Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate

NCT06105099 | Recruiting DMC

• 1 other identifier: 12ZO323N
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

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

Keywords

Randomized controlled trial; Speech therapy; Cleft lip and palate

Outcome Measures

Primary Outcomes (5)

• Consonant proficiency

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

  Assessment immediately pre-intervention

• Consonant proficiency

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

  Assessment immediately post-intervention

• Consonant proficiency

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

  Assessment at 1 month post-intervention

• Consonant proficiency

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

  Assessment at 3 months post-intervention

• Consonant proficiency

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

  Assessment at 6 months post-intervention

Secondary Outcomes (10)

• Intelligibility in Context

  Assessment immediately pre-intervention

• Intelligibility in Context

  Assessment immediately post-intervention

• Intelligibility in Context

  Assessment at 1 month post-intervention

• Intelligibility in Context

  Assessment at 3 months post-intervention

• Intelligibility in Context

  Assessment at 6 months post-intervention

Study Arms (3)

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.

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.

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.

Behavioral: Motor-phonetic intervention; Behavioral: Phonological intervention; Behavioral: Combined phonetic-phonological intervention

Interventions

Motor-phonetic intervention BEHAVIORAL

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.

Children with anterior oral cleft speech characteristics; Children with non-oral cleft speech characteristics; Children with posterior oral cleft speech characteristics

Phonological intervention BEHAVIORAL

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 with anterior oral cleft speech characteristics; Children with non-oral cleft speech characteristics; Children with posterior oral cleft speech characteristics

Combined phonetic-phonological intervention BEHAVIORAL

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

Children with anterior oral cleft speech characteristics; Children with non-oral cleft speech characteristics; Children with posterior oral cleft speech characteristics

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)

Department of Rehabilitation Sciences

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Cleft Lip; Communication Disorders

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 27, 2023
• Study Start: October 1, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

BE (1)