A mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft palate ± cleft lip: Parents' and children's perspectives.

Background: Ultrasound visual biofeedback (UVBF) has the potential to be useful for the treatment of compensatory errors in speakers with cleft palate ± lip (CP±L), but there is little research on its effectiveness, or on how acceptable families find the technique. This study reports on parents' and children's perspectives on taking part in a pilot randomized control trial of UVBF compared with articulation intervention.

Aims: To determine the acceptability of randomization, UVBF and articulation intervention to families. We set feasibility criteria of at least 75% of responses rated as acceptable or positive in order to determine progression from a pilot to a full randomized control trial.

Methods & Procedures: A total of 19 families who received UVBF therapy (11 families) and articulation intervention (eight families) were invited to participate. Mixed methods were employed: two questionnaires to determine the acceptability of UVBF and articulation intervention, respectively; and semi-structured focus groups/interviews. Questionnaires were analysed for frequency of positive versus negative acceptability and the focus groups/interviews were analysed using thematic analysis and coded using the theoretical framework of acceptability.

Outcomes & Results: More than 75% of families rated randomization as acceptable and more than 75% of families rated both interventions as acceptable, with the caveat that half of the participants did not wish to continue articulation intervention after the study. For some families, this was because they felt further intervention was not required. Six families (three in each intervention) volunteered to take part in the focus groups/interviews. Results showed more positive than negative themes regarding acceptability, particularly affective attitude where high levels of enjoyment were expressed, although some participants found the articulation intervention 'boring'. In both groups, there was a considerable burden involved in travelling to the hospital location.

Conclusions & Implications: Randomization in a clinical trial is acceptable to families; UVBF and articulation intervention are acceptable and indeed enjoyable. The burden of the additional outcome measures required for a clinical trial is manageable, although there is a travel burden for participants. Future studies should seek to mitigate the travel burden by considering additional locations for intervention.

What This Paper Adds: What is already known on the subject UVBF shows potential for teaching children with speech sound disorders new articulations. Previous studies looking at the acceptability of using ultrasound in speech intervention have only asked for the drawbacks of the intervention: finding the ultrasound gel to be cold and sticky and the probe to be uncomfortable. SLTs, however, believe that the technique offers advantages due to its ability to visualize tongue movements. What this paper adds to the existing knowledge This study asks parents and children for their full views about using ultrasound in speech intervention and compared this to articulation intervention. We also asked parents how they feel about being randomized to one of these interventions. Results were positive for both interventions, with parents highlighting the importance of intelligible speech to their child. Children enjoyed both interventions, though the articulation intervention could be 'boring' or 'repetitive'. For all families, there was a considerable burden travelling to clinics. What are the potential or actual clinical implications of this work? Clinicians can be assured that both articulation therapy and ultrasound therapy are acceptable to families. Efforts could be made to ensure that articulation intervention is not repetitive and that appointments are offered at locations which are accessible to families where possible.