Cleft Palate +/- LipNCT07692061
Speech Intervention Frameworks in Cantonese-speaking Children and Adolescences With Cleft Palate +/- Lip
A study testing Non-linear based phonological speech intervention and Linear-based speech intervention in people with Cleft Palate +/- Lip, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Cleft Palate ± Lip (CP±L) is one of the most well-known congenital anomalies worldwide. Children and adolescences with CP±L are at high risk of developing speech and communication difficulties due to a range of cleft-related etiologies. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Cleft Palate +/- Lip
- What is being tested?
- Non-linear based phonological speech intervention and Linear-based speech intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Jul 2026to 31 Dec 2028
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (i) age of 4 to 17;
- (ii) primary repair of the cleft palate±lip done prior to 24 months old;
- (iii) presence of at least one CSCs type errors which must include non-oral CSCs and/or posterior CSCs;
- (iv) language proficiency in Cantonese.
Who cannot join
- (i) a cognitive impairment;
- (ii) a hearing impairment based on pure-tone audiometry;
- (iii) known diagnosis of language difficulties/disorders;
- (iv) and/or other medical conditions that would affect their abilities to participate in the speech tasks independently.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploring Speech Intervention Frameworks for Cantonese-speaking Children and Adolescents With Cleft Palate +/- Lip: A Randomized-Controlled Trial
Cleft Palate ± Lip (CP±L) is one of the most well-known congenital anomalies worldwide. Children and adolescences with CP±L are at high risk of developing speech and communication difficulties due to a range of cleft-related etiologies. Even with timely or early repair of the palate, children with CP±L may still experience cleft-related speech difficulties with a notable proportion of children having continuing velopharyngeal insufficiency (VPI). VPI refers to the presence of incomplete velopharyngeal closure during speech production. Non-articulation parameters of VPI include hypernasality, nasal airflow errors, and grimace, with hypernasality being the hallmark characteristic of VPI. Speech error patterns attributed to continuing VPI may involve what is termed as active compensatory articulatory gestures. For instance, children with cleft palate speech/VPI may have difficulty building up sufficient oral pressure to produce oral targets and may attempt to achieve closure at the level of the glottis resulting in replacement of oral pressure targets with glottal stops or fricatives. The loss of distinctive features and the ability to make meaningful contrasts potentially impacts on global outcomes such as speech understandability and acceptability adversely. In fact, there was still no sufficient evidence to support the efficacy of specific intervention approaches or techniques. Additionally, there are only very few studies that have systematically compared different intervention approaches. Consensus on the effectiveness of different approaches remains inconclusive.
It is of vital importance to implement evidence-based speech intervention to achieve the optimal speech and resonance outcomes. Historically, speech intervention approaches can be categorized into motor-phonetic (MP) (+/- principles of motor learning) and linguistic-phonological (LP). Motor-phonetic approaches attempt to modify the phonetic errors individually by explicit instruction of the articulatory movement and extensive amount of practice. Motor-phonetic approaches can be undertaken with or without the application of principles of motor learning, which emphasize intensive practice, optimal task difficulty, and variable practice conditions for better retention and generalization. However, the generalization effect was solely evident for the targeted individual phonemes. Increasingly, cleft palate speech/VPI speech disorder is being viewed as a phonological impairment rather than simply an articulation disorder. Linguistic-phonological approaches, on the other hand, refer to phonological rule-based interventions, which attributes the child's speech sound errors to a disordered internal phonological system. Such approaches, target multiple speech sounds or sound classes, and assumes that there would be generalization across phonemes according to their distinctive features. Examples of LP approaches include the minimal pair approach, maximal oppositions and treatment of the empty set, multiple oppositions and Metaphon. Current evidence has suggested that LP approach resulted in a more superior generalization effects in terms of the speech outcomes within the same class and the overall percentage of speech accuracy. Nevertheless, it is crucial to recognize that these LP approaches still predominantly regard speech as a linear sequence of segments and speech sound errors as a set of rules. Target selection tends to be focused on individual phonemic errors in the children's phonetic repertoire and selected specific phonemes for treatment.
In contrast, non-linear phonological (NLP) intervention seeks to capture the complexity of speech sounds organized in a hierarchical structure. It is common to observe a range of phonemes or even classes of phonemes being replaced with a single glottal stop or fricative in cleft palate speech. This results in an extensive collapse of meaningful contrasts in the individual's speech, impacting negatively on speech understandability. As such, target selection in cleft speech intervention would be a critical component for successful treatment outcomes. NLP intervention views a word as a multi-tiered structure and emphasizes the broader nature of the phonological system. With a holistic viewpoint of the speech sound system, the target selection and the treatment direction based on NLP framework would be different. Different research had investigated the use of non-linear phonology in speech intervention. Some of them had revealed the positive outcomes. It is believed that speech intervention guided by non-linear phonology framework would facilitate wider changes in the phonological system of children with cleft palate speech / VPI speech disorder, resulting in a more significant generalization effect and increased overall speech intelligibility. Therefore, the current study would like to investigate the effectiveness of different types speech intervention approaches in children and adolescences with CP±L.
Read the detailed description
Introduction of the study Cleft Palate with/without Lip (CP±L) Cleft Palate with or without Lip (CP±L) is one of the most well-known congenital anomalies worldwide. Epidemiological studies indicate that it affects approximately 1 in every 600 newborn babies, with rate of occurrences reported at 1.33 to 2.23 per 1000 live and stillbirths in the Chinese population. CP±L can present as syndromic or non-syndromic. Children with CP±L are at high risk of developing speech and communication difficulties due to a range of cleft-related etiologies. Some studies have also showed that children with CP±L may have language and literacy difficulties. Research showed that this group of children require speech-language intervention at different stages across their lifespan. Speech articulation, intelligibility, velopharyngeal competence and psychosocial states have been some of the recognized outcome measurements in this field.
Cleft Palate Speech/ Velopharyngeal Insufficiency Even with timely or early repair of the palate, children with CP+L may still experience cleft-related speech difficulties with a notable proportion of children having continuing velopharyngeal insufficiency (VPI). VPI refers to the presence of incomplete velopharyngeal closure during speech production. Non-articulation parameters of VPI include hypernasality, nasal airflow errors, and grimace, with hypernasality being the hallmark characteristic of VPI. Speech error patterns attributed to continuing VPI may involve what is termed as active compensatory articulatory gestures. For instance, children with cleft palate speech/VPI may have difficulty building up sufficient oral pressure to produce oral targets and may attempt to achieve closure at the level of the glottis resulting in replacement of oral pressure targets with glottal stops or fricatives. The loss of distinctive features and the ability to make meaningful contrasts potentially impacts on global outcomes such as speech understandability and acceptability adversely. Another possible articulation outcome of VPI is weak/nasalized consonants or complete replacement of oral pressure targets with their homorganic nasal counterparts e.g., /t/ replaced with /n/. Speech articulation outcomes unrelated to VPI also include lateralization errors and/or backing errors. A possible etiology of this is the presence of an oronasal fistula. In the latter context for instance, the child attempts to avoid the oronasal fistula by moving the tongue posterior to the fistula.
