Using a Speech-Generating Device to Support Communication in Rare Genetic Conditions

Recruiting now · Not applicable

Conditions studied: Genetic Disease, Nonverbal Communication, Augmentative and Alternative Communication, Rare Genetic Disease, Rare Genetic Disorders

In brief

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 assessments and attend a total of 2 x 1-hour therapy session per week for 6 weeks.

Key facts

Study ID

NCT07039084

Run by

Murdoch Childrens Research Institute

People needed

38

Starts

2025-11-03

Expected to finish

2027-05-01

Last updated by the study team

2026-05-26

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• Murdoch Children's Research Institute — Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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