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

Not Applicable

Recruiting

• Conditions: Cleft Palate Children; Speech Disorders in Children; Cleft Lip and Palate; Speech Therapy
• Interventions: Behavioral: Motor-phonetic intervention; Behavioral: Phonological intervention; Behavioral: Combined phonetic-phonological intervention

• Registration Number: NCT06105099
• Lead Sponsor: University Ghent

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.

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-27
• Last Update Posted: 2023-10-27
• Primary Completion: 2025-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Children with anterior oral cleft speech characteristics	Motor-phonetic intervention	To investigate the best speech therapy approach for children with anterior oral cleft speech characteristics, we will provide three different interventions.
Children with non-oral cleft speech characteristics	Motor-phonetic intervention	To investigate the best speech therapy approach for children with non-oral cleft speech characteristics, we will provide three different interventions.
Children with non-oral cleft speech characteristics	Phonological intervention	To investigate the best speech therapy approach for children with non-oral cleft speech characteristics, we will provide three different interventions.
Children with non-oral cleft speech characteristics	Combined phonetic-phonological intervention	To investigate the best speech therapy approach for children with non-oral cleft speech characteristics, we will provide three different interventions.
Children with anterior oral cleft speech characteristics	Phonological intervention	To investigate the best speech therapy approach for children with anterior oral cleft speech characteristics, we will provide three different interventions.
Children with anterior oral cleft speech characteristics	Combined phonetic-phonological intervention	To investigate the best speech therapy approach for children with anterior oral cleft speech characteristics, we will provide three different interventions.
Children with posterior oral cleft speech characteristics	Motor-phonetic intervention	To investigate the best speech therapy approach for children with potserior oral cleft speech characteristics, we will provide three different interventions.
Children with posterior oral cleft speech characteristics	Combined phonetic-phonological intervention	To investigate the best speech therapy approach for children with potserior oral cleft speech characteristics, we will provide three different interventions.
Children with posterior oral cleft speech characteristics	Phonological intervention	To investigate the best speech therapy approach for children with potserior oral cleft speech characteristics, we will provide three different interventions.

Primary Outcome Measures

Name	Time	Method
Consonant proficiency	Assessment at 6 months post-intervention	Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)

Secondary Outcome Measures

Name	Time	Method
Intelligibility in Context	Assessment at 6 months post-intervention	To assess possible transfer of learned speech skills to contexts outside the therapy setting, the Intelligibility in Context Scale (ICS) will be administered before and after intervention. The ICS rates the degree to which children's speech is understood by different partners (caregivers, immediate and extended family, friends, acquaintances, teachers, and strangers) on a 5-point scale (1 - never intelligible to 5 - always intelligible)
Health-related quality of life	Assessment at 6 months post-intervention	To evaluate the psychosocial impact of the interventions, the Velopharyngeal insufficiency Effects on Life outcomes (VELO) questionnaire will be administered before and after the intervention. This tool consists of a caregiver and child report (for children older than 8 years) addressing different domains: speech limitation, swallowing problems, situational difficulty, emotional impact, perception by others, and caregiver impact.; The higher the score, the better the quality of life. The VELO-scores range from 0 (minimal quality of life) to 100 (maximal quality of life).

Trial Locations

Locations (1)

Department of Rehabilitation Sciences; 🇧🇪 Ghent, Belgium