Direct Speech Intervention Current treatment approaches and the evidence In fact, treatment or treatment efficacy studies in cleft palate/VPI remain limited. A systematic review by Bessell et al. (2013) concluded that there was no sufficient evidence to support the efficacy of specific intervention approaches or techniques. There are only very few studies that have systematically compared different intervention approaches. Consensus on the effectiveness of different approaches remains inconclusive. The heterogeneity of the treatment approaches was also revealed by a subsequent exploratory study by Williams et al. (2021), which identified 49 distinct intervention methods reported by Speech Therapists in the UK, including strategies targeting very young children, such as complexity approaches, cued articulation, and cycles approaches. A more recent systematic review and meta-analysis by Sand et al (2021) also reiterated the low overall quality of evidence in treatment studies addressing cleft/VPI speech disorders, urging the need for interventions that consider the global benefits for clients. Treatment outcomes may include the overall speech intelligibility and communicative participation in everyday settings. With that said, a standardized outcome set is also advocated for future studies to enable a more holistic analysis of the treatment outcomes.
It is of vital importance to implement evidence-based speech intervention to achieve the optimal speech and resonance outcomes. Research has shown that active errors including lateralization, palatalization of fricatives and glottal articulation are habituated and active compensatory articulatory patterns that can be readjusted responsively by speech therapy intervention. On the contrary, passive errors, such as weak and/or nasalized consonants due to VPI, require surgical intervention. The use of glottal articulation may also reflect VPI and both surgical intervention and speech intervention are needed. Historically, speech intervention approaches can be categorized into motor-phonetic (MP) (+/- principles of motor learning) and linguistic-phonological (LP). Motor-phonetic approaches attempt to modify the phonetic errors individually by explicit instruction of the articulatory movement and extensive amount of practice. Motor-phonetic approaches can be undertaken with or without the application of principles of motor learning, which emphasize intensive practice, optimal task difficulty, and variable practice conditions for better retention and generalization. A case study by Hanley et al (2023) demonstrated that MP approach incorporating PML was found to be effective in improving the accuracy of both active and passive cleft speech errors in children with cleft palate. Generalization was also seen in untreated items after 8 weeks of face-to-face twice-weekly sessions. However, the necessity of conducting treatment on the passive cleft type errors remains questionable. Moreover, the generalization effect was solely evident for the targeted individual phonemes.
Increasingly, cleft palate speech/VPI speech disorder is being viewed as a phonological impairment rather than simply an articulation disorder. Howard et al. (2019) also stressed the phonological consequences of mechanical/structural constraints such as VPI in children with CP±L. Linguistic-phonological approaches, on the other hand, refer to phonological rule-based interventions, which attributes the child's speech sound errors to a disordered internal phonological system. Such approaches, target multiple speech sounds or sound classes, and assumes that there would be generalization across phonemes according to their distinctive features. Examples of LP approaches include the minimal pair approach, maximal oppositions and treatment of the empty set, multiple oppositions and Metaphon. A case study by Anderson et al (2024) employed the multiple oppositions approach to treat non-oral and passive CSCs. It revealed that the multiple oppositions intervention, as an LP approach, was found to be effective in improving the speech accuracy and intelligibility at conversational level, with sustained results also observed during the maintenance phase. The results suggested that the LP approach brought about a system-wide change of the phonological system in children with CP±L. Despite these findings, the limitations of small sample sizes in studies warrant caution in interpreting the generalizability of the results. Another randomized control trial with a larger sample size by Alighieri et al (2025) compared the effectiveness of MP and LP approaches (i.e. modified Metaphon approach). They found that while both MP and LP approaches could lead to generalization, LP approach resulted in a more superior generalization effects in terms of the speech outcomes within the same class and the overall percentage of speech accuracy. Nevertheless, it is crucial to recognize that these LP approaches still predominantly regard speech as a linear sequence of segments and speech sound errors as a set of rules. Target selection tends to be focused on individual phonemic errors in the children's phonetic repertoire and selected specific phonemes for treatment.
An Alternative Treatment Framework Application of non-linear phonology Phonological intervention approaches described above are often implemented under a linear paradigm, focusing on isolated phonemes. In contrast, non-linear phonological intervention, developed by Bernhardt and Stemberger (1994), seeks to capture the complexity of speech sounds organized in a hierarchical structure. It is common to observe a range of phonemes or even classes of phonemes being replaced with a single glottal stop or fricative in cleft palate speech. This consequently results in an extensive/ significant collapse of meaningful contrasts in the individual's speech, thereby VPI impacting negatively on speech understandability. As such, the premise of speech intervention would be to maximize overall understandability, acceptability and intelligibility. Target selection in cleft speech intervention would, therefore, be a critical component for successful treatment outcomes. Non-linear phonological intervention views a word as a multi-tiered structure. It emphasizes the broader nature of the phonological system and it believes that the system is more complex than speech sounds alon. With a holistic viewpoint of the speech sound system, the target selection and the treatment direction based on non-linear phonological framework would be different. Different research had investigated the use of non-linear phonology in speech intervention. Some of them had revealed the positive outcomes. It is believed that speech intervention guided by non-linear phonology framework would facilitate wider changes in the phonological system of children with cleft palate speech / VPI speech disorder. Subsequently, a more significant generalization effect across sound classes would be expected so that the overall speech intelligibility would be maximized. Yet, the application of non-linear phonology in the field of cleft/VPI population is yet to be adopted widely.
Research Questions
Indeed, SLPs reported a high degree of variability in selecting treatment approaches in their practice for children with CP±L. Such discrepancies may also be attributed to the lack of consensus in target selection and subsequent treatment directions. In view of this, the present study aims to conduct a randomized controlled trial to investigate the effectiveness of non-linear phonological intervention approach in improving speech outcomes in Cantonese-speaking children with CP±L and compare the effectiveness of LP approaches based on linear and non-linear phonology. The study will also further examine the phonological skills and functional impact on the individuals with CP±L after speech intervention. The followings are the proposed research questions:
(i) Is non-linear phonological intervention effective in improving speech outcomes in Cantonese-speaking children and adolescences with CP±L? Ho: Non-linear phonological intervention has no effect on improving speech outcomes in Cantonese-speaking children and adolescences with CP±L.
H1: Non-linear phonological intervention is effective in improving speech outcomes in Cantonese-speaking children and adolescences with CP±L.
(ii) Is a speech intervention approach based on non-linear phonological framework more effective in improving speech outcomes than the one based on linear phonology in Cantonese-speaking children and adolescences with CP±L? Ho: A speech intervention approach based on a non-linear phonological framework is not more effective in improving speech outcomes than one based on linear phonology in Cantonese-speaking children and adolescences with CP±L.
