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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-12
SponsorUniversity Ghent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Children with syndromic clefts

Oronasal fistula

Velopharyngeal insufficiency

Hearing disabilities based on pure tone audiometry (>25 dB HL)

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

No treatment groups listed

Trial outcomes

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

Time frame
20 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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University Ghent

Lead sponsor

Research Foundation Flanders

Collaborator