Using a Speech-Generating Device to Support Communication in Childhood Dementia

Not Applicable

Not yet recruiting

• Conditions: Childhood Dementia; Genetic Disease; Nonverbal Communication; Augmentative and Alternative Communication

• Registration Number: NCT07039084
• Lead Sponsor: Murdoch Childrens Research Institute

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.

Detailed Description

The umbrella term 'childhood dementia' describes the hundreds of rare neurodegenerative genetic disorders occurring in children. Individuals with childhood dementia experience loss of developmental skills - many children have limited verbal speech to begin with but continue to lose their ability to communicate as the disease progresses. Augmentative and alternative communication (AAC) is one of the ways to support children with little speech and children with childhood dementia should have access to such tools as early as possible. However, the efficacy of high-tech AAC methods, such as speech generating devices, for children with childhood dementia has not been rigorously examined.

In this randomised cross-over trial, 38 participants with childhood dementia 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 for communication in childhood dementia 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 Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-01
• Primary Completion: 2027-05
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 38

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)

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Changes in overall communicative acts	Baseline, Week 0, Week 6 and Week 12	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.
Changes in parent-reported communication via the Communication Matrix total score	Baseline, Week 0, Week 6 and Week 12	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.
Changes in family and caregiver impact assessed via the Family Impact of Assistive Technology Scale for Augmentative and Alternative Communication (FIATS-AAC)	Baseline, Week 0, Week 6 and Week 12	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.
Changes in family and caregiver impact assessed via semi-structured interviews	Baseline, Week 6 and Week 12	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.
Changes in Language / Communication Competence assessed via the Low-Verbal Investigatory Survey	Baseline, Week 0, Week 6 and Week 12	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.

Trial Locations

Locations (1)

Murdoch Children's Research Institute; 🇦🇺 Melbourne, Victoria, Australia