H1: A speech intervention approach based on a non-linear phonological framework is more effective in improving speech outcomes than one based on linear phonology in Cantonese-speaking children and adolescences with CP±L.
(iii) Are the phonological skills improved after phonological intervention in both groups? Ho: Phonological skills do not show significant improvement after phonological intervention in both groups of participants.
H1: Phonological skills show significant improvement after phonological intervention in both groups of participants.
(iv) Are the patient-reported outcomes also improved with the speech outcomes followed by the treatment? Ho: The patient-reported outcomes are not improved with the enhanced articulatory accuracy after treatment.
H1: The patient-reported outcomes are improved with the enhanced articulatory accuracy after treatment.
- Conditions
- Cleft Palate +/- Lip
- Being tested
- Non-linear based phonological speech intervention, Linear-based speech intervention
- Keywords
- cleft palate, cleft lip and palate, cleft lip, non-linear phonology, phonological intervention, speech Intervention
- Medical subject headings
- Cleft Palate, Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-linear based phonological speech interventionBehavioural
Traditionally, phonological speech intervention approaches (including the ones with children with cleft lip and palate) are often implemented under a linear paradigm, focusing on isolated phonemes. Non-linear phonological intervention, developed by Bernhardt and Stemberger (1994), seeks to capture the complexity of speech sounds organized in a hierarchical structure. It views a word as a multi-tiered structure and emphasizes the broader nature of the phonological system and it believes that the system is more complex than speech sounds alone. With a holistic viewpoint of the speech sound system, the target selection and the treatment direction based on non-linear phonological framework would be different. The premise of speech intervention would be to maximize overall understandability, acceptability and intelligibility. Target selection in cleft speech intervention would, therefore, be a critical component for successful treatment outcomes.
Linear-based speech interventionBehavioural
Linear-based phonological approaches refer to speech interventions that target multiple phonemes according to the child's production of speech errors. Such approaches assume that there would be generalization across phonemes according to their distinctive features. Examples of linear-based approaches include the minimal pair approach, maximal oppositions and treatment of the empty set, multiple oppositions and Metaphon.
| Study group | Role | What they receive |
|---|---|---|
| Non-linear based phonological (NLP) intervention group | Experimental | Not described Receives: Behavioral: Non-linear based phonological speech intervention |
| Linear based phonological (LP) intervention group | Active comparator | Not described Receives: Behavioral: Linear-based speech intervention |
| Waitlist control group | No intervention | They will receive intervention after the study phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceputal Assessment of Cleft Speech - Cantonese: Understandability
A scale measuring how understandable the speech is. 0 = Within normal limits - Speech is always easy to understand; 3 = Severe - Speech is hard to understand most or all of the time
Measured: One week before the intervention, one week, one month and three months after the intervention
Perceptual Assessment of Cleft Speech - Cantonese: Acceptability
A scale that measures how acceptable the speech is. 0 = Within normal limits - Speech is normal ; 3 = Severe - Speech deviates from normal to a severe degree
Measured: One week before the intervention, one week, one month and three months after the intervention
Perceptual Assessment of Cleft Speech - Cantonese: Hypernasality
A scale that measures how hypernasal the speech is. 0 = Within normal limits; 3 = Severe - Increased nasality heard on high and low vowels while some lose their identity
Measured: One week before the intervention, one week, one month and three months after the intervention
Perceptual Assessment of Cleft Speech - Cantonese: Hyponasality
A scale that measures how hyponasal the speech is. 0 = Within normal limits/None; 1 = Present
Measured: One week before the intervention, one week, one month and three months after the intervention
Perceptual Assessment of Cleft Speech - Cantonese: Audible nasal emission
A scale that measures whether audible nasal emission is present. 0 = Absent; 2 = Frequently heard, > 5 instances out of 50 high pressure consonants
Measured: One week before the intervention, one week, one month and three months after the intervention
Perceptual Assessment of Cleft Speech - Cantonese: Nasal turbulence
A scale that measures whether nasal turbulence is present. 0 = Absent; 2 = Frequently heard, > 5 instances out of 50 high pressure consonants
Measured: One week before the intervention, one week, one month and three months after the intervention
Perceptual Assessment of Cleft Speech - Cantonese: Cleft speech errors
Transcription of speech errors during the speech test. There are in total 4 types of cleft speech characteristics: (1) Anterior Oral; (2) Posterior Oral; (3) Non-Oral; and (4) Passive
Measured: One week before the intervention, one week, one month and three months after the intervention
Focus on the Outcomes of Communication Under Six" (Traditional Chinese - Hong Kong version) (FOCUS©-TC HK)
FOCUS©-TC HK measures communicative participation. It evaluates how effectively a child uses communication to interact, play, and participate in everyday real-world activities at home, at school, and in the community.
FOCUS©-TC HK is a questionnaire (usually 50 items) completed by parents or caregivers, who rate the child's communication behaviors on a 7-point scale.
A higher Total Score indicates better communicative participation (max = 350 scores)
A lower Total Score indicates that the child's speech or language difficulties are significantly impacting their daily social interactions and quality of life (min = 50 scores)
Measured: One week before the intervention, one week, one month and three months after the intervention
CLEFT-Q - Speech Function scale score
The CLEFT-Q is a scientifically validated questionnaire used worldwide by doctors and speech therapists. The CLEFT-Q is a Patient-Reported Outcome Measure (PROM)-meaning it asks the child or young adult directly how they feel about their own life, appearance, and speech. This scale measures how the child perceives the physical clarity and mechanics of their own speech.
In standard CLEFT-Q scoring, the raw answers are converted into a score from 0 to 100. For all CLEFT-Q scales, a higher score always indicates a better outcome (i.e., better function or better quality of life).
Measured: One week before the intervention, one week, one month and three months after the intervention
CLEFT-Q - Speech Distress Scale Score
The CLEFT-Q is a scientifically validated questionnaire used worldwide by doctors and speech therapists. The CLEFT-Q is a Patient-Reported Outcome Measure (PROM)-meaning it asks the child or young adult directly how they feel about their own life, appearance, and speech. This scale measures the emotional burden and negative feelings caused by their speech difficulties.
In standard CLEFT-Q scoring, the raw answers are converted into a score from 0 to 100. For all CLEFT-Q scales, a higher score always indicates a better outcome (i.e., better function or better quality of life).
Measured: One week before the intervention, one week, one month and three months after the intervention
CLEFT-Q - Psychological Scale Score
The CLEFT-Q is a scientifically validated questionnaire used worldwide by doctors and speech therapists. The CLEFT-Q is a Patient-Reported Outcome Measure (PROM)-meaning it asks the child or young adult directly how they feel about their own life, appearance, and speech. This scale looks at the child's overall emotional well-being and self-esteem.
