Clinical trial NCT06105099: Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cleft Palate Children
Speech Disorders in Children
Cleft Lip and Palate
Speech Therapy
Keywords: Randomized controlled trial
Speech therapy
Cleft lip and palate
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2023-10-27
Enrollment: 135
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Consonant proficiency
timeFrame: Assessment immediately pre-intervention
measure: Consonant proficiency
timeFrame: Assessment immediately post-intervention
measure: Consonant proficiency
timeFrame: Assessment at 1 month post-intervention
measure: Consonant proficiency
timeFrame: Assessment at 3 months post-intervention
measure: Consonant proficiency
timeFrame: Assessment at 6 months post-intervention
Secondary outcomes:
measure: Intelligibility in Context
timeFrame: Assessment immediately pre-intervention
measure: Intelligibility in Context
timeFrame: Assessment immediately post-intervention
measure: Intelligibility in Context
timeFrame: Assessment at 1 month post-intervention
measure: Intelligibility in Context
timeFrame: Assessment at 3 months post-intervention
measure: Intelligibility in Context
timeFrame: Assessment at 6 months post-intervention
measure: Health-related quality of life
timeFrame: Assessment immediately pre-intervention
measure: Health-related quality of life
timeFrame: Assessment immediately post-intervention
measure: Health-related quality of life
timeFrame: Assessment at 1 month post-intervention
measure: Health-related quality of life
timeFrame: Assessment at 3 months post-intervention
measure: Health-related quality of life
timeFrame: Assessment at 6 months post-intervention
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Rehabilitation Sciences
Study officials:
References: