Genetic DiseaseNCT07039084
Using a Speech-Generating Device to Support Communication in Rare Genetic Conditions
A study testing Speech-generating device in people with Genetic Disease and Nonverbal Communication, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Genetic Disease, Nonverbal Communication, Augmentative and Alternative Communication
- What is being tested?
- Speech-generating device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Nov 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Murdoch Children's Research Institute
Melbourne, Victoria
Angela T Morgan, +61 (03) 8341 6458, angela.morgan@mcri.edu.au
Shui J Wong, +61 (03) 9345 5533, jen.wong@mcri.edu.au
About this study
Official title: A Randomized Cross-over Trial Examining the Efficacy of Implementing a Speech-generating Device for Rare Genetic Conditions
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.
Read the detailed description
In Australia, a disease is considered rare if it affects less than 1 in 2,000 individuals. There are over 7,000 rare genetic conditions, with three quarters affecting children. Rare diseases are often serious and progressive, presenting with ongoing health and developmental challenges, including speech and language disorders.
Augmentative and alternative communication (AAC) is one of the ways to support children with little speech and children with rare genetic conditions should have access to such tools as early as possible to maximise learning opportunities. However, the efficacy of high-tech AAC methods, such as speech generating devices, for children with rare genetic conditions have not been rigorously examined.
In this randomised cross-over trial, 38 participants with a rare genetic condition will be randomised into two groups (n=19 per group), which will determine the sequence of treatment delivery. The primary aim of this trial is to evaluate the efficacy of implementing a speech-generating device on communication outcomes compared with their usual care (i.e. no device). Change in communication will be measured using a patient-defined outcome - this outcome is a 'communicative act' chosen at the beginning of the trial with participants and their family. This means that each participant will have an individualised communication outcome which will be targeted during treatment sessions and measured in assessment sessions. The secondary aims include parent-reported communication, family impact and language/communication competence.
Each participant will complete screening, preference testing and baseline assessments about 2-4 weeks before randomisation. Further assessments will be completed before and after each phase. For each participant, the change in assessment scores between the start and the end of each period will be calculated. The mean difference in the change in total score between the two periods will then be calculated.
Each participant is expected to be involved in the study for 12 weeks after randomisation. This is split into two phases (6 weeks each). In the treatment (device) phase, each participant will receive two 1-hour therapy sessions per week, for 6 weeks, with a communication device (or 12 x 1-hour therapy within a 6-week treatment phase). The device is implemented by a qualified speech pathologist on the project team and can occur at Murdoch Children's Research Institute or at the participants' home.
The control (usual care) phase involves another 6 weeks, however, no therapy sessions are provided by the project team. Weekly phone-call or telehealth check-ins will be performed to ensure things are going smoothly.
- Conditions
- Genetic Disease, Nonverbal Communication, Augmentative and Alternative Communication, Rare Genetic Disease, Rare Genetic Disorders
- Being tested
- Speech-generating device, Control
- Medical subject headings
- Genetic Diseases, Inborn, Nonverbal Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech-generating deviceDevice
Also called augmentative and alternative communication, communication 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.
ControlOther
Also called Usual care
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 group | Role | What they receive |
|---|---|---|
| Treatment then Control | Other | The arm receives the intervention (device), then the control Receives: Device: Speech-generating device; Other: Control |
| Control then Treatment | Other | The arm receives the control, then the treatment (device) Receives: Device: Speech-generating device; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the frequency of target communicative act related to the patient-defined outcome determined at the beginning of the trial
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.
Measured: Baseline, Week 0, Week 6 and Week 12
Secondary outcomes (5)
Changes in overall communicative acts
Changes in overall communicative acts measured through the difference in total number of all communicative acts observed between the two periods. This will be measured by the overall number of communicative acts observed during an assessment session regardless of the relation to the patient-defined outcome. The change in the total score between the start and the end of each period will be calculated for each participant. The mean difference in the change in total score between the two periods will then be calculated.
Measured: Baseline, Week 0, Week 6 and Week 12
Changes in parent-reported communication via the Communication Matrix total score
Changes in parent-reported communication skills will be measured using the Communication Matrix total score. For each participant the change in the total score between the start and the end of each period will be calculated. The mean difference in the total score between the two periods will then be calculated. The Communication Matrix allows for the quantification of reported behaviours, e.g. the total score is calculated by scoring each cell in the Matrix (each cell representing a communication behaviour at a particular level of communication). Each cell is scored with 0 (Not used), 1 (Emerging - inconsistently used) or 2 (Mastered - used proficiently at all times). These points are summed to obtain a score between 0 to 160 and a percentage is obtained to represent the proportion of communication behaviours Mastered.
Measured: Baseline, Week 0, Week 6 and Week 12
Changes in family and caregiver impact assessed via the Family Impact of Assistive Technology Scale for Augmentative and Alternative Communication (FIATS-AAC)
Changes in parent satisfaction, social impact and the mental health of caregivers will be assessed using the Family Impact of Assistive Technology Scale for Augmentative and Alternative Communication (FIATS-AAC). Each item is scored on a 7-point Likert scale and assigned into one of the 13 domains (Behavior, Caregiver Relief, Contentment, Doing Activities, Education, Energy, Face-to-Face Communication, Family Roles, Finances, Security, Self Reliance, Social Versatility, Supervision). The mean score for each domain (ranging between 1 to 7) are added together to produce the total score (ranging between 13 to 91). A higher domain score suggests a higher (more positive) functional level of that specific domain. The change in scores between the start and the end of each period will be calculated for each participant. The mean difference in the score between the two periods will then be calculated.
Measured: Baseline, Week 0, Week 6 and Week 12
Changes in family and caregiver impact assessed via semi-structured interviews
Changes in parent satisfaction, social impact and the mental health of caregivers will be assessed using a semi-structured interview as seen in Vogel et al. (2016), completed at baseline and at the end of each phase. Thematic analysis will be used to identify any themes that are present during these interviews and descriptively compare the differences identified.
Measured: Baseline, Week 6 and Week 12
Changes in Language / Communication Competence assessed via the Low-Verbal Investigatory Survey
Changes in the language and communication competence between the start and the end of each period for each participant will be determined via the Low-Verbal Investigatory Survey (LVIS). The survey produces a Verbal Communication score (between 0 to 15), an Alternative Communication score (between 0 to 11) and a Nonverbal Communication score (between 0 to 5). A higher score suggests greater communication competence in each of those areas. The mean differences in the LVIS scores between the two periods will then be calculated.
Measured: Baseline, Week 0, Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start3 Nov 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Genetic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039084
- Sponsor's protocol ID
- 115839
- Status last verified
- Sep 2025
- First submitted
- 18 Jun 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data set collected for the analysis of this trial will be made available 12 months following analysis and publication of the primary outcome. The following will be made available long-term for use by future researchers from a recognised research institution: * Individual participant data that underlie the results reported after anonymisation/deidentification (text, tables, figures and appendices), * Trial protocol, Participant Information and Consent Form (PICF), * Statistical Analysis Plan (SAP), statistical code. Note that the data sharing of de-identified speech and language data is an Optional Consent for participants.
Publications
Ganz JB, Morin KL, Foster MJ, Vannest KJ, Genc Tosun D, Gregori EV, Gerow SL. High-technology augmentative and alternative communication for individuals with intellectual and developmental disabilities and complex communication needs: a meta-analysis. Augment Altern Commun. 2017 Dec;33(4):224-238. doi: 10.1080/07434618.2017.1373855. Epub 2017 Sep 19.
PubMed 28922953Nunn K, Williams K, Ouvrier R. The Australian Childhood Dementia Study. Eur Child Adolesc Psychiatry. 2002 Apr;11(2):63-70. doi: 10.1007/s007870200012.
PubMed 12033746Light J, McNaughton D. Communicative Competence for Individuals who require Augmentative and Alternative Communication: A New Definition for a New Era of Communication? Augment Altern Commun. 2014 Mar;30(1):1-18. doi: 10.3109/07434618.2014.885080.
PubMed 30952185Elvidge KL, Christodoulou J, Farrar MA, Tilden D, Maack M, Valeri M, Ellis M, Smith NJC; Childhood Dementia Working Group. The collective burden of childhood dementia: a scoping review. Brain. 2023 Nov 2;146(11):4446-4455. doi: 10.1093/brain/awad242.
PubMed 37471493
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-over Trial Examining the Efficacy of Implementing a Speech-generating Device for Rare Genetic Conditions
- ClinicalTrials.gov ID
- NCT07039084
- Acronym / sponsor ID
- 115839
- Conditions
- Genetic Disease, Nonverbal Communication, Augmentative and Alternative Communication, Rare Genetic Disease, Rare Genetic Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In Australia, a disease is considered rare if it affects less than 1 in 2,000 individuals. There are over 7,000 rare genetic conditions, with three quarters affecting children. Rare diseases are often serious and progressive, presenting with ongoing health and developmental challenges, including speech and language disorders.
Augmentative and alternative communication (AAC) is one of the ways to support children with little speech and children with rare genetic conditions should have access to such tools as early as possible to maximise learning opportunities. However, the efficacy of high-tech AAC methods, such as speech generating devices, for children with rare genetic conditions have not been rigorously examined.
In this randomised cross-over trial, 38 participants with a rare genetic condition will be randomised into two groups (n=19 per group), which will determine the sequence of treatment delivery. The primary aim of this trial is to evaluate the efficacy of implementing a speech-generating device on communication outcomes compared with their usual care (i.e. no device). Change in communication will be measured using a patient-defined outcome - this outcome is a 'communicative act' chosen at the beginning of the trial with participants and their family. This means that each participant will have an individualised communication outcome which will be targeted during treatment sessions and measured in assessment sessions. The secondary aims include parent-reported communication, family impact and language/communication competence.
Each participant will complete screening, preference testing and baseline assessments about 2-4 weeks before randomisation. Further assessments will be completed before and after each phase. For each participant, the change in assessment scores between the start and the end of each period will be calculated. The mean difference in the change in total score between the two periods will then be calculated.
Each participant is expected to be involved in the study for 12 weeks after randomisation. This is split into two phases (6 weeks each). In the treatment (device) phase, each participant will receive two 1-hour therapy sessions per week, for 6 weeks, with a communication device (or 12 x 1-hour therapy within a 6-week treatment phase). The device is implemented by a qualified speech pathologist on the project team and can occur at Murdoch Children's Research Institute or at the participants' home.
The control (usual care) phase involves another 6 weeks, however, no therapy sessions are provided by the project team. Weekly phone-call or telehealth check-ins will be performed to ensure things are going smoothly.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment then Control | Other | Device: Speech-generating device, Other: ControlThe arm receives the intervention (device), then the control |
| Control then Treatment | Other | Device: Speech-generating device, Other: ControlThe arm receives the control, then the treatment (device) |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech-generating deviceAlso: augmentative and alternative communication, communication deviceThe 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. | Device | Control then Treatment, Treatment then Control |
| ControlAlso: Usual careParticipants 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. | Other | Control then Treatment, Treatment then Control |
Primary outcome
Changes in the frequency of target communicative act related to the patient-defined outcome determined at the beginning of the trial
Time frame: 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.
5 secondary outcomes
Changes in overall communicative acts
Time frame: Baseline, Week 0, Week 6 and Week 12
Changes in parent-reported communication via the Communication Matrix total score
Time frame: Baseline, Week 0, Week 6 and Week 12
Changes in family and caregiver impact assessed via the Family Impact of Assistive Technology Scale for Augmentative and Alternative Communication (FIATS-AAC)
Time frame: Baseline, Week 0, Week 6 and Week 12
Changes in family and caregiver impact assessed via semi-structured interviews
Time frame: Baseline, Week 6 and Week 12
Changes in Language / Communication Competence assessed via the Low-Verbal Investigatory Survey
Time frame: Baseline, Week 0, Week 6 and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 28922953Ganz JB, Morin KL, Foster MJ, Vannest KJ, Genc Tosun D, Gregori EV, Gerow SL. High-technology augmentative and alternative communication for individuals with intellectual and developmental disabilities and complex communication needs: a meta-analysis. Augment Altern Commun. 2017 Dec;33(4):224-238. doi: 10.1080/07434618.2017.1373855. Epub 2017 Sep 19.
- Background: PubMed 12033746Nunn K, Williams K, Ouvrier R. The Australian Childhood Dementia Study. Eur Child Adolesc Psychiatry. 2002 Apr;11(2):63-70. doi: 10.1007/s007870200012.
- Background: PubMed 30952185Light J, McNaughton D. Communicative Competence for Individuals who require Augmentative and Alternative Communication: A New Definition for a New Era of Communication? Augment Altern Commun. 2014 Mar;30(1):1-18. doi: 10.3109/07434618.2014.885080.
- Background: PubMed 37471493Elvidge KL, Christodoulou J, Farrar MA, Tilden D, Maack M, Valeri M, Ellis M, Smith NJC; Childhood Dementia Working Group. The collective burden of childhood dementia: a scoping review. Brain. 2023 Nov 2;146(11):4446-4455. doi: 10.1093/brain/awad242.
- Conditions that cause childhood dementiaLink provided by the sponsor.
- Global research inequity and opportunities for childhood dementiaLink provided by the sponsor.
- Word Health Organisation: Global report on assistive technologyLink provided by the sponsor.
- Rare Voices Australia (RVA) for Australians living with a rare diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The de-identified data set collected for the analysis of this trial will be made available 12 months following analysis and publication of the primary outcome. The following will be made available long-term for use by future researchers from a recognised research institution: * Individual participant data that underlie the results reported after anonymisation/deidentification (text, tables, figures and appendices), * Trial protocol, Participant Information and Consent Form (PICF), * Statistical Analysis Plan (SAP), statistical code. Note that the data sharing of de-identified speech and language data is an Optional Consent for participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech-generating device in people with Genetic Disease and Nonverbal Communication, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela T Morgan (+61 (03) 8341 6458, angela.morgan@mcri.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the frequency of target communicative act related to the patient-defined outcome determined at the beginning of the trial (time frame: Baseline, Week 0, Week 6 and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07039084, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.