In standard CLEFT-Q scoring, the raw answers are converted into a score from 0 to 100. For all CLEFT-Q scales, a higher score always indicates a better outcome (i.e., better function or better quality of life).
Measured: One week before the intervention, one week, one month and three months after the intervention
Percentage correct consonants-revised (PCC-R)
It calculates how many consonants the child pronounced correctly out of the total number of consonants they attempted. The "Revised" (R) version counts distortions (like a slight lisp or mild nasal emission) as "correct," and only penalizes major errors like completely omitting a sound or substituting it with a completely different sound.
100% = perfectly correct production. Lower scores (e.g., < 50%) = Indicates a severe speech sound disorder where the child is dropping many sounds or swapping them out entirely, making them very hard to understand.
Measured: One week before the intervention, one week, one month and three months after the intervention
Percentage Correct Places (PCP)
It evaluates if the child is making the sound in the correct place of articulation (e.g., using their lips for "p" or "m", or the back of their tongue for "k" or "g"), regardless of whether the airflow or voicing was perfectly correct.
100% = perfectly correct production. Lower scores (e.g., < 50%) = Indicates a severe speech sound disorder where the child is making the sounds with a wrong place of articulation.
Measured: One week before the intervention, one week, one month and three months after the intervention
Percentage Correct Manners (PCM)
It evaluates if the child is using the correct manner of articulation (e.g., making a "stop" sound where air bursts out, a "fricative" where air hisses, or a "nasal" where air goes through the nose).
100% = perfectly correct production. Lower scores (e.g., < 50%) = Indicates a severe speech sound disorder where the child is making the sounds with a wrong manner of articulation.
Measured: One week before the intervention, one week, one month and three months after the intervention
Intelligibility in Context Scale - Traditional Chinese version (ICS-TC)
The ICS is a 7-item questionnaire that asks parents to rate how well different groups of people (ranging from immediate family members to complete strangers) understand their child's speech. Each of the 7 questions is rated on a 5-point scale (from 1 = "Never" to 5 = "Always").
The total score will be converted to an average score.
A higher score indicates excellent speech intelligibility. It means the child's speech is easily and consistently understood by everyone, regardless of whether they are talking to their parents, teachers, or strangers. (max = 5)
A lower score indicates severe intelligibility issues. It means that almost no one can understand what the child is saying in daily situations. (min = 1)
Measured: One week before the intervention, one week, one month and three months after the intervention
Secondary outcomes (1)
Percent scores of the informal tasks on phonological awareness
We would use a number of informal tests to evaluate the phonological awareness of the partipants. The test would be extracted from previous literature. The total score will be converted into percentage score in which a higher score will indicate a better phonological awareness. (Max = 100%; Min = 0%).
Measured: One week before the intervention, one week, one month and three months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start24 Jul 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Cleft Palate +/- LipStudies of the same condition, open and under way.
- More trials run by Chinese 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Ho Yin, Chinese University of Hong Kong
- Investigators
- Choco Ho Yin Ho, PhD Candidate, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692061
- Sponsor's protocol ID
- NTEC-2026-150
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong FW, King NM. A review of the rate of occurrence of cleft lip and palate in Chinese people. Hong Kong Med J. 1997 Mar;3(1):96-100.
PubMed 11847362Williams C, Harding S, Wren Y. An Exploratory Study of Speech and Language Therapy Intervention for Children Born With Cleft Palate +/- Lip. Cleft Palate Craniofac J. 2021 Apr;58(4):455-469. doi: 10.1177/1055665620954734. Epub 2020 Sep 18.
PubMed 32945191Andersen HS, Jorgensen LD, Wilstrup C, Willadsen E. Multiple oppositions intervention: effective phonological treatment of two children with cleft lip and palate and severe speech sound disorder. Clin Linguist Phon. 2025 Jan;39(1):57-78. doi: 10.1080/02699206.2024.2339308. Epub 2024 May 21.
PubMed 38770980Wakumoto M, Isaacson KG, Friel S, Suzuki N, Gibbon F, Nixon F, Hardcastle WJ, Michi K. Preliminary study of articulatory reorganisation of fricative consonants following osteotomy. Folia Phoniatr Logop. 1996;48(6):275-89. doi: 10.1159/000266422.
PubMed 8958664Tsangaris E, Wong Riff KWY, Goodacre T, Forrest CR, Dreise M, Sykes J, de Chalain T, Harman K, O'Mahony A, Pusic AL, Thabane L, Thoma A, Klassen AF. Establishing Content Validity of the CLEFT-Q: A New Patient-reported Outcome Instrument for Cleft Lip/Palate. Plast Reconstr Surg Glob Open. 2017 Apr 25;5(4):e1305. doi: 10.1097/GOX.0000000000001305. eCollection 2017 Apr.
PubMed 28507866Skelton SL. Concurrent task sequencing in single-phoneme phonologic treatment and generalization. J Commun Disord. 2004 Mar-Apr;37(2):131-55. doi: 10.1016/j.jcomdis.2003.08.002.
PubMed 15013730Shriberg LD, Austin D, Lewis BA, McSweeny JL, Wilson DL. The percentage of consonants correct (PCC) metric: extensions and reliability data. J Speech Lang Hear Res. 1997 Aug;40(4):708-22. doi: 10.1044/jslhr.4004.708.
PubMed 9263938Sell D, Mildinhall S, Albery L, Wills AK, Sandy JR, Ness AR. The Cleft Care UK study. Part 4: perceptual speech outcomes. Orthod Craniofac Res. 2015 Nov;18 Suppl 2(Suppl 2):36-46. doi: 10.1111/ocr.12112.
PubMed 26567854Sell 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 10505144Sell D, Sweeney T. Percent Consonant Correct as an Outcome Measure for Cleft Speech in an Intervention Study. Folia Phoniatr Logop. 2020;72(2):143-151. doi: 10.1159/000501095. Epub 2019 Jul 15.
PubMed 31307050Preston JL, McCabe P, Rivera-Campos A, Whittle JL, Landry E, Maas E. Ultrasound visual feedback treatment and practice variability for residual speech sound errors. J Speech Lang Hear Res. 2014 Dec;57(6):2102-15. doi: 10.1044/2014_JSLHR-S-14-0031.
PubMed 25087938Pereira VJ, So JYT, Tsang JMK, Choi WS, Tong MCF, Lee KYS. Speech Telepractice and Treatment Intensity in a Cantonese-Speaking Case with 22q11.2 Deletion Syndrome Following Late Diagnosis and Management of Velopharyngeal Dysfunction. Cleft Palate Craniofac J. 2023 Nov;60(11):1505-1512. doi: 10.1177/10556656221106042. Epub 2022 Jun 9.
PubMed 35678611Pereira VJ, Sell D. How differences in anatomy and physiology and other aetiology affect the way we label and describe speech in individuals with cleft lip and palate. Int J Lang Commun Disord. 2024 Nov-Dec;59(6):2181-2196. doi: 10.1111/1460-6984.12946. Epub 2023 Aug 31.
