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Clinical Trials in Australia / NCT07039084
Recruiting Not applicable

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

NCT07039084 · tracked via the Priya Life Science Australia tracker
Sponsor
Murdoch Childrens Research Institute
Phase
Not applicable
Started
2025-11-03
Last updated
2026-05-26

Condition(s) studied

Genetic DiseaseNonverbal CommunicationAugmentative and Alternative CommunicationRare Genetic DiseaseRare Genetic Disorders

Investigational drug(s) / intervention(s)

Speech-generating deviceControl

Speech-generating device: 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.

Control: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
12 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Changes in the frequency of target communicative act related to the patient-defined outcome determined at the beginning of the trial — Baseline, Week 0, Week 6 and Week 12
    Each participant will have specific communicative acts related to a patient-defined outcome determined at the beginning of the trial with each participant and their family. This means that each participant will have an individualised communication outcome which will be targeted during treatment sessions. The change in frequency of these specific communicative acts will be measured. The mean difference of each period (comparing the start to end of the phase) will be determined and compared between the 2 periods.

Trial sites (1)

FacilityCityRegionStatus
Murdoch Children's Research Institute Melbourne Victoria Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07039084 on ClinicalTrials.gov ↗ ← All trials in Australia