RecruitingInterventional

Economic evaluation of the BabblePlay app intervention to support early vocalising in infants with Down syndrome

This research is checking if the BabblePlay app, which helps babies with Down syndrome learn to vocalise, is a sensible use of NHS funds. It's an 'economic study' running alongside a main trial that tests if the app improves language. The aim is to see if the cost of using the app is justified by how it might improve a child's quality of life and development compared to current care. Participants are families in the UK already enrolled in the BabblePlay clinical trial, with babies aged 7–15 months who have Down syndrome and speak English. It involves caregivers completing two online questionnaires about their child's health service use and well-being. This will help decide if the app should be made widely available.

At a glance

Status

Recruiting

Sponsor

University of York

Enrolment target

Start

26 Feb 2026

Estimated completion

31 Mar 2027

Down syndrome

What is this study about?

Babies with Down syndrome often take longer to start making sounds and speaking. The BabblePlay app is a new tool designed to help them make more sounds. When a baby vocalises while using the app, colourful shapes appear on the screen to encourage them.

While another main study is already testing if BabblePlay actually helps with language development, this particular study is focused on something different: whether the app offers 'good value for money'. This is important because the NHS and social services have limited funds, and they need to make sure that any new treatment or tool they introduce is effective and worth the cost. This study compares the cost of using the BabblePlay app with the quality of life improvements it might bring for children, looking at it against the usual care families currently receive.

By understanding both the costs and the benefits in terms of improved well-being, this research will help healthcare decision-makers in the UK decide if they should fund BabblePlay and make it available to more families. This means the study results could influence future care options for babies with Down syndrome.

Key takeaways

This study evaluates if the BabblePlay app is good value for money for children with Down syndrome.
It's for families already participating in the main BabblePlay app trial in the UK.
Participation involves completing two online questionnaires over an 11-month period.
No direct health benefits for participants, but helps inform future NHS decisions.
There are no physical risks, just a small time commitment for caregivers.

Who may be eligible?

This study is specifically for families who are already taking part in the main BabblePlay app study. Your baby must have Down syndrome and be between 7 and 15 months old when they started the main study.

Your family also needs to be based in the UK, and your home should mainly speak English. Your baby should have good enough eyesight to see shapes on a tablet screen. They also shouldn't be involved in another study that looks at speech, language, or communication help.

If your baby meets all these points and is already in the main BabblePlay study, then they can take part in this additional 'value for money' research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your baby already in the main BabblePlay clinical trial?
Does your baby have Down syndrome?
Is your baby between 7 and 15 months old?
Does your family live in the UK and mainly speak English at home?
Can your baby see shapes on a tablet screen well enough?
Is your baby NOT in another speech or language research study?

Answer every question to see your result.

What does participation involve?

This study is done entirely remotely, meaning you won't need to visit any special clinics. If you're already part of the main BabblePlay trial, you'll be asked to complete two online questionnaires at two different times. The first set of questionnaires will be completed when you start this study (this is called 'baseline'), and then you'll complete them again 11 months later.

These questionnaires will ask about your child's use of health and social services (like speech therapy or doctor visits) to help us understand the costs involved. You'll also complete surveys about your child's well-being and development. The total time you'll spend on this study is just the time it takes to fill out these online forms twice over about an 11-month period.

Potential risks and benefits

There are no direct health benefits from taking part in this specific 'value for money' study. However, your involvement will be very important for the NHS and others who make decisions about healthcare, as your answers will help them decide if the BabblePlay app should be available to other families in the future. There are no physical risks involved. The main 'risk' is simply the time it takes to complete the online questionnaires, which is a small amount of extra time for caregivers. You are always free to stop participating in the study at any time without giving a reason, and this will not affect the care your child receives.

Locations (1)

University of York
Approximate
York, England

Common questions

What is the main goal of this study?

The main goal is to see if the BabblePlay app is a good use of healthcare money for babies with Down syndrome.

Do I need to do anything with the app for this study?

No, this study doesn't involve using the app directly. It just asks about your child's health and well-being through online forms.

How long will I be involved in this study?

You'll be asked to complete questionnaires at the beginning and then again 11 months later.

Will my child get special treatment or medicine if we join?

No, this is about evaluating costs and benefits, not providing direct treatment. It's for families already in the main app study.

Who is paying for this research?

The University of York in the UK is funding this study.

How to find out more

Tamar Keren-Portnoy

tamar.keren-portnoy@york.ac.uk +44 (0)1904 323614 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.