Protocol for SonoSpeech Cleft Pilot: a mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate

Background: Children with cleft lip and palate can continue to have problems producing clear speech after surgery. This can lead to social, emotional, and educational challenges. Typical treatment involves teaching children the correct tongue movements to produce speech sounds. This is known as articulation intervention. However, this intervention is challenging because the tongue is hidden from view and movements are difficult to see and describe. This pilot randomized control trial will try a new treatment, ultrasound visual biofeedback (U-VBF) versus standard articulatory intervention for children with cleft lip and palate, as comparison. Feasibility outcomes will be determined. Methods/design: The Sonospeech project will enroll up to 40 children with cleft lip and palate aged 4;6 to 16 in a mixed-methods randomized controlled trial with blinded assessors. Children will receive either six sessions of U-VBF or articulation intervention. The primary goals of this pilot are to assess the feasibility and inform the design of a full-scale RCT of U-VBF for children with cleft speech characteristics. This will be achieved by determining the following outcome measures: recruitment/attrition rates; measures of pre-post follow-up completion; and acceptability of the randomization and interventions to families. Discussion: Larger trials of speech interventions for children with cleft lip and palate are needed. This pilot/feasibility study will determine whether a larger randomized control trial comparing ultrasound and articulation interventions is feasible. Trial registration: ISRCTN, ISRCTN17441953. Registered 22 March 2021. See Table 2 in Appendix 1 for all items.