Speech problems affect more than one in two children with cerebral palsy: Swedish population-based study. Acta Paediatr. 2013 Feb;102(2):161-6. doi: 10.1111/apa.12076. Epub 2012 Nov 27. PubMed 23186066 ↗
  • Hayden DA, Square PA. Motor Speech Treatment Hierarchy: a systems approach. Clin Commun Disord. 1994 Sep;4(3):162-74. PubMed 7994291 ↗
  • Pennington L, Roelant E, Thompson V, Robson S, Steen N, Miller N. Intensive dysarthria therapy for younger children with cerebral palsy. Dev Med Child Neurol. 2013 May;55(5):464-71. doi: 10.1111/dmcn.12098. Epub 2013 Feb 26. PubMed 23441834 ↗
  • Pennington L, Miller N, Robson S, Steen N. Intensive speech and language therapy for older children with cerebral palsy: a systems approach. Dev Med Child Neurol. 2010 Apr;52(4):337-44. doi: 10.1111/j.1469-8749.2009.03366.x. Epub 2009 Sep 16. PubMed 19758364 ↗
  • Fox CM, Boliek CA. Intensive voice treatment (LSVT LOUD) for children with spastic cerebral palsy and dysarthria. J Speech Lang Hear Res. 2012 Jun;55(3):930-45. doi: 10.1044/1092-4388(2011/10-0235). Epub 2012 Jan 9. PubMed 22232407 ↗
  • Morgan AT, Vogel AP. A Cochrane review of treatment for dysarthria following acquired brain injury in children and adolescents. Eur J Phys Rehabil Med. 2009 Jun;45(2):197-204. Epub 2009 Jan 21. PubMed 19156018 ↗
  • Pennington L, Parker NK, Kelly H, Miller N. Speech therapy for children with dysarthria acquired before three years of age. Cochrane Database Syst Rev. 2016 Jul 18;7(7):CD006937. doi: 10.1002/14651858.CD006937.pub3. PubMed 27428115 ↗
  • Michi K, Yamashita Y, Imai S, Suzuki N, Yoshida H. Role of visual feedback treatment for defective /s/ sounds in patients with cleft palate. J Speech Hear Res. 1993 Apr;36(2):277-85. doi: 10.1044/jshr.3602.277. PubMed 8487520 ↗
  • Lee AS, Law J, Gibbon FE. Electropalatography for articulation disorders associated with cleft palate. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD006854. doi: 10.1002/14651858.CD006854.pub2. PubMed 19588407 ↗
  • Alighieri C, Bettens K, Bruneel L, Perry J, Hens G, Van Lierde K. One Size Doesn't Fit All: A Pilot Study Toward Performance-Specific Speech Intervention in Children With a Cleft (Lip and) Palate. J Speech Lang Hear Res. 2022 Feb 9;65(2):469-486. doi: 10.1044/2021_JSLHR-21-00405. Epub 2022 Jan 12. PubMed 35021015 ↗
  • Bessell A, Sell D, Whiting P, Roulstone S, Albery L, Persson M, Verhoeven A, Burke M, Ness AR. Speech and language therapy interventions for children with cleft palate: a systematic review. Cleft Palate Craniofac J. 2013 Jan;50(1):e1-e17. doi: 10.1597/11-202. Epub 2012 Mar 20. PubMed 22433039 ↗
  • Lane H, Harding S, Wren Y. A systematic review of early speech interventions for children with cleft palate. Int J Lang Commun Disord. 2022 Jan;57(1):226-245. doi: 10.1111/1460-6984.12683. Epub 2021 Nov 12. PubMed 34767284 ↗
  • Yeung NC, Lau JT, Yu XN, Chu Y, Shing MM, Leung TF, Li CK, Fok TF, Mak WW. Psychometric properties of the Chinese version of the Pediatric Quality Of Life Inventory 4.0 Generic Core scales among pediatric cancer patients. Cancer Nurs. 2013 Nov-Dec;36(6):463-73. doi: 10.1097/NCC.0b013e31827028c8. PubMed 23059765 ↗
  • Lau JT, Yu XN, Chu Y, Shing MM, Wong EM, Leung TF, Li CK, Fok TF, Mak WW. Validation of the Chinese version of the Pediatric Quality of Life Inventory (PedsQL) Cancer Module. J Pediatr Psychol. 2010 Jan-Feb;35(1):99-109. doi: 10.1093/jpepsy/jsp035. Epub 2009 May 6. PubMed 19420227 ↗
  • Nicola K, Watter P. Health-related quality of life from the perspective of children with severe specific language impairment. Health Qual Life Outcomes. 2015 Aug 14;13:127. doi: 10.1186/s12955-015-0326-1. PubMed 26268357 ↗
  • Varni JW, Limbers CA, Burwinkle TM. Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jul 16;5:43. doi: 10.1186/1477-7525-5-43. PubMed 17634123 ↗
  • Schmitt LC, Paterno MV, Huang S. Validity and internal consistency of the international knee documentation committee subjective knee evaluation form in children and adolescents. Am J Sports Med. 2010 Dec;38(12):2443-7. doi: 10.1177/0363546510374873. Epub 2010 Aug 30. PubMed 20805408 ↗
  • Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003. PubMed 10024117 ↗
  • Gomersall T, Spencer S, Basarir H, Tsuchiya A, Clegg J, Sutton A, Dickinson K. Measuring quality of life in children with speech and language difficulties: a systematic review of existing approaches. Int J Lang Commun Disord. 2015 Jul;50(4):416-35. doi: 10.1111/1460-6984.12147. Epub 2015 Jan 29. PubMed 25630911 ↗
  • Markham C, Dean T. Parents' and professionals' perceptions of Quality of Life in children with speech and language difficulty. Int J Lang Commun Disord. 2006 Mar-Apr;41(2):189-212. doi: 10.1080/13682820500221485. PubMed 16546895 ↗
