A Mixed-Methods Pilot Randomised 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 has the potential to be useful for the treatment of compensatory errors in speakers with Cleft Palate +/- Lip, but there is little research on its effectiveness, nor on how acceptable families find the technique. This study reports on parents’ and children’s perspectives on taking part in a pilot randomised control trial of ultrasound visual biofeedback compared to articulation intervention. Aims: To determine the acceptability of randomisation, ultrasound visual biofeedback, 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 full randomised control trial. Methods & Procedures: 19 families who received ultrasound visual biofeedback therapy (11 families) and articulation intervention (8 families) were invited to participate. Mixed methods were employed: two questionnaires to determine the acceptability of ultrasound visual biofeedback 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 randomisation as acceptable and more than 75% of families rated both interventions as acceptable, with the caveat that half of participants did not wish to continue articulation intervention after the study. Six families (3 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: Randomisation in a clinical trial is acceptable to families; ultrasound visual biofeedback and articulation intervention are acceptable and indeed enjoyable. The burden of the additional outcome measures required for a clinical trial are manageable, although there is a travel burden for participants. Future studies should seek to mitigate travel burden by considering additional locations for intervention.