Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate

Condition(s) studied

Investigational drug(s) / intervention(s)

High-intensity speech therapy for children with cleft palate: High-intensity speech therapy consisted of five 30-minute speech therapy sessions per week over two separate 2-week periods, with a 6-week rest period between the two periods. The intervention comprised a total of 10 hours of speech therapy.

Low-intensity speech therapy for children with cleft palate: Low-intensity speech therapy consisted of two 30-minute speech therapy sessions per week over a 10-week period. The intervention comprised a total of 10 hours of speech therapy.

Study summary

A cleft (lip and) palate 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 a cleft (lip and) palate based on the perceptions of the providers of the intervention (primary care speech-language pathologists) and the recipients of the intervention (children with a cleft (lip and) palate and their parents). 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 a cleft (lip and) palate. 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

Primary outcome measure(s)

• Perceived acceptability of high- and low-intensity speech intervention — Day 1
  Perceptions and experiences of children with cleft palate, their parents/caregivers, and speech-language pathologists regarding the acceptability of high-intensity and low-intensity speech therapy. Acceptability will be explored through semi-structured interviews and examined across the seven constructs of the Theoretical Framework of Acceptability: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. Qualitative thematic analysis will be used to identify perceptions, experiences, and factors influencing acceptability of the two treatment intensities.

Trial sites (1)

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