  • Feeney R, Desha L, Khan A, Ziviani J. Contribution of speech and language difficulties to health-related quality-of-life in Australian children: A longitudinal analysis. Int J Speech Lang Pathol. 2017 Apr;19(2):139-152. doi: 10.3109/17549507.2016.1151935. Epub 2016 Apr 4. PubMed 27063693 ↗
  • Lancaster HS, Lien KM, Chow JC, Frey JR, Scherer NJ, Kaiser AP. Early Speech and Language Development in Children With Nonsyndromic Cleft Lip and/or Palate: A Meta-Analysis. J Speech Lang Hear Res. 2019 Dec 13;63(1):14-31. doi: 10.1044/2019_JSLHR-19-00162. Print 2020 Jan 22. PubMed 31841365 ↗
  • Boyce JO, Kilpatrick N, Reilly S, Da Costa A, Morgan AT. Receptive and expressive language characteristics of school-aged children with non-syndromic cleft lip and/or palate. Int J Lang Commun Disord. 2018 Sep;53(5):959-968. doi: 10.1111/1460-6984.12406. Epub 2018 Jul 3. PubMed 29968398 ↗
  • Feragen KB, Saervold TK, Aukner R, Stock NM. Speech, Language, and Reading in 10-Year-Olds With Cleft: Associations With Teasing, Satisfaction With Speech, and Psychological Adjustment. Cleft Palate Craniofac J. 2017 Mar;54(2):153-165. doi: 10.1597/14-242. Epub 2015 Jun 29. PubMed 26120883 ↗
  • Klinto K, Salameh EK, Lohmander A. Verbal competence in narrative retelling in 5-year-olds with unilateral cleft lip and palate. Int J Lang Commun Disord. 2015 Jan-Feb;50(1):119-28. doi: 10.1111/1460-6984.12127. Epub 2014 Sep 11. PubMed 25208601 ↗
  • Chapman KL. The relationship between early reading skills and speech and language performance in young children with cleft lip and palate. Cleft Palate Craniofac J. 2011 May;48(3):301-11. doi: 10.1597/08-213. Epub 2010 Aug 17. PubMed 20815721 ↗
  • Collett BR, Leroux B, Speltz ML. Language and early reading among children with orofacial clefts. Cleft Palate Craniofac J. 2010 May;47(3):284-92. doi: 10.1597/08-172.1. PubMed 20426677 ↗
  • Flynn T, Moller C, Jonsson R, Lohmander A. The high prevalence of otitis media with effusion in children with cleft lip and palate as compared to children without clefts. Int J Pediatr Otorhinolaryngol. 2009 Oct;73(10):1441-6. doi: 10.1016/j.ijporl.2009.07.015. Epub 2009 Aug 25. PubMed 19709760 ↗
  • Sell D, Harding A, Grunwell P. GOS.SP.ASS.'98: an assessment for speech disorders associated with cleft palate and/or velopharyngeal dysfunction (revised). Int J Lang Commun Disord. 1999 Jan-Mar;34(1):17-33. doi: 10.1080/136828299247595. PubMed 10505144 ↗
  • John A, Sell D, Sweeney T, Harding-Bell A, Williams A. The cleft audit protocol for speech-augmented: A validated and reliable measure for auditing cleft speech. Cleft Palate Craniofac J. 2006 May;43(3):272-88. doi: 10.1597/04-141.1. PubMed 16681400 ↗
  • Taylor OD, Ware RS, Weir KA. Speech pathology services to children with cancer and nonmalignant hematological disorders. J Pediatr Oncol Nurs. 2012 Mar-Apr;29(2):98-108. doi: 10.1177/1043454212438963. PubMed 22472483 ↗
  • Simms MD. Language disorders in children: classification and clinical syndromes. Pediatr Clin North Am. 2007 Jun;54(3):437-67, v. doi: 10.1016/j.pcl.2007.02.014. PubMed 17543904 ↗
  • Snowling MJ, Bishop DV, Stothard SE, Chipchase B, Kaplan C. Psychosocial outcomes at 15 years of children with a preschool history of speech-language impairment. J Child Psychol Psychiatry. 2006 Aug;47(8):759-65. doi: 10.1111/j.1469-7610.2006.01631.x. PubMed 16898989 ↗

Individual participant data

Plan to share: No — The dataset contains sensitive information from a small number of pediatric participants, including speech recordings, video-derived accuracy scores, and clinical details, which could risk re-identification even after de-identification. Sharing is restricted under our institutional ethics approval.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Aug 2026, 33 months after the start.

Of 23 interventional studies with no phase under Speech Sound Disorder, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's planned 33 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2025
First posted
Feb 18, 2025
StartActual
Nov 11, 2023
Primary completionEst.
Aug 30, 2026
CompletionEst.
Oct 30, 2026
Last update
Mar 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06831396
Responsible party
Yiu Oi Yan (Principal Investigator, The University of Hong Kong) — Principal investigator
First posted
Feb 18, 2025
Start date
Nov 11, 2023
Primary completion
Aug 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Mar 10, 2026

Study contacts

Oi Yan Yoyo Yiu
Contact
h0501126@connect.hku.hk
5741 3431

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion