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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-03

Study Completion Date

2027-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Smart Computing Models, Sensors, and Early Diagnostic Speech and Language Deficiencies Indicators in Child Communication

NCT06633874

Developmental Language Disorders Developmental Articulation Disorder Speech Disorder +1 more

COMPLETED NA

Handheld Technology for Speech Development in Students With Autism

NCT01780090

Autism Spectrum Disorders

COMPLETED NA

The Short-term Verbal Memory Endophenotype for Developmental Language Disorder Language Disorder

NCT06968169

Developmental Language Disorder Healthy Subjects

RECRUITING NA

Addressing Treatment Nonresponders

NCT05921227

Language Development Disorders

NOT_YET_RECRUITING PHASE2

iPad Application to Treat Prosodic Deficits in Students With Communication Disorders

NCT01917864

Autism Communication Disorders

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Dementia Genetic Disease Nonverbal Communication Augmentative and Alternative Communication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

As well as the outcome assessments, research assistants completing coding/rating and integrity/reliability assessments will be blinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment then Control

The arm receives the intervention (device), then the control

Group Type OTHER

Speech-generating device

Intervention Type 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

Intervention Type OTHER

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.

Control then Treatment

The arm receives the control, then the treatment (device)

Group Type OTHER

Speech-generating device

Intervention Type 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

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

augmentative and alternative communication communication device Usual care

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No