Effectiveness and cost‐effectiveness of high‐intensity versus low‐intensity speech intervention in children with a cleft palate: Protocol for a randomized controlled trial

What is already known on the subject Speech intervention for children with a CP±L is traditionally provided once or twice per week for 30 min for months or years by first-line community SLPs in private practices or rehabilitation services. However, scientific evidence supporting the effectiveness of this rather low intervention intensity is limited. In recent decades, the focus has shifted to HISI, in which intervention sessions are concentrated within a short period of time, as a more promising intervention intensity. Several studies regarding HISI have shown promising results on speech and HRQoL in children with a CP±L compared with LISI. Clustering sessions also have the potential to be more cost-effective than LISI since fewer sessions are required to achieve the same outcomes, thus reducing the financial burden. However, comprehensive evaluations of cost-effectiveness are lacking. Therefore, before HISI can be implemented in clinical practice, more evidence is needed regarding its effectiveness and cost-effectiveness compared with LISI. What this paper adds to the existing knowledge The current project will compare the effectiveness of HISI and LISI in Belgian Dutch-speaking children with a CP±L aged between 4 and 12 years old. For this purpose, a large-scale randomized controlled trial will be performed. Primary outcome measures will include perceptual assessments of speech, while secondary outcome measures will assess multiple dimensions related to HRQoL, such as difficulties with speaking, emotional well-being, perceptions and attitudes related to speech through various psychosocial outcome measures. Additionally, the cost-effectiveness of both intervention intensities will be compared. What are the potential or actual clinical implications of this work? Providing more evidence regarding HISI can facilitate the implementation of this intervention model in first-line cleft speech care. This project has the potential to offer a solution to prolonged speech intervention by achieving satisfactory results more quickly, which could significantly reduce the duration of intervention and the associated financial burden.