Using a Speech-Generating Device to Support Communication in Rare Genetic Conditions
Individuals with rare genetic conditions may experience a delay or loss of developmental skills. Many have limited verbal speech. The aim of this clinical trial is to examine how well a speech-generating device supports the communication skills of participants with a rare genetic condition. The speech-generating device
| Condition(s) | Genetic Disease, Nonverbal Communication, Augmentative and Alternative Communication, Rare Genetic Disease, Rare Genetic Disorders |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Individuals with rare genetic conditions may experience a delay or loss of developmental skills. Many have limited verbal speech. The aim of this clinical trial is to examine how well a speech-generating device supports the communication skills of participants with a rare genetic condition. The speech-generating device is a communication program loaded onto an iPad. This is a crossover trial, meaning that each participant will receive both the treatment (device) and a control (usual care; no device) phase. The order in which each participant receives the device versus the usual care (no device) will depend on which group the participant is assigned to. The changes in communication in each phase will then be compared. During the trial, participants can expect to complete a series of assessm |
| Who can participate | Inclusion Criteria: * Is between the ages of 3 and 12 years, inclusive, at the time of enrolment * Has a diagnosis of a rare genetic disorder * Passes a visual-motor screening test, therefore being able to tap on an iPad spontaneously or by imitation and has adequate hearing * Considered "minimally verbal" with less than 50 spontaneous words (or gestalts) at baseline assessments, confirmed with the LVIS. * Is not currently using a speech-generating device with proficiency (i.e. using the device as a main mode of communication on a daily basis). * Is English-speaking or consents to therapy being conducted in English (parents will need to be able to complete the parent-reported measures in English) Exclusion Criteria: * Has an additional or dual genetic variation (as this is likely to cause |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Lead sponsor | Murdoch Childrens Research Institute |
| Locations | Melbourne, Victoria, Australia |
| Start date | 2025-11-03 |
| NCT ID | NCT07039084 |
| Official listing | https://clinicaltrials.gov/study/NCT07039084 |