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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07039084
Registration number
NCT07039084
Ethics application status
Date submitted
18/06/2025
Date registered
26/06/2025
Date last updated
26/06/2025
Titles & IDs
Public title
Using a Speech-Generating Device to Support Communication in Childhood Dementia
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Scientific title
A Randomized Cross-over Trial Examining the Efficacy of Implementing a Speech-generating Device for Childhood Dementia
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Secondary ID [1]
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115839
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Childhood Dementia
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Genetic Disease
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Nonverbal Communication
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Augmentative and Alternative Communication
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Condition category
Condition code
Neurological
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Dementias
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Neurological
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Alzheimer's disease
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Speech-generating device
Other interventions - Control
Other: Treatment then Control - The arm receives the intervention (device), then the control
Other: Control then Treatment - The arm receives the control, then the treatment (device)
Treatment: Devices: 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.
Other interventions: 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.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Changes in the frequency of target communicative act related to the patient-defined outcome determined at the beginning of the trial
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 0, Week 6 and Week 12
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Secondary outcome [1]
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Changes in overall communicative acts
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 0, Week 6 and Week 12
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Secondary outcome [2]
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Changes in parent-reported communication via the Communication Matrix total score
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Assessment method [2]
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Changes in parent-reported communication skills will be measured using the Communication Matrix (Rowland \& Fried-Oken, 2010) 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.
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Timepoint [2]
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Baseline, Week 0, Week 6 and Week 12
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Secondary outcome [3]
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Changes in family and caregiver impact assessed via the Family Impact of Assistive Technology Scale for Augmentative and Alternative Communication (FIATS-AAC)
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Assessment method [3]
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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) (Delarosa et al., 2012). 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.
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Timepoint [3]
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Baseline, Week 0, Week 6 and Week 12
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Secondary outcome [4]
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Changes in family and caregiver impact assessed via semi-structured interviews
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Week 6 and Week 12
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Secondary outcome [5]
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Changes in Language / Communication Competence assessed via the Low-Verbal Investigatory Survey
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Assessment method [5]
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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) (Naples et al., 2022). 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.
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Timepoint [5]
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Baseline, Week 0, Week 6 and Week 12
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Eligibility
Key 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)
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Minimum age
3
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Maximum age
12
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Crossover
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2027
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Actual
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Sample size
Target
38
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Murdoch Children's Research Institute - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Individuals with childhood dementia experience loss of developmental skills and 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 childhood dementia. 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.
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Trial website
https://clinicaltrials.gov/study/NCT07039084
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Trial related presentations / 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. Nunn K, Williams K, Ouvrier R. The Australian Childhood Dementia Study. Eur Child Adolesc Psychiatry. 2002 Apr;11(2):63-70. doi: 10.1007/s007870200012. Light 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. Elvidge 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.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Angela T Morgan
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Address
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Country
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Phone
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+61 (03) 8341 6458
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Analytic code
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When will data be available (start and end dates)?
12 months after publication of primary outcome
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Available to whom?
Interested researchers may request access to the data by submitting a formal data sharing request to the Sponsor. The request will be reviewed by the Sponsor and the Sponsor-Investigator, and any relevant Murdoch Children's Research Institute (MCRI) data sharing committee, considering factors such as scientific merit, data security, and adherence to the approved research objectives. The data may be obtained from MCRI by emailing
[email protected]
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07039084
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