Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate

NCT ID: NCT06381713

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-26
• Study Completion Date: 2027-12-31

Brief Summary

Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice.

Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders.

Detailed Description

Objective 1: Conduct a large-scale randomized controlled trial to compare the short- and long-term sustainable effects of two different speech intervention intensities (i.e. high intensity speech intervention: 5x30 min/week during 2x4 weeks (2x10 hours) and low intensity speech intervention: 2x30 min/week during 20 weeks (20 hours)) on the speech and quality of life in Belgian Dutch-speaking children with a cleft palate with or without a cleft lip. Speech intervention will be provided by first-line speech language pathologists in private practices who will receive thorough training before the onset of the trial.

Hypothesis 1: Based on the state-of-the-art and our proof-of-concept, it is assumed that 20 hours of high intensity speech intervention will lead to superior speech outcomes and health-related quality of life compared to 20 hours of low intensity speech intervention.

Objective 2: To compare the cost-utility in quality-adjusted life years of two different speech intervention intensities (i.e. high intensity speech intervention: 5x30 min/week during 2x4 weeks (2x10 hours) and low intensity speech intervention: 2x30 min/week during 20 weeks (20 hours)) in Belgian Dutch-speaking children with a cleft palate with or without a cleft lip. Demonstrating the cost-effectiveness of high intensity speech intervention will facilitate implementation and utilization of this protocol in clinical practice as less money has to be spent in order to gain one life year in full health (QALY) when providing high intensity speech intervention compared to low intensity speech intervention.

Hypothesis 2: Besides the superior speech outcomes and health related quality of life in a shorter intervention time (cfr. hypothesis 1), it is hypothesized that less money has to be spent in order to gain one life year in full health (QALY) in the high intensity intervention group. In other words, it is hypothesized that high intensity intervention will be more cost-effective compared to low intensity speech intervention.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High intensive speech therapy

To investigate the (cost-)effectiveness of speech therapy for children with a cleft palate (with of without a cleft lip), we will provide a high-intensive speech intervention.

Group Type: EXPERIMENTAL

High intensive combined phonetic-phonological intervention

Intervention Type: BEHAVIORAL

Children will receive phonetic articulation therapy supplemented by phonological principles. Consonants will be treated with emphasis on phonetic placement and shaping techniques. Phonetic articulation therapy includes five different steps:(1) identification of the target consonant using visual, tactile, and auditory feedback techniques,(2) discrimination between the used and targeted consonant, (3) variation and correction, (4) stabilize the target, and (5) maintenance of the target. A next level will be introduced when the child is able to correctly produce the sound in 80% of the time with minimal cues from the therapist. Multiple errors will be targeted simultaneously by focusing on a process. Child-friendly games will be played to illustrate the contrast between concepts, for example glottal 'throat' sounds and oral 'mouth' sounds. Exercises will be embedded in meaningful language contexts such as minimal pairs.

Therapy will be provided 5 times 30' per week for 2 times 4 weeks.

Low intensive speech therapy

To investigate the (cost-)effectiveness of speech therapy for children with a cleft palate (with of without a cleft lip), we will provide a low-intensive speech intervention.

Group Type: ACTIVE_COMPARATOR

Low intensive combined phonetic-phonological intervention

Intervention Type: BEHAVIORAL

Children will receive phonetic articulation therapy supplemented by phonological principles. Consonants will be treated with emphasis on phonetic placement and shaping techniques. Phonetic articulation therapy includes five different steps:(1) identification of the target consonant using visual, tactile, and auditory feedback techniques,(2) discrimination between the used and targeted consonant, (3) variation and correction, (4) stabilize the target, and (5) maintenance of the target. A next level will be introduced when the child is able to correctly produce the sound in 80% of the time with minimal cues from the therapist. Multiple errors will be targeted simultaneously by focusing on a process. Child-friendly games will be played to illustrate the contrast between concepts, for example glottal 'throat' sounds and oral 'mouth' sounds. Exercises will be embedded in meaningful language contexts such as minimal pairs.

Therapy will be provided 2 times 30' per week for 20 weeks.

Interventions

High intensive combined phonetic-phonological intervention

Children will receive phonetic articulation therapy supplemented by phonological principles. Consonants will be treated with emphasis on phonetic placement and shaping techniques. Phonetic articulation therapy includes five different steps:(1) identification of the target consonant using visual, tactile, and auditory feedback techniques,(2) discrimination between the used and targeted consonant, (3) variation and correction, (4) stabilize the target, and (5) maintenance of the target. A next level will be introduced when the child is able to correctly produce the sound in 80% of the time with minimal cues from the therapist. Multiple errors will be targeted simultaneously by focusing on a process. Child-friendly games will be played to illustrate the contrast between concepts, for example glottal 'throat' sounds and oral 'mouth' sounds. Exercises will be embedded in meaningful language contexts such as minimal pairs.

Therapy will be provided 5 times 30' per week for 2 times 4 weeks.

Intervention Type: BEHAVIORAL

Low intensive combined phonetic-phonological intervention

Children will receive phonetic articulation therapy supplemented by phonological principles. Consonants will be treated with emphasis on phonetic placement and shaping techniques. Phonetic articulation therapy includes five different steps:(1) identification of the target consonant using visual, tactile, and auditory feedback techniques,(2) discrimination between the used and targeted consonant, (3) variation and correction, (4) stabilize the target, and (5) maintenance of the target. A next level will be introduced when the child is able to correctly produce the sound in 80% of the time with minimal cues from the therapist. Multiple errors will be targeted simultaneously by focusing on a process. Child-friendly games will be played to illustrate the contrast between concepts, for example glottal 'throat' sounds and oral 'mouth' sounds. Exercises will be embedded in meaningful language contexts such as minimal pairs.

Therapy will be provided 2 times 30' per week for 20 weeks.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristiane Van Lierde, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

University Hospital Ghent

Ghent, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Fien Allemeersch

Role: CONTACT

Fien.Allemeersch@UGent.be

+32474128135

Facility Contacts

Kristiane Van Lierde

Role: primary

hiruz.ctu@uzgent.be

+3293320530

Other Identifiers

ONZ-2024-0158

Identifier Type: -

Identifier Source: org_study_id