PubMed 37650488Pamplona MC, Ysunza A, Ramirez P. Naturalistic intervention in cleft palate children. Int J Pediatr Otorhinolaryngol. 2004 Jan;68(1):75-81. doi: 10.1016/j.ijporl.2003.09.007.
PubMed 14687690Pamplona MC, Ysunza A, Espinosa J. A comparative trial of two modalities of speech intervention for compensatory articulation in cleft palate children, phonologic approach versus articulatory approach. Int J Pediatr Otorhinolaryngol. 1999 Jun 15;49(1):21-6. doi: 10.1016/s0165-5876(99)00040-3.
PubMed 10428402
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Speech Intervention Frameworks for Cantonese-speaking Children and Adolescents With Cleft Palate +/- Lip: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT07692061
- Acronym / sponsor ID
- NTEC-2026-150
- Conditions
- Cleft Palate +/- Lip
- Keywords
- cleft palate, cleft lip and palate, cleft lip, non-linear phonology, phonological intervention, speech Intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 24 Jul 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jul 2026 (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.
Cleft Palate ± Lip (CP±L) is one of the most well-known congenital anomalies worldwide. Children and adolescences with CP±L are at high risk of developing speech and communication difficulties due to a range of cleft-related etiologies. Even with timely or early repair of the palate, children with CP±L may still experience cleft-related speech difficulties with a notable proportion of children having continuing velopharyngeal insufficiency (VPI). VPI refers to the presence of incomplete velopharyngeal closure during speech production. Non-articulation parameters of VPI include hypernasality, nasal airflow errors, and grimace, with hypernasality being the hallmark characteristic of VPI. Speech error patterns attributed to continuing VPI may involve what is termed as active compensatory articulatory gestures. For instance, children with cleft palate speech/VPI may have difficulty building up sufficient oral pressure to produce oral targets and may attempt to achieve closure at the level of the glottis resulting in replacement of oral pressure targets with glottal stops or fricatives. The loss of distinctive features and the ability to make meaningful contrasts potentially impacts on global outcomes such as speech understandability and acceptability adversely. In fact, there was still no sufficient evidence to support the efficacy of specific intervention approaches or techniques. Additionally, there are only very few studies that have systematically compared different intervention approaches. Consensus on the effectiveness of different approaches remains inconclusive.
It is of vital importance to implement evidence-based speech intervention to achieve the optimal speech and resonance outcomes. Historically, speech intervention approaches can be categorized into motor-phonetic (MP) (+/- principles of motor learning) and linguistic-phonological (LP). Motor-phonetic approaches attempt to modify the phonetic errors individually by explicit instruction of the articulatory movement and extensive amount of practice. Motor-phonetic approaches can be undertaken with or without the application of principles of motor learning, which emphasize intensive practice, optimal task difficulty, and variable practice conditions for better retention and generalization. However, the generalization effect was solely evident for the targeted individual phonemes. Increasingly, cleft palate speech/VPI speech disorder is being viewed as a phonological impairment rather than simply an articulation disorder. Linguistic-phonological approaches, on the other hand, refer to phonological rule-based interventions, which attributes the child's speech sound errors to a disordered internal phonological system. Such approaches, target multiple speech sounds or sound classes, and assumes that there would be generalization across phonemes according to their distinctive features. Examples of LP approaches include the minimal pair approach, maximal oppositions and treatment of the empty set, multiple oppositions and Metaphon. Current evidence has suggested that LP approach resulted in a more superior generalization effects in terms of the speech outcomes within the same class and the overall percentage of speech accuracy. Nevertheless, it is crucial to recognize that these LP approaches still predominantly regard speech as a linear sequence of segments and speech sound errors as a set of rules. Target selection tends to be focused on individual phonemic errors in the children's phonetic repertoire and selected specific phonemes for treatment.
In contrast, non-linear phonological (NLP) intervention seeks to capture the complexity of speech sounds organized in a hierarchical structure. It is common to observe a range of phonemes or even classes of phonemes being replaced with a single glottal stop or fricative in cleft palate speech. This results in an extensive collapse of meaningful contrasts in the individual's speech, impacting negatively on speech understandability. As such, target selection in cleft speech intervention would be a critical component for successful treatment outcomes. NLP intervention views a word as a multi-tiered structure and emphasizes the broader nature of the phonological system. With a holistic viewpoint of the speech sound system, the target selection and the treatment direction based on NLP framework would be different. Different research had investigated the use of non-linear phonology in speech intervention. Some of them had revealed the positive outcomes. It is believed that speech intervention guided by non-linear phonology framework would facilitate wider changes in the phonological system of children with cleft palate speech / VPI speech disorder, resulting in a more significant generalization effect and increased overall speech intelligibility. Therefore, the current study would like to investigate the effectiveness of different types speech intervention approaches in children and adolescences with CP±L.
Detailed description
Introduction of the study Cleft Palate with/without Lip (CP±L) Cleft Palate with or without Lip (CP±L) is one of the most well-known congenital anomalies worldwide. Epidemiological studies indicate that it affects approximately 1 in every 600 newborn babies, with rate of occurrences reported at 1.33 to 2.23 per 1000 live and stillbirths in the Chinese population. CP±L can present as syndromic or non-syndromic. Children with CP±L are at high risk of developing speech and communication difficulties due to a range of cleft-related etiologies. Some studies have also showed that children with CP±L may have language and literacy difficulties. Research showed that this group of children require speech-language intervention at different stages across their lifespan. Speech articulation, intelligibility, velopharyngeal competence and psychosocial states have been some of the recognized outcome measurements in this field.
Cleft Palate Speech/ Velopharyngeal Insufficiency Even with timely or early repair of the palate, children with CP+L may still experience cleft-related speech difficulties with a notable proportion of children having continuing velopharyngeal insufficiency (VPI). VPI refers to the presence of incomplete velopharyngeal closure during speech production. Non-articulation parameters of VPI include hypernasality, nasal airflow errors, and grimace, with hypernasality being the hallmark characteristic of VPI. Speech error patterns attributed to continuing VPI may involve what is termed as active compensatory articulatory gestures. For instance, children with cleft palate speech/VPI may have difficulty building up sufficient oral pressure to produce oral targets and may attempt to achieve closure at the level of the glottis resulting in replacement of oral pressure targets with glottal stops or fricatives. The loss of distinctive features and the ability to make meaningful contrasts potentially impacts on global outcomes such as speech understandability and acceptability adversely. Another possible articulation outcome of VPI is weak/nasalized consonants or complete replacement of oral pressure targets with their homorganic nasal counterparts e.g., /t/ replaced with /n/. Speech articulation outcomes unrelated to VPI also include lateralization errors and/or backing errors. A possible etiology of this is the presence of an oronasal fistula. In the latter context for instance, the child attempts to avoid the oronasal fistula by moving the tongue posterior to the fistula.
