Speech Sound DisorderNCT06831396
Effectiveness of Ultrasound-Aided Articulation Therapy for Children With Speech Sound Disorders
A study testing Ultrasound-aided articulation therapy in people with Speech Sound Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Speech Sound Disorder
- What is being tested?
- Ultrasound-aided articulation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Nov 2023to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Children's Hospital and Child Assessment Centre of The Duchess of Kent Children's Hospital
Hong Kong
Oi Yan Yoyo Yiu, Speech Therapist, +85257413431, h0501126@connect.hku.hk
About this study
Official title: Communication in Children With or Without Biomedical Conditions: Speech and Language Profile, Related Outcomes and Articulation Treatment With Ultrasound
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).
- Conditions
- Speech Sound Disorder
- Being tested
- Ultrasound-aided articulation therapy
- Keywords
- Speech and Language, Children, Treatment, Ultrasound
- Medical subject headings
- Speech Sound Disorder, Speech, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-aided articulation therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment group | Experimental | Ultrasound-aided articulation therapy Receives: Behavioral: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week0, Week4, Week8, Week16
Secondary outcomes (5)
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.
Measured: Week1, Week 8, Week 16
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.
Measured: Week0, Week 16
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.
Measured: Week 0, Week 8,Week 16
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.
Measured: Week 0, Week 8, Week16
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.
Measured: Week0, Week 8, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start11 Nov 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Speech Sound DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to either the treatment group (n=30) or the waitlist control group (n=30), and stratified to the groups by disorders, age and gender whenever possible. The treatment group will receive the intervention immediately, while the waitlist control group will not receive the treatment until the initial treatment group has completed the study. This design allows for a comparison of outcomes between the treatment and control groups, while also ensuring that all participants have the opportunity to receive the treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiu Oi Yan, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831396
- Sponsor's protocol ID
- UW 23-522
- Other IDs
- HKU/HA HKW IRB, Central IRB
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 30795023Morgan 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 29845607Alighieri 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 34433000Alighieri 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 36189983Allen 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 23275415Cleland 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 35477444Sugden 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 31179581Gibson 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 32677475Marchant 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 17943504Nordberg 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 23186066Hayden DA, Square PA. Motor Speech Treatment Hierarchy: a systems approach. Clin Commun Disord. 1994 Sep;4(3):162-74.
PubMed 7994291Pennington 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 23441834Pennington 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 19758364Fox 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 22232407Morgan 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication in Children With or Without Biomedical Conditions: Speech and Language Profile, Related Outcomes and Articulation Treatment With Ultrasound
- ClinicalTrials.gov ID
- NCT06831396
- Acronym / sponsor ID
- UW 23-522
- Conditions
- Speech Sound Disorder
- Keywords
- Speech and Language, Children, Treatment, Ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the treatment group (n=30) or the waitlist control group (n=30), and stratified to the groups by disorders, age and gender whenever possible. The treatment group will receive the intervention immediately, while the waitlist control group will not receive the treatment until the initial treatment group has completed the study. This design allows for a comparison of outcomes between the treatment and control groups, while also ensuring that all participants have the opportunity to receive the treatment.
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment group | Experimental | Behavioral: Ultrasound-aided articulation therapyUltrasound-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 |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-aided articulation therapyThe 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. | Behavioural | Immediate treatment group |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 30795023Hitchcock 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.
- Background: PubMed 29845607Morgan 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.
- Background: PubMed 34433000Alighieri 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.
- Background: PubMed 36189983Alighieri 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.
- Background: PubMed 23275415Allen 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.
- Background: PubMed 35477444Cleland 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.
- Background: PubMed 31179581Sugden 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.
- Background: PubMed 32677475Gibson 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.
- Background: PubMed 17943504Marchant 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.
- Background: PubMed 23186066Nordberg 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.
- Background: PubMed 7994291Hayden DA, Square PA. Motor Speech Treatment Hierarchy: a systems approach. Clin Commun Disord. 1994 Sep;4(3):162-74.
- Background: PubMed 23441834Pennington 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.
- 9Patients Profile Treated by Speech-language therapy Service, with Emphasis on Language in a Children's HospitalLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-aided articulation therapy in people with Speech Sound Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oi Yan Yoyo Yiu (5741 3431, h0501126@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20-item probe list accuracy (time frame: Week0, Week4, Week8, Week16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06831396, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.