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

U

University Ghent

Status

Enrolling

Conditions

Cleft Palate Children
Speech Therapy
Cleft Lip and Palate
Speech Disorders in Children

Treatments

Behavioral: Motor-phonetic intervention
Behavioral: Combined phonetic-phonological intervention
Behavioral: Phonological intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06105099
12ZO323N

Details and patient eligibility

About

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.

Full 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.

Enrollment

135 estimated patients

Sex

All

Ages

4 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

135 participants in 3 patient groups

Children with anterior oral cleft speech characteristics
Active Comparator group
Description:
To investigate the best speech therapy approach for children with anterior oral cleft speech characteristics, we will provide three different interventions.
Treatment:
Behavioral: Motor-phonetic intervention
Behavioral: Phonological intervention
Behavioral: Combined phonetic-phonological intervention
Children with posterior oral cleft speech characteristics
Experimental group
Description:
To investigate the best speech therapy approach for children with potserior oral cleft speech characteristics, we will provide three different interventions.
Treatment:
Behavioral: Motor-phonetic intervention
Behavioral: Phonological intervention
Behavioral: Combined phonetic-phonological intervention
Children with non-oral cleft speech characteristics
Experimental group
Description:
To investigate the best speech therapy approach for children with non-oral cleft speech characteristics, we will provide three different interventions.
Treatment:
Behavioral: Motor-phonetic intervention
Behavioral: Phonological intervention
Behavioral: Combined phonetic-phonological intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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