Direct Speech Intervention Current treatment approaches and the evidence In fact, treatment or treatment efficacy studies in cleft palate/VPI remain limited. A systematic review by Bessell et al. (2013) concluded that there was no sufficient evidence to support the efficacy of specific intervention approaches or techniques. There are only very few studies that have systematically compared different intervention approaches. Consensus on the effectiveness of different approaches remains inconclusive. The heterogeneity of the treatment approaches was also revealed by a subsequent exploratory study by Williams et al. (2021), which identified 49 distinct intervention methods reported by Speech Therapists in the UK, including strategies targeting very young children, such as complexity approaches, cued articulation, and cycles approaches. A more recent systematic review and meta-analysis by Sand et al (2021) also reiterated the low overall quality of evidence in treatment studies addressing cleft/VPI speech disorders, urging the need for interventions that consider the global benefits for clients. Treatment outcomes may include the overall speech intelligibility and communicative participation in everyday settings. With that said, a standardized outcome set is also advocated for future studies to enable a more holistic analysis of the treatment outcomes.
It is of vital importance to implement evidence-based speech intervention to achieve the optimal speech and resonance outcomes. Research has shown that active errors including lateralization, palatalization of fricatives and glottal articulation are habituated and active compensatory articulatory patterns that can be readjusted responsively by speech therapy intervention. On the contrary, passive errors, such as weak and/or nasalized consonants due to VPI, require surgical intervention. The use of glottal articulation may also reflect VPI and both surgical intervention and speech intervention are needed. Historically, speech intervention approaches can be categorized into motor-phonetic (MP) (+/- principles of motor learning) and linguistic-phonological (LP). Motor-phonetic approaches attempt to modify the phonetic errors individually by explicit instruction of the articulatory movement and extensive amount of practice. Motor-phonetic approaches can be undertaken with or without the application of principles of motor learning, which emphasize intensive practice, optimal task difficulty, and variable practice conditions for better retention and generalization. A case study by Hanley et al (2023) demonstrated that MP approach incorporating PML was found to be effective in improving the accuracy of both active and passive cleft speech errors in children with cleft palate. Generalization was also seen in untreated items after 8 weeks of face-to-face twice-weekly sessions. However, the necessity of conducting treatment on the passive cleft type errors remains questionable. Moreover, the generalization effect was solely evident for the targeted individual phonemes.
Increasingly, cleft palate speech/VPI speech disorder is being viewed as a phonological impairment rather than simply an articulation disorder. Howard et al. (2019) also stressed the phonological consequences of mechanical/structural constraints such as VPI in children with CP±L. Linguistic-phonological approaches, on the other hand, refer to phonological rule-based interventions, which attributes the child's speech sound errors to a disordered internal phonological system. Such approaches, target multiple speech sounds or sound classes, and assumes that there would be generalization across phonemes according to their distinctive features. Examples of LP approaches include the minimal pair approach, maximal oppositions and treatment of the empty set, multiple oppositions and Metaphon. A case study by Anderson et al (2024) employed the multiple oppositions approach to treat non-oral and passive CSCs. It revealed that the multiple oppositions intervention, as an LP approach, was found to be effective in improving the speech accuracy and intelligibility at conversational level, with sustained results also observed during the maintenance phase. The results suggested that the LP approach brought about a system-wide change of the phonological system in children with CP±L. Despite these findings, the limitations of small sample sizes in studies warrant caution in interpreting the generalizability of the results. Another randomized control trial with a larger sample size by Alighieri et al (2025) compared the effectiveness of MP and LP approaches (i.e. modified Metaphon approach). They found that while both MP and LP approaches could lead to generalization, LP approach resulted in a more superior generalization effects in terms of the speech outcomes within the same class and the overall percentage of speech accuracy. Nevertheless, it is crucial to recognize that these LP approaches still predominantly regard speech as a linear sequence of segments and speech sound errors as a set of rules. Target selection tends to be focused on individual phonemic errors in the children's phonetic repertoire and selected specific phonemes for treatment.
An Alternative Treatment Framework Application of non-linear phonology Phonological intervention approaches described above are often implemented under a linear paradigm, focusing on isolated phonemes. In contrast, non-linear phonological intervention, developed by Bernhardt and Stemberger (1994), seeks to capture the complexity of speech sounds organized in a hierarchical structure. It is common to observe a range of phonemes or even classes of phonemes being replaced with a single glottal stop or fricative in cleft palate speech. This consequently results in an extensive/ significant collapse of meaningful contrasts in the individual's speech, thereby VPI impacting negatively on speech understandability. As such, the premise of speech intervention would be to maximize overall understandability, acceptability and intelligibility. Target selection in cleft speech intervention would, therefore, be a critical component for successful treatment outcomes. Non-linear phonological intervention views a word as a multi-tiered structure. It emphasizes the broader nature of the phonological system and it believes that the system is more complex than speech sounds alon. With a holistic viewpoint of the speech sound system, the target selection and the treatment direction based on non-linear phonological framework would be different. Different research had investigated the use of non-linear phonology in speech intervention. Some of them had revealed the positive outcomes. It is believed that speech intervention guided by non-linear phonology framework would facilitate wider changes in the phonological system of children with cleft palate speech / VPI speech disorder. Subsequently, a more significant generalization effect across sound classes would be expected so that the overall speech intelligibility would be maximized. Yet, the application of non-linear phonology in the field of cleft/VPI population is yet to be adopted widely.
Research Questions
Indeed, SLPs reported a high degree of variability in selecting treatment approaches in their practice for children with CP±L. Such discrepancies may also be attributed to the lack of consensus in target selection and subsequent treatment directions. In view of this, the present study aims to conduct a randomized controlled trial to investigate the effectiveness of non-linear phonological intervention approach in improving speech outcomes in Cantonese-speaking children with CP±L and compare the effectiveness of LP approaches based on linear and non-linear phonology. The study will also further examine the phonological skills and functional impact on the individuals with CP±L after speech intervention. The followings are the proposed research questions:
(i) Is non-linear phonological intervention effective in improving speech outcomes in Cantonese-speaking children and adolescences with CP±L? Ho: Non-linear phonological intervention has no effect on improving speech outcomes in Cantonese-speaking children and adolescences with CP±L.
H1: Non-linear phonological intervention is effective in improving speech outcomes in Cantonese-speaking children and adolescences with CP±L.
(ii) Is a speech intervention approach based on non-linear phonological framework more effective in improving speech outcomes than the one based on linear phonology in Cantonese-speaking children and adolescences with CP±L? Ho: A speech intervention approach based on a non-linear phonological framework is not more effective in improving speech outcomes than one based on linear phonology in Cantonese-speaking children and adolescences with CP±L.
H1: A speech intervention approach based on a non-linear phonological framework is more effective in improving speech outcomes than one based on linear phonology in Cantonese-speaking children and adolescences with CP±L.
