NCT07039084

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

A Randomized Cross-over Trial Examining the Efficacy of Implementing a Speech-generating Device for Childhood Dementia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Childhood Dementia
• Genetic Disease
• Nonverbal Communication
• Augmentative and Alternative Communication

Interventions

Type	Name	Description
DEVICE	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	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.

Timeline

• Start date: 2025-11-03
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-06-26
• Last updated: 2025-11-19

Locations

1 site across 1 country: Australia