Using a Speech-Generating Device to Support Communication in Childhood Dementia
A Randomized Cross-over Trial Examining the Efficacy of Implementing a Speech-generating Device for Childhood Dementia
Murdoch Childrens Research Institute
38 participants
Nov 3, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria5
- Has an additional or dual genetic variation (as this is likely to cause multiple complications and increase variability),
- Is extremely ill or has progressed into a later stage of their disease (i.e. child has clinically significant loss of vision, hearing, fine motor skills, or is unable to adequately attend sessions due to illness),
- This is to ensure treatment is beneficial, reduce harm and reduce attrition rates.
- Lives outside of the state of Victoria (making it difficult for in-person appointments)
- Inability or unwillingness of participant or legally acceptable representative to give written informed consent.
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Interventions
The device is an iPad loaded with a grid-based and speech-generating communication application - a suitable application for the participant is determined at the beginning of the trial. This device is used in all 12 therapy sessions and implemented by a qualified speech pathologist in a natural, play-based setting.
Participants will continue their current model of care. This means that if participants are receiving speech therapy locally, they may continue to do so given that no speech-generating device is introduced or used during this time. Participants will check in with the researching clinician at least once a week via telehealth or phone call - the aim is to stay in contact with families and reduce loss to follow-up. The clinician will also monitor treatment integrity and document any differences that may be present during this phase.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07039084