(iii) Are the phonological skills improved after phonological intervention in both groups? Ho: Phonological skills do not show significant improvement after phonological intervention in both groups of participants.
H1: Phonological skills show significant improvement after phonological intervention in both groups of participants.
(iv) Are the patient-reported outcomes also improved with the speech outcomes followed by the treatment? Ho: The patient-reported outcomes are not improved with the enhanced articulatory accuracy after treatment.
H1: The patient-reported outcomes are improved with the enhanced articulatory accuracy after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-linear based phonological (NLP) intervention group | Experimental | Behavioral: Non-linear based phonological speech intervention |
| Linear based phonological (LP) intervention group | Active comparator | Behavioral: Linear-based speech intervention |
| Waitlist control group | No intervention | –They will receive intervention after the study phase |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- (i) age of 4 to 17;
- (ii) primary repair of the cleft palate±lip done prior to 24 months old;
- (iii) presence of at least one CSCs type errors which must include non-oral CSCs and/or posterior CSCs;
- (iv) language proficiency in Cantonese.
Key exclusion criteria (4 listed)
- (i) a cognitive impairment;
- (ii) a hearing impairment based on pure-tone audiometry;
- (iii) known diagnosis of language difficulties/disorders;
- (iv) and/or other medical conditions that would affect their abilities to participate in the speech tasks independently.
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 |
|---|---|---|
| Non-linear based phonological speech interventionTraditionally, phonological speech intervention approaches (including the ones with children with cleft lip and palate) are often implemented under a linear paradigm, focusing on isolated phonemes. Non-linear phonological intervention, developed by Bernhardt and Stemberger (1994), seeks to capture the complexity of speech sounds organized in a hierarchical structure. It views a word as a multi-tiered structure and emphasizes the broader nature of the phonological system and it believes that the system is more complex than speech sounds alone. With a holistic viewpoint of the speech sound system, the target selection and the treatment direction based on non-linear phonological framework would be different. The premise of speech intervention would be to maximize overall understandability, acceptability and intelligibility. Target selection in cleft speech intervention would, therefore, be a critical component for successful treatment outcomes. | Behavioural | Non-linear based phonological (NLP) intervention group |
| Linear-based speech interventionLinear-based phonological approaches refer to speech interventions that target multiple phonemes according to the child's production of speech errors. Such approaches assume that there would be generalization across phonemes according to their distinctive features. Examples of linear-based approaches include the minimal pair approach, maximal oppositions and treatment of the empty set, multiple oppositions and Metaphon. | Behavioural | Linear based phonological (LP) intervention group |
Primary outcome
Perceputal Assessment of Cleft Speech - Cantonese: Understandability
Time frame: One week before the intervention, one week, one month and three months after the intervention
A scale measuring how understandable the speech is. 0 = Within normal limits - Speech is always easy to understand; 3 = Severe - Speech is hard to understand most or all of the time
Perceptual Assessment of Cleft Speech - Cantonese: Acceptability
Time frame: One week before the intervention, one week, one month and three months after the intervention
A scale that measures how acceptable the speech is. 0 = Within normal limits - Speech is normal ; 3 = Severe - Speech deviates from normal to a severe degree
Perceptual Assessment of Cleft Speech - Cantonese: Hypernasality
Time frame: One week before the intervention, one week, one month and three months after the intervention
A scale that measures how hypernasal the speech is. 0 = Within normal limits; 3 = Severe - Increased nasality heard on high and low vowels while some lose their identity
Perceptual Assessment of Cleft Speech - Cantonese: Hyponasality
Time frame: One week before the intervention, one week, one month and three months after the intervention
A scale that measures how hyponasal the speech is. 0 = Within normal limits/None; 1 = Present
Perceptual Assessment of Cleft Speech - Cantonese: Audible nasal emission
Time frame: One week before the intervention, one week, one month and three months after the intervention
A scale that measures whether audible nasal emission is present. 0 = Absent; 2 = Frequently heard, > 5 instances out of 50 high pressure consonants
Perceptual Assessment of Cleft Speech - Cantonese: Nasal turbulence
Time frame: One week before the intervention, one week, one month and three months after the intervention
A scale that measures whether nasal turbulence is present. 0 = Absent; 2 = Frequently heard, > 5 instances out of 50 high pressure consonants
Perceptual Assessment of Cleft Speech - Cantonese: Cleft speech errors
Time frame: One week before the intervention, one week, one month and three months after the intervention
Transcription of speech errors during the speech test. There are in total 4 types of cleft speech characteristics: (1) Anterior Oral; (2) Posterior Oral; (3) Non-Oral; and (4) Passive
Focus on the Outcomes of Communication Under Six" (Traditional Chinese - Hong Kong version) (FOCUS©-TC HK)
Time frame: One week before the intervention, one week, one month and three months after the intervention
FOCUS©-TC HK measures communicative participation. It evaluates how effectively a child uses communication to interact, play, and participate in everyday real-world activities at home, at school, and in the community. FOCUS©-TC HK is a questionnaire (usually 50 items) completed by parents or caregivers, who rate the child's communication behaviors on a 7-point scale. A higher Total Score indicates better communicative participation (max = 350 scores) A lower Total Score indicates that the child's speech or language difficulties are significantly impacting their daily social interactions and quality of life (min = 50 scores)
CLEFT-Q - Speech Function scale score
Time frame: One week before the intervention, one week, one month and three months after the intervention
The CLEFT-Q is a scientifically validated questionnaire used worldwide by doctors and speech therapists. The CLEFT-Q is a Patient-Reported Outcome Measure (PROM)-meaning it asks the child or young adult directly how they feel about their own life, appearance, and speech. This scale measures how the child perceives the physical clarity and mechanics of their own speech. In standard CLEFT-Q scoring, the raw answers are converted into a score from 0 to 100. For all CLEFT-Q scales, a higher score always indicates a better outcome (i.e., better function or better quality of life).
CLEFT-Q - Speech Distress Scale Score
Time frame: One week before the intervention, one week, one month and three months after the intervention
The CLEFT-Q is a scientifically validated questionnaire used worldwide by doctors and speech therapists. The CLEFT-Q is a Patient-Reported Outcome Measure (PROM)-meaning it asks the child or young adult directly how they feel about their own life, appearance, and speech. This scale measures the emotional burden and negative feelings caused by their speech difficulties. In standard CLEFT-Q scoring, the raw answers are converted into a score from 0 to 100. For all CLEFT-Q scales, a higher score always indicates a better outcome (i.e., better function or better quality of life).
CLEFT-Q - Psychological Scale Score
Time frame: One week before the intervention, one week, one month and three months after the intervention
The CLEFT-Q is a scientifically validated questionnaire used worldwide by doctors and speech therapists. The CLEFT-Q is a Patient-Reported Outcome Measure (PROM)-meaning it asks the child or young adult directly how they feel about their own life, appearance, and speech. This scale looks at the child's overall emotional well-being and self-esteem. In standard CLEFT-Q scoring, the raw answers are converted into a score from 0 to 100. For all CLEFT-Q scales, a higher score always indicates a better outcome (i.e., better function or better quality of life).
