- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06105099
Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate
One Size Does Not Fit All: From a Common Approach Towards Performance-specific Speech Intervention and Long-term Learning in Children With a Cleft Palate
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.
Study Overview
Status
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ghent, Belgium, 9000
- Recruiting
- Department of rehabilitation sciences
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Contact:
- Cassandra Alighieri, PhD
- Phone Number: 0032478571262
- Email: cassandra.alighieri@ugent.be
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Children with anterior oral cleft speech characteristics
To investigate the best speech therapy approach for children with anterior oral cleft speech characteristics, we will provide three different interventions.
|
Children will receive phonetic articulation therapy treating consonants in a phoneme-by-phoneme basis, emphasizing phonetic placement and shaping techniques. Phonetic articulation therapy includes a progression of the target consonant from isolated level, syllable level, word level, sentence level, spontaneous speech level in five different steps: identification of the target consonant using visual, tactile, and auditory feedback techniques, 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 90% of the time with minimal cues from the therapist. The phonological approach consists of two phases. In the first phase, the child's attention is drawn to the contrastive features of the speech sound system which are relevant to the target consonants. Terms that describe the sound features will be introduced using words on the child's level, e.g. in the case of active nasal fricatives the words 'nose' and 'mouth' will be used. Child-friendly games will be played to illustrate the contrast between the concepts followed by activities that focus on the contrasts in non-speech sounds, in which child and therapist will alternate between being listener and speaker. At the end of this phase, minimal word pairs (e.g. tap/cap), only produced by the therapist, will be used to facilitate the child's awareness of sounds in words and meaningful differences based on distinctive features. In the second phase, the child will produce minimal pairs providing the opportunity to monitor his/her speech and to make self-corrections.
Children will receive motor-phonetic articulation therapy supplemented with phonological principles.
Therapy will be provided following the same five steps as the 'motor-phonetic group'.
However, articulation errors will not be treated in a phoneme-by-phoneme basis.
In contrast, multiple errors will be targeted simultaneously by focusing on a process.
For example, if the child produces glottal stops for the /t/ and the /p/, these sounds will be treated simultaneously as sounds requiring oral front placements.
Exercises will be embedded in meaningful language contexts such as minimal pairs
|
Experimental: Children with posterior oral cleft speech characteristics
To investigate the best speech therapy approach for children with potserior oral cleft speech characteristics, we will provide three different interventions.
|
Children will receive phonetic articulation therapy treating consonants in a phoneme-by-phoneme basis, emphasizing phonetic placement and shaping techniques. Phonetic articulation therapy includes a progression of the target consonant from isolated level, syllable level, word level, sentence level, spontaneous speech level in five different steps: identification of the target consonant using visual, tactile, and auditory feedback techniques, 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 90% of the time with minimal cues from the therapist. The phonological approach consists of two phases. In the first phase, the child's attention is drawn to the contrastive features of the speech sound system which are relevant to the target consonants. Terms that describe the sound features will be introduced using words on the child's level, e.g. in the case of active nasal fricatives the words 'nose' and 'mouth' will be used. Child-friendly games will be played to illustrate the contrast between the concepts followed by activities that focus on the contrasts in non-speech sounds, in which child and therapist will alternate between being listener and speaker. At the end of this phase, minimal word pairs (e.g. tap/cap), only produced by the therapist, will be used to facilitate the child's awareness of sounds in words and meaningful differences based on distinctive features. In the second phase, the child will produce minimal pairs providing the opportunity to monitor his/her speech and to make self-corrections.
Children will receive motor-phonetic articulation therapy supplemented with phonological principles.
Therapy will be provided following the same five steps as the 'motor-phonetic group'.
However, articulation errors will not be treated in a phoneme-by-phoneme basis.
In contrast, multiple errors will be targeted simultaneously by focusing on a process.
For example, if the child produces glottal stops for the /t/ and the /p/, these sounds will be treated simultaneously as sounds requiring oral front placements.
