Cleft Palate ChildrenNCT06105099
Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate
A study testing Motor-phonetic intervention, Phonological intervention and Combined phonetic-phonological intervention in people with Cleft Palate Children and Speech Disorders in Children, run by University Ghent at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cleft Palate Children, Speech Disorders in Children, Cleft Lip and Palate
- What is being tested?
- Motor-phonetic intervention, Phonological intervention and Combined phonetic-phonological intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2022to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Sciences
Ghent, 9000
Cassandra Alighieri, PhD, 0032478571262, cassandra.alighieri@ugent.be
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Motor-phonetic intervention, Phonological intervention, Combined phonetic-phonological intervention
- Keywords
- Randomized controlled trial, Speech therapy, Cleft lip and palate
- Medical subject headings
- Cleft Lip, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor-phonetic interventionBehavioural
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.
Phonological interventionBehavioural
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.
Combined phonetic-phonological interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Children with anterior oral cleft speech characteristics | Active comparator | To investigate the best speech therapy approach for children with anterior oral cleft speech characteristics, we will provide three different interventions. Receives: Behavioral: Motor-phonetic intervention; Behavioral: Phonological intervention; Behavioral: Combined phonetic-phonological intervention |
| Children with posterior oral cleft speech characteristics | Experimental | To investigate the best speech therapy approach for children with potserior oral cleft speech characteristics, we will provide three different interventions. Receives: Behavioral: Motor-phonetic intervention; Behavioral: Phonological intervention; Behavioral: Combined phonetic-phonological intervention |
| Children with non-oral cleft speech characteristics | Experimental | To investigate the best speech therapy approach for children with non-oral cleft speech characteristics, we will provide three different interventions. Receives: Behavioral: Motor-phonetic intervention; Behavioral: Phonological intervention; Behavioral: Combined phonetic-phonological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consonant proficiency
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Measured: Assessment immediately pre-intervention
Consonant proficiency
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Measured: Assessment immediately post-intervention
Consonant proficiency
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Measured: Assessment at 1 month post-intervention
Consonant proficiency
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Measured: Assessment at 3 months post-intervention
Consonant proficiency
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Measured: Assessment at 6 months post-intervention
Secondary outcomes (10)
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 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)
Measured: Assessment immediately pre-intervention
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 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)
Measured: Assessment immediately post-intervention
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 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)
Measured: Assessment at 1 month post-intervention
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 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)
Measured: Assessment at 3 months post-intervention
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 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)
Measured: Assessment at 6 months post-intervention
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 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).
Measured: Assessment immediately pre-intervention
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 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).
Measured: Assessment immediately post-intervention
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 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).
Measured: Assessment at 1 month post-intervention
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 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).
Measured: Assessment at 3 months post-intervention
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 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).
Measured: Assessment at 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Oct 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Palate ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105099
- Sponsor's protocol ID
- 12ZO323N
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06105099
- Acronym / sponsor ID
- 12ZO323N
- Keywords
- Randomized controlled trial, Speech therapy, Cleft lip and palate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Research Foundation Flanders
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children with anterior oral cleft speech characteristics | Active comparator | Behavioral: Motor-phonetic intervention, Behavioral: Phonological intervention, Behavioral: Combined phonetic-phonological interventionTo 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 | Experimental | Behavioral: Motor-phonetic intervention, Behavioral: Phonological intervention, Behavioral: Combined phonetic-phonological interventionTo investigate the best speech therapy approach for children with potserior oral cleft speech characteristics, we will provide three different interventions. |
| Children with non-oral cleft speech characteristics | Experimental | Behavioral: Motor-phonetic intervention, Behavioral: Phonological intervention, Behavioral: Combined phonetic-phonological interventionTo investigate the best speech therapy approach for children with non-oral cleft speech characteristics, we will provide three different interventions. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor-phonetic interventionChildren 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. | Behavioural | Children with anterior oral cleft speech characteristics, Children with non-oral cleft speech characteristics, Children with posterior oral cleft speech characteristics |
| Phonological interventionThe 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. | Behavioural | Children with anterior oral cleft speech characteristics, Children with non-oral cleft speech characteristics, Children with posterior oral cleft speech characteristics |
| Combined phonetic-phonological interventionChildren 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 | Behavioural | Children with anterior oral cleft speech characteristics, Children with non-oral cleft speech characteristics, Children with posterior oral cleft speech characteristics |
Primary outcome
Consonant proficiency
Time frame: Assessment immediately pre-intervention
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Consonant proficiency
Time frame: Assessment immediately post-intervention
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Consonant proficiency
Time frame: Assessment at 1 month post-intervention
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Consonant proficiency
Time frame: Assessment at 3 months post-intervention
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Consonant proficiency
Time frame: Assessment at 6 months post-intervention
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
10 secondary outcomes
Intelligibility in Context
Time frame: Assessment immediately pre-intervention
Intelligibility in Context
Time frame: Assessment immediately post-intervention
Intelligibility in Context
Time frame: Assessment at 1 month post-intervention
Intelligibility in Context
Time frame: Assessment at 3 months post-intervention
Intelligibility in Context
Time frame: Assessment at 6 months post-intervention
Health-related quality of life
Time frame: Assessment immediately pre-intervention
Health-related quality of life
Time frame: Assessment immediately post-intervention
Health-related quality of life
Time frame: Assessment at 1 month post-intervention
Health-related quality of life
Time frame: Assessment at 3 months post-intervention
Health-related quality of life
Time frame: Assessment at 6 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor-phonetic intervention, Phonological intervention and Combined phonetic-phonological intervention in people with Cleft Palate Children and Speech Disorders in Children, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consonant proficiency (time frame: Assessment immediately pre-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.