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Recruiting NCT06105099

Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate

No phase Interventional Cleft Palate Children Speech Disorders in Children Cleft Lip and Palate Speech Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Motor-phonetic intervention, Phonological intervention, Combined phonetic-phonological intervention.
Who it may be relevant to
Registry conditions: Cleft Palate Children, Speech Disorders in Children, Cleft Lip and Palate, Speech Therapy. Basic parameters: 4 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

One Size Does Not Fit All: From a Common Approach Towards Performance-specific Speech Intervention and Long-term Learning in Children With a Cleft Palate

Overview

Speech therapy in children with a palate deals with two scientific challenges that will be addressed in this project. The first challenge is selecting the best speech approach for a child with a specific cleft speech characteristic (CSC). Many speech therapists use a 'one-size-fits-all' approach to treat compensatory CSCs resulting in poor short- and long-term speech outcomes. To increase the effectiveness and quality of cleft speech care, it is necessary to find the best match between a specific therapy and a given type of CSC. Therefore, this proposal will compare the effect of 3 different speech approaches on the speech and quality of life in Dutch speaking children with different types of CSCs. The second challenge is selecting the best speech approach to enhance long-term learning and transfer of newly established speech skills to untrained consonants. To date, research mainly focused on immediate therapy effects. It is unknown if permanent speech changes occur. Hence, this project will also investigate the short-term and long-term learning effects (retention and transfer) of the different speech approaches from the first objective. This proposal will improve evidence-based and patient-tailored cleft speech therapy.

Detailed description

Objective 1: To compare the (immediate) effect of three speech therapy approaches (i.e.

a motor-phonetic approach, a phonological approach, and a combined phonetic-phonological approach) on the speech and health-related quality of life (HRQoL) in Belgian Dutch-speaking children with a CP±L and different subtypes of compensatory CSCs (anterior oral CSCs, posterior oral CSCs, or non-oral CSCs) measured by perceptual and psychosocial outcome measures.

Objective 2: To measure the short-term effects (performance to learning) and the long-term learning effects (retention and transfer) of the three different speech therapy approaches (i.e. a motor-phonetic approach, a phonological approach, and a combined phonetic-phonological approach) on the speech and HRQoL in Belgian Dutch-speaking children with a CP±L and different subtypes of compensatory CSCs measured by perceptual and psychosocial outcome measures.

Interventions

  • Behavioral Motor-phonetic intervention
    Children will receive phonetic articulation therapy treating consonants in a phoneme-by-phoneme basis, emphasizing phonetic placement and shaping techniques. Phonetic articulation therapy includes a progression of the target consonant from isolated level, syllable level, word level, sentence level, spontaneous speech level in five different steps: identification of the target consonant using visual, tactile, and auditory feedback techniques, discrimination between the used and targeted consona
  • Behavioral Phonological intervention
    The phonological approach consists of two phases. In the first phase, the child's attention is drawn to the contrastive features of the speech sound system which are relevant to the target consonants. Terms that describe the sound features will be introduced using words on the child's level, e.g. in the case of active nasal fricatives the words 'nose' and 'mouth' will be used. Child-friendly games will be played to illustrate the contrast between the concepts followed by activities that focus on
  • Behavioral Combined phonetic-phonological intervention
    Children will receive motor-phonetic articulation therapy supplemented with phonological principles. Therapy will be provided following the same five steps as the 'motor-phonetic group'. However, articulation errors will not be treated in a phoneme-by-phoneme basis. In contrast, multiple errors will be targeted simultaneously by focusing on a process. For example, if the child produces glottal stops for the /t/ and the /p/, these sounds will be treated simultaneously as sounds requiring oral fro

Primary outcome measures

  • Consonant proficiency [Time frame: Assessment immediately pre-intervention]
  • Consonant proficiency [Time frame: Assessment immediately post-intervention]
  • Consonant proficiency [Time frame: Assessment at 1 month post-intervention]
  • Consonant proficiency [Time frame: Assessment at 3 months post-intervention]
  • Consonant proficiency [Time frame: Assessment at 6 months post-intervention]
Secondary outcome measures (10)
  • Intelligibility in Context [Time frame: Assessment immediately pre-intervention]
  • Intelligibility in Context [Time frame: Assessment immediately post-intervention]
  • Intelligibility in Context [Time frame: Assessment at 1 month post-intervention]
  • Intelligibility in Context [Time frame: Assessment at 3 months post-intervention]
  • Intelligibility in Context [Time frame: Assessment at 6 months post-intervention]
  • Health-related quality of life [Time frame: Assessment immediately pre-intervention]
  • Health-related quality of life [Time frame: Assessment immediately post-intervention]
  • Health-related quality of life [Time frame: Assessment at 1 month post-intervention]
  • Health-related quality of life [Time frame: Assessment at 3 months post-intervention]
  • Health-related quality of life [Time frame: Assessment at 6 months post-intervention]

Eligibility criteria

Inclusion criteria

  • Belgian Dutch-speaking children with a cleft palate with or without a cleft lip
  • Aged between 4 and 12 years
  • Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist

Exclusion criteria

  • Children with syndromic clefts
  • Oronasal fistula
  • Velopharyngeal insufficiency
  • Hearing disabilities based on pure tone audiometry (>25 dB HL)
  • Cognitive and/or related learning disabilities or neuromuscular disorders

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Department of Rehabilitation Sciences — Ghent

Identifiers

NCT: NCT06105099 · 12ZO323N

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