Exercises will be embedded in meaningful language contexts such as minimal pairs
|
Experimental: Children with non-oral cleft speech characteristics
To investigate the best speech therapy approach for children with non-oral cleft speech characteristics, we will provide three different interventions.
|
Children will receive phonetic articulation therapy treating consonants in a phoneme-by-phoneme basis, emphasizing phonetic placement and shaping techniques. Phonetic articulation therapy includes a progression of the target consonant from isolated level, syllable level, word level, sentence level, spontaneous speech level in five different steps: identification of the target consonant using visual, tactile, and auditory feedback techniques, 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 90% of the time with minimal cues from the therapist. The phonological approach consists of two phases. In the first phase, the child's attention is drawn to the contrastive features of the speech sound system which are relevant to the target consonants. Terms that describe the sound features will be introduced using words on the child's level, e.g. in the case of active nasal fricatives the words 'nose' and 'mouth' will be used. Child-friendly games will be played to illustrate the contrast between the concepts followed by activities that focus on the contrasts in non-speech sounds, in which child and therapist will alternate between being listener and speaker. At the end of this phase, minimal word pairs (e.g. tap/cap), only produced by the therapist, will be used to facilitate the child's awareness of sounds in words and meaningful differences based on distinctive features. In the second phase, the child will produce minimal pairs providing the opportunity to monitor his/her speech and to make self-corrections.
Children will receive motor-phonetic articulation therapy supplemented with phonological principles.
Therapy will be provided following the same five steps as the 'motor-phonetic group'.
However, articulation errors will not be treated in a phoneme-by-phoneme basis.
In contrast, multiple errors will be targeted simultaneously by focusing on a process.
For example, if the child produces glottal stops for the /t/ and the /p/, these sounds will be treated simultaneously as sounds requiring oral front placements.
Exercises will be embedded in meaningful language contexts such as minimal pairs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Consonant proficiency
Time Frame: Assessment immediately pre-intervention
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Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
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Assessment immediately pre-intervention
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Consonant proficiency
Time Frame: Assessment immediately post-intervention
|
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
|
Assessment immediately post-intervention
|
Consonant proficiency
Time Frame: Assessment at 1 month post-intervention
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Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
|
Assessment at 1 month post-intervention
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Consonant proficiency
Time Frame: Assessment at 3 months post-intervention
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Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
|
Assessment at 3 months post-intervention
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Consonant proficiency
Time Frame: Assessment at 6 months post-intervention
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Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
|
Assessment at 6 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intelligibility in Context
Time Frame: Assessment immediately pre-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)
|
Assessment immediately pre-intervention
|
Intelligibility in Context
Time Frame: Assessment immediately 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)
|
Assessment immediately post-intervention
|
Intelligibility in Context
Time Frame: Assessment at 1 month 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)
|
Assessment at 1 month post-intervention
|
Intelligibility in Context
Time Frame: Assessment at 3 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)
|
Assessment at 3 months post-intervention
|
Intelligibility in Context
Time Frame: 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)
|
Assessment at 6 months post-intervention
|
Health-related quality of life
Time Frame: Assessment immediately pre-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). |
Assessment immediately pre-intervention
|
Health-related quality of life
Time Frame: Assessment immediately 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). |
Assessment immediately post-intervention
|
Health-related quality of life
Time Frame: Assessment at 1 month 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). |
Assessment at 1 month post-intervention
|
Health-related quality of life
Time Frame: Assessment at 3 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). |
Assessment at 3 months post-intervention
|
Health-related quality of life
Time Frame: 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). |
Assessment at 6 months post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Neurodevelopmental Disorders
- Lip Diseases
- Mouth Abnormalities
- Stomatognathic System Abnormalities
- Jaw Abnormalities
- Jaw Diseases
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Language Disorders
- Cleft Palate
- Cleft Lip
- Speech Disorders
- Communication Disorders
Other Study ID Numbers
- 12ZO323N
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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