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

NCT06381713 | Recruiting DMC

• 1 other identifier: ONZ-2024-0158
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Randomized controlled trial; Speech therapy; Cleft lip and palate

Outcome Measures

Primary Outcomes (3)

• Consonant proficiency

  Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)

  Assessment 2 weeks pre-intervention, immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 1 week post-intervention, at 2 weeks post-intervention, at 3 months post-intervention

• Incremental cost-utility ratio

  The cost-utility of the high intensity speech intervention compared to the low intensity speech intervention will be examined by calculating the ratio of the incremental costs to the incremental health effects (QALYs) called the incremental cost-utility ratio (ICUR), calculated as Cost intervention - Cost control / Effect intervention - Effect control. The EQ-5D-Youth version will be used for children aged 8-12 years and the EQ-5D proxy version for children aged 4-7 years to collect information on HRQoL ("utilities"). Cost information will be obtained using a self-reported questionnaire on health care use.

  After a 12-week rest period (high intensity arm), at 3 months post-intervention

• Incremental cost-effectiveness ratio

  The cost-effectiveness of the high intensity speech intervention compared to the low intensity speech intervention will be examined by calculating the ratio of the incremental costs to the incremental health effects (percentage correctly produced consonants) called the incremental cost-effectiveness ratio (ICER), calculated as Cost intervention - Cost control / Effect intervention - Effect control. The effectiveness will be estimated using the primary outcome (percentage correctly produced consonants) obtained from the randomized controlled trial. Cost information will be obtained using a self-reported questionnaire on health care use.

  After a 12-week rest period (high intensity arm), at 3 months post-intervention

Secondary Outcomes (6)

• Intelligibility in Context

  Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention

• Health-related quality of life

  Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention

• Speech Function

  Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention

• Speech Distress

  Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention

• Communication attitudes of children aged 4 and 5 years

  Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention

Study Arms (2)

High intensive speech therapy

EXPERIMENTAL

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.

Behavioral: High intensive combined phonetic-phonological intervention

Low intensive speech therapy

ACTIVE COMPARATOR

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.

Behavioral: Low intensive combined phonetic-phonological intervention

Interventions

High intensive combined phonetic-phonological intervention 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.

High intensive speech therapy

Low intensive combined phonetic-phonological intervention 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.

Low intensive speech therapy

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Communication Disorders; Cleft Lip

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kristiane Van Lierde, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fien Allemeersch

CONTACT

+32474128135; Fien.Allemeersch@UGent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 24, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)