Comparing High and Low Intensity Speech Therapy in Children Aged 4 to 12 With Cleft Palate

What this Trial Is About

Researchers are evaluating the effects and cost-utility of two different speech therapy intensities for Belgian Dutch-speaking children aged 4 to 12 years with a cleft palate, with or without a cleft lip. The goal is to determine if a high intensity speech intervention leads to better speech outcomes, improved quality of life, and greater cost-effectiveness compared to the traditional low intensity approach. This large-scale randomized controlled trial aims to generate evidence to support wider clinical use of the more intensive therapy if proven beneficial. The study compares two speech therapy programs provided by trained first-line speech-language pathologists in private practice. One group receives high intensity therapy consisting of 30-minute sessions five times per week for two blocks of four weeks total 20 hours. The other group receives low intensity therapy with 30-minute sessions twice per week for 20 weeks also 20 hours total. Both programs focus on phonetic articulation and phonological principles using child-friendly techniques and games. Participants will be assessed multiple times before, during, and after therapy to measure speech improvements, such as consonant proficiency and intelligibility, as well as health-related quality of life. Researchers will also evaluate cost-utility based on quality-adjusted life years. Follow-ups continue up to three months post-intervention. The study includes various speech and communication assessments to track progress and aims to provide comprehensive data on therapy effectiveness and economic impact.

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