Speech Intervention Frameworks in Cantonese-speaking Children and Adolescences With Cleft Palate +/- Lip

NCT07692061 | Enrolling By Invitation

• 1 other identifier: NTEC-2026-150
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cleft Palate +/- Lip

Keywords

cleft palate; cleft lip and palate; cleft lip; non-linear phonology; phonological intervention; speech Intervention

Outcome Measures

Primary Outcomes (15)

• 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

  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

  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

  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

  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

  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

  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

  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)

  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).

  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).

  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).

  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.

  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.

  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.

  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)

  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

  One week before the intervention, one week, one month and three months after the intervention

Study Arms (3)

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

Interventions

Non-linear based phonological speech intervention BEHAVIORAL

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.

Non-linear based phonological (NLP) intervention group

Linear-based speech intervention BEHAVIORAL

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.

Linear based phonological (LP) intervention group

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

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MeSH Terms

Conditions

Cleft Palate; Cleft Lip

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lip Diseases

Study Officials

• Choco Ho Yin Ho, PhD Candidate

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Speech Therapist, PhD Candidate

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 9, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)