What this Trial Is About

Researchers are investigating the effects and cost-utility of two different speech therapy intensities in children aged 4 to 12 years with a cleft palate, with or without a cleft lip. The study aims to compare standard low intensity therapy, which is traditionally provided twice a week for 30 minutes over many months, to a novel high intensity approach involving more frequent sessions over a shorter period. This large-scale randomized controlled trial will assess speech outcomes, quality of life, and cost-effectiveness to determine if the high intensity program can offer better results and greater value for children with cleft palate. The trial compares two speech intervention programs delivered by trained first-line speech-language pathologists in private practices. The high intensity intervention consists of 5 sessions of 30 minutes per week for two periods of 4 weeks each (totaling 20 hours). The low intensity intervention involves 2 sessions of 30 minutes per week for 20 weeks (also totaling 20 hours). Both programs use combined phonetic and phonological approaches focusing on consonant articulation with steps including identification, discrimination, correction, stabilization, and maintenance. Therapy uses child-friendly games and meaningful language exercises to support learning. Participants will be evaluated on consonant proficiency at multiple time points before, during, and after the intervention, including a 12-week rest period and 3 months post-intervention. The study will also measure incremental cost-utility and cost-effectiveness ratios to understand the economic impact of each therapy intensity. Speech outcomes, quality of life, and costs will be systematically tracked to support possible wider clinical adoption of the high intensity program.

Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate