An interventional study of Motor-phonetic intervention and Phonological intervention in Cleft Palate Children, Speech Disorders in Children and Cleft Lip and Palate, sponsored by University Ghent. Recruiting at 1 site in Belgium. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by University Ghent · Not applicable, Interventional, and Treatment
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.
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.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 135 is above the median of 30 across 116 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →University Ghent is the lead sponsor of 350 studies on the registry; 86 are open to participants now.
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Exclusion Criteria:
To investigate the best speech therapy approach for children with anterior oral cleft speech characteristics, we will provide three different interventions.
Behavioral: Motor-phonetic intervention · Behavioral: Phonological intervention · Behavioral: Combined phonetic-phonological intervention
To investigate the best speech therapy approach for children with potserior oral cleft speech characteristics, we will provide three different interventions.
Behavioral: Motor-phonetic intervention · Behavioral: Phonological intervention · Behavioral: Combined phonetic-phonological intervention
To investigate the best speech therapy approach for children with non-oral cleft speech characteristics, we will provide three different interventions.
Behavioral: Motor-phonetic intervention · Behavioral: Phonological intervention · Behavioral: Combined phonetic-phonological intervention
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
Consonant proficiency
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Time frame: Assessment immediately pre-intervention
Consonant proficiency
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Time frame: Assessment immediately post-intervention
Consonant proficiency
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Time frame: Assessment at 1 month post-intervention
Consonant proficiency
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Time frame: Assessment at 3 months post-intervention
Consonant proficiency
Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)
Time frame: Assessment at 6 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Assessment at 6 months post-intervention
Plan to share: Undecided
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Started Oct 2022 (actual). Primary completion is estimated for Sep 2025, 35 months after the start.
Of 64 non-industry interventional studies with no phase under Cleft Lip, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 33. This study's planned 35 months is above that.
Counting every sponsor, half of 65 studies reached it within 22 months; a quarter within 15 and three quarters within 33.
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