The ETKA study - Impact of early therapy termination on treated phonemes in conversational speech tasks in children aged 5 to 6 years with phonologically delayed development: protocol for a multicenter randomized controlled trial

Background: Children with speech and language disorders frequently display speech sound disorders, the treatment of which improves childrens ability to communicate. However, there is a significant gap between those therapy capacities needed and those provided in Austria. In addition, as the effect of early therapy termination has not yet been systematically evaluated, the aim of this project is to investigate the influence of an early therapy termination on phonological processes in children aged 5 to 6 years with phonologically delayed development. Methods/Design: Forty 5- to 6-year-old children, currently participating in speech therapies in the Upper Austrian region will participate in this multicenter randomized controlled trial. The participants will be randomly allocated to either the intervention group (early therapy termination) or the control group (uninterrupted ongoing therapy) by envelop randomization. Phoneme accuracy in spontaneous speech determined during 15 minutes of conversational sampling and phoneme accuracy for single-word production determined with the PLAKKS assessment will be used to assess therapy efficacy. The results from both groups will be compared regarding the correct use of the target phoneme/consonant cluster in conversational speech situation. Discussion: This study will explore the effect of early therapy termination on speech sound disorders in 5- to 6-yearold children. If an early termination exhibits non-inferiority to the current ongoing therapy, therapy resources could be used more effectively. Subsequently, earlier therapy starts for more children could be facilitated and negative consequences of delayed therapies could be counteracted. Ethics and dissemination: The study was approved by an institutional review board (ID: A-2019-035). Dissemination will be achieved through peer-review conferences and journals. Trial registration: The study is registered at ClinicalTrials.gov (Identifier: NCT03972891, Registered 4 June 2019, https://www.clinicaltrials.gov/ct2/show/NCT03972891).