High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Caregivers and Speech-language Pathologists

NCT06895395 | Recruiting

• 1 other identifier: ONZ-2024-0191
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

A cleft (lip and) palate (CP±L) is the most common congenital abnormality of the face and skull with a significant social impact, affecting speech, hearing, feeding, oral behavior, dentition and satisfaction with appearance. These consequences have a long-term and negative impact on social integration and well-being. The World Health Organization (WHO) highlights the significant financial costs, including morbidity, health care costs, emotional distress and social exclusion for patients, their families and society. The purpose of this study is to compare high- and low-intensity speech intervention in children with CP±L based on the perceptions of the providers of the intervention (primary care speech-language pathologists) and the recipients of the intervention (children with CP±L and their caregivers). Individual semi-structured interviews will be conducted with both intervention providers and recipients to explore perceptions and experiences, as well as acceptability of the two speech intervention intensities. Potential participants will be told that the interview will be recorded. The actual interviews will take place at a location and time that is most convenient for the participants. Each interview will be recorded using a Roland R-05 high-quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographics. In addition, data regarding the type of cleft, time and manner of closure of the cleft, any secondary surgery and otological/audiological data will be collected from the medical records of the children with CP±L. Based on this qualitative study, possible adjustments to the high-intensity therapy protocol can be made. In doing so, these modifications will be relevant to these key stakeholders. This will also facilitate the implementation and widespread use of high-intensity speech therapy in clinical speech therapy practice.

Conditions

Cleft Lip and Palate; Speech Disorders in Children

Keywords

Cleft lip and palate; Qualitative research; Speech therapy; Interviews; Speech intervention intensity

Outcome Measures

Primary Outcomes (1)

• Perceptions and acceptability of low/high intensive speech intervention

  Participants will be interviewed and can talk about their experiences and perceptions regarding the speech intervention intensity. The acceptability of both high and low intensive therapy will be examined

  20 weeks

Interventions

High intensive combined phonetic-phonological intervention BEHAVIORAL

High intensity speech intervention 5 times 30' per week for 2 times 4 weeks

Low intensive combined phonetic-phonological intervention BEHAVIORAL

low intensity speech intervention 2 times 30' per week for 20 weeks

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The population are children born with a cleft palate (with or without a cleft lip). They are 4 to 12 years old and have at least one compensatory speech error in their speech.

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)

Ghent University Hospital

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

Central Study Contacts

Tara Mouton

CONTACT

+32 496 44 63 08; tara.mouton@ugent.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: March 26, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)