Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorUniversity Ghent
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Children with syndromic clefts
Oronasal fistula
Velopharyngeal insufficiency
Hearing disabilities based on pure tone audiometry (>25 dB HL)
Trial design
Design model
Parallel
Treatments tested in this trial
High intensive combined phonetic-phonological intervention
BehavioralChildren 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 combined phonetic-phonological intervention
BehavioralChildren 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: High intensive speech therapyExperimental treatment 1 intervention
Group B: Low intensive speech therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Consonant proficiency
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Time frame
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-intervention2
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.
Time frame
After a 12-week rest period (high intensity arm), at 3 months post-intervention3
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.
Time frame
After a 12-week rest period (high intensity arm), at 3 months post-interventionSecondary outcomes
1
Intelligibility in Context
To assess possible transfer of learned speech skills to contexts outside the therapy setting, the Intelligibility in Context Scale (ICS) will be administered. 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)
Time frame
Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention2
Health-related quality of life
To evaluate the psychosocial impact of the interventions, the Velopharyngeal insufficiency Effects on Life outcomes (VELO) questionnaire will be administered. 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 health related quality of life.
Time frame
Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention3
Speech Function
The subscale "Speech Function" from the Dutch CLEFT-Q will be administered to measure how often someone has trouble speaking. This scale consists of 10 questions. Scores range from 0 to 100. Higher scores indicate less trouble speaking. This scale was developed and validated for children with CP±L between 8 and 29 years of age. Consequently, this scale will only be administered to children aged 8 years and older.
Time frame
Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-intervention4
Speech Distress
The subscale "Speech Distress" from the Dutch CLEFT-Q will be administered to assess in more detail the feelings someone has regarding speaking. This scale consists of 10 questions. Scores range from 0 to 100. Higher scores indicate less negative feelings. This scale was developed and validated for children with CP±L between 8 and 29 years of age. Consequently, this questionnaire will only be administered to children aged 8 years and older.
Time frame
Assessment immediately pre-intervention, after 10 hours of therapy, after a 12-week rest period, immediately post-intervention, at 3 months post-interventionSponsors and contacts
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University Ghent
Lead sponsor
Research Foundation Flanders
Collaborator
Source ClinicalTrials.gov