Speech-generating device to help communication in childhood dementia
A Randomized Cross-over Trial Examining the Efficacy of Implementing a Speech-generating Device for Childhood Dementia
This project will test whether giving children with childhood dementia a speech-generating iPad app helps them communicate better than their usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Sponsor | Murdoch Childrens Research Institute Academic / other |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT07039084 on ClinicalTrials.gov |
What this trial studies
This is a randomized crossover trial enrolling 38 children (ages 3–12) with genetically confirmed childhood dementia who are minimally verbal. Each child will receive both conditions in different sequences: a speech-generating device program on an iPad plus twice-weekly 1-hour therapy sessions for six weeks, and a usual-care (no device) phase. Change in communication will be measured using an individualized, patient-defined 'communicative act' chosen with the family, with additional parent-reported and family-impact measures collected as secondary outcomes. Participants must pass a visual-motor screen, have adequate hearing, not already use a speech-generating device proficiently, and be able to participate in English-language sessions at the Melbourne site.
Who should consider this trial
Good fit: Children aged 3–12 with genetically confirmed childhood dementia who are minimally verbal (<20 spontaneous words), can tap an iPad (visual-motor screening passed), have adequate hearing, are not already proficient daily users of a speech-generating device, and can participate in English-language therapy.
Not a fit: Children who already use a speech-generating device proficiently, who cannot reliably tap or perceive the device due to severe visual/motor/hearing impairments, or who cannot participate in English-language sessions are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the device could meaningfully improve each child's ability to communicate and reduce family communication burden.
How similar studies have performed: High-tech augmentative and alternative communication (AAC) has shown benefits in other neurodevelopmental conditions, but rigorous trials specifically in childhood dementia are limited, making this approach relatively novel for this population.
Eligibility criteria
Show full inclusion / exclusion 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 (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.
Where this trial is running
Melbourne, Victoria
- Murdoch Children's Research Institute — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Angela T Morgan
- Email: angela.morgan@mcri.edu.au
- Phone: +61 (03) 8341 6458
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.