Percentage correct consonants-revised (PCC-R)
Time frame: One week before the intervention, one week, one month and three months after the intervention
It calculates how many consonants the child pronounced correctly out of the total number of consonants they attempted. The "Revised" (R) version counts distortions (like a slight lisp or mild nasal emission) as "correct," and only penalizes major errors like completely omitting a sound or substituting it with a completely different sound. 100% = perfectly correct production. Lower scores (e.g., < 50%) = Indicates a severe speech sound disorder where the child is dropping many sounds or swapping them out entirely, making them very hard to understand.
Percentage Correct Places (PCP)
Time frame: One week before the intervention, one week, one month and three months after the intervention
It evaluates if the child is making the sound in the correct place of articulation (e.g., using their lips for "p" or "m", or the back of their tongue for "k" or "g"), regardless of whether the airflow or voicing was perfectly correct. 100% = perfectly correct production. Lower scores (e.g., < 50%) = Indicates a severe speech sound disorder where the child is making the sounds with a wrong place of articulation.
Percentage Correct Manners (PCM)
Time frame: One week before the intervention, one week, one month and three months after the intervention
It evaluates if the child is using the correct manner of articulation (e.g., making a "stop" sound where air bursts out, a "fricative" where air hisses, or a "nasal" where air goes through the nose). 100% = perfectly correct production. Lower scores (e.g., < 50%) = Indicates a severe speech sound disorder where the child is making the sounds with a wrong manner of articulation.
Intelligibility in Context Scale - Traditional Chinese version (ICS-TC)
Time frame: One week before the intervention, one week, one month and three months after the intervention
The ICS is a 7-item questionnaire that asks parents to rate how well different groups of people (ranging from immediate family members to complete strangers) understand their child's speech. Each of the 7 questions is rated on a 5-point scale (from 1 = "Never" to 5 = "Always"). The total score will be converted to an average score. A higher score indicates excellent speech intelligibility. It means the child's speech is easily and consistently understood by everyone, regardless of whether they are talking to their parents, teachers, or strangers. (max = 5) A lower score indicates severe intelligibility issues. It means that almost no one can understand what the child is saying in daily situations. (min = 1)
1 secondary outcome
Percent scores of the informal tasks on phonological awareness
Time frame: One week before the intervention, one week, one month and three months after the intervention
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 9 Jul 2026.
- Background: PubMed 11847362Wong FW, King NM. A review of the rate of occurrence of cleft lip and palate in Chinese people. Hong Kong Med J. 1997 Mar;3(1):96-100.
- Background: PubMed 32945191Williams C, Harding S, Wren Y. An Exploratory Study of Speech and Language Therapy Intervention for Children Born With Cleft Palate +/- Lip. Cleft Palate Craniofac J. 2021 Apr;58(4):455-469. doi: 10.1177/1055665620954734. Epub 2020 Sep 18.
- Background: PubMed 38770980Andersen HS, Jorgensen LD, Wilstrup C, Willadsen E. Multiple oppositions intervention: effective phonological treatment of two children with cleft lip and palate and severe speech sound disorder. Clin Linguist Phon. 2025 Jan;39(1):57-78. doi: 10.1080/02699206.2024.2339308. Epub 2024 May 21.
- Background: PubMed 8958664Wakumoto M, Isaacson KG, Friel S, Suzuki N, Gibbon F, Nixon F, Hardcastle WJ, Michi K. Preliminary study of articulatory reorganisation of fricative consonants following osteotomy. Folia Phoniatr Logop. 1996;48(6):275-89. doi: 10.1159/000266422.
- Background: PubMed 28507866Tsangaris E, Wong Riff KWY, Goodacre T, Forrest CR, Dreise M, Sykes J, de Chalain T, Harman K, O'Mahony A, Pusic AL, Thabane L, Thoma A, Klassen AF. Establishing Content Validity of the CLEFT-Q: A New Patient-reported Outcome Instrument for Cleft Lip/Palate. Plast Reconstr Surg Glob Open. 2017 Apr 25;5(4):e1305. doi: 10.1097/GOX.0000000000001305. eCollection 2017 Apr.
- Background: PubMed 15013730Skelton SL. Concurrent task sequencing in single-phoneme phonologic treatment and generalization. J Commun Disord. 2004 Mar-Apr;37(2):131-55. doi: 10.1016/j.jcomdis.2003.08.002.
- Background: PubMed 9263938Shriberg LD, Austin D, Lewis BA, McSweeny JL, Wilson DL. The percentage of consonants correct (PCC) metric: extensions and reliability data. J Speech Lang Hear Res. 1997 Aug;40(4):708-22. doi: 10.1044/jslhr.4004.708.
- Background: PubMed 26567854Sell D, Mildinhall S, Albery L, Wills AK, Sandy JR, Ness AR. The Cleft Care UK study. Part 4: perceptual speech outcomes. Orthod Craniofac Res. 2015 Nov;18 Suppl 2(Suppl 2):36-46. doi: 10.1111/ocr.12112.
- Background: PubMed 10505144Sell 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.
- Background: PubMed 31307050Sell D, Sweeney T. Percent Consonant Correct as an Outcome Measure for Cleft Speech in an Intervention Study. Folia Phoniatr Logop. 2020;72(2):143-151. doi: 10.1159/000501095. Epub 2019 Jul 15.
- Background: PubMed 25087938Preston JL, McCabe P, Rivera-Campos A, Whittle JL, Landry E, Maas E. Ultrasound visual feedback treatment and practice variability for residual speech sound errors. J Speech Lang Hear Res. 2014 Dec;57(6):2102-15. doi: 10.1044/2014_JSLHR-S-14-0031.
- Background: PubMed 35678611Pereira VJ, So JYT, Tsang JMK, Choi WS, Tong MCF, Lee KYS. Speech Telepractice and Treatment Intensity in a Cantonese-Speaking Case with 22q11.2 Deletion Syndrome Following Late Diagnosis and Management of Velopharyngeal Dysfunction. Cleft Palate Craniofac J. 2023 Nov;60(11):1505-1512. doi: 10.1177/10556656221106042. Epub 2022 Jun 9.
- Individual participant dataSharing planned: No
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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.
Choco Ho Yin Ho, PhD Candidate principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-linear based phonological speech intervention and Linear-based speech intervention in people with Cleft Palate +/- Lip, run by Chinese 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 9 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceputal Assessment of Cleft Speech - Cantonese: Understandability (time frame: One week before the intervention, one week, one month and three months after the intervention). The study lists 15 primary outcomes in all. 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 NCT07692061, which also lists 38 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 9 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.