Speech-generating device to help communication in childhood dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.