NCT07039084 Using a Speech-Generating Device to Support Communication in Childhood Dementia
| NCT ID | NCT07039084 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Murdoch Childrens Research Institute |
| Condition | Childhood Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2027-05 |
Trial Parameters
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Brief Summary
Individuals with childhood dementia experience loss of developmental skills and 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 childhood dementia. 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 assessments and attend a total of 2 x 1-hour therapy session per week for 6 weeks.
Eligibility Criteria
Inclusion Criteria: * Is between the ages of 3 and 12 years, inclusive, at the time of enrolment * Has a genetically confirmed Childhood Dementia (via genetic report from a qualified geneticist), meeting the definition outlined in Elvidge et al. (2023) or is a condition listed on https://www.childhooddementia.org/what-is-childhood-dementia/childhood-dementia-disorders * 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 20 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