Not yet recruitingNAINTERVENTIONAL

Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury

This study is for young people aged 12 to 18 who have recently had a mild head injury, also known as a concussion. It's investigating whether using a special mindfulness app can help them recover better and more quickly. The app teaches techniques to manage stress and feelings, which can be particularly helpful after a head injury. Participants will be split into two groups: one uses the mindfulness app, and the other uses a brain-training game app. Both groups will also receive standard care advice for concussions. The aim is to see if this easy-to-access, low-cost app can make a real difference in how young people cope and recover after a concussion, making support more widely available.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Children's Hospital of Eastern Ontario

Enrolment target

362

Start

01 May 2026

Estimated completion

01 Dec 2029

Concussions Mild Traumatic Brain Injury, Concussion Concussion Mild

What is this study about?

This research study is looking into new ways to help young people aged 12 to 18 who have recently had a mild head injury, often called a concussion. When someone has a concussion, they might experience symptoms like headaches, dizziness, or difficulty concentrating, and sometimes struggle with their feelings. Standard medical advice suggests a short period of rest followed by a gradual return to normal activities. This study wants to see if adding a special support program, delivered through a mobile app, can further improve recovery.

The app being tested teaches 'mindfulness'. Mindfulness involves paying close attention to the present moment, your thoughts, feelings, and body sensations, which can help you manage stress and emotions. Traditionally, mindfulness programs require many in-person sessions, which can be hard to attend, expensive, and not always available. This study wants to find out if an app version, which is much easier to access and use from home, can be just as helpful for young people recovering from a concussion.

The study aims to see if this app can help young people feel better, cope more effectively, and reduce problems that can sometimes linger after a concussion. It’s hoping to show that such an app could be a simple, affordable, and readily available tool to support recovery, benefiting many young people and their families across the UK. By making support easily accessible, the study could open up new ways to help young people get back to their best after an injury.

Key takeaways

This study tests a mindfulness app for young people (12-18) with recent concussions.
It aims to make recovery support more accessible and affordable.
Participants use either a mindfulness app or a brain-game app for 4 weeks.
A 'Treatment Coach' provides remote support and connection.
All participants eventually get access to the mindfulness program.
No extra hospital visits are required; all support is app-based and remote.

Who may be eligible?

This study is looking for young people between 12 and 18 years old who have recently had a mild head injury (concussion). You would need to have seen a doctor in an emergency department for your head injury and had the injury within the last 48 hours. It's important that you understand English or French well enough to take part.

There are certain reasons why you might not be able to join. For example, if your head injury was very severe and required intensive care, surgery, or showed serious problems on a brain scan, or if you had other major injuries. Also, if you have certain existing conditions like severe learning difficulties, a diagnosis of schizophrenia, or issues that make it difficult to communicate or give your permission to join, you wouldn't be able to participate. You also need to have internet access and a mobile phone or tablet to use the app.

Keep in mind that if you've already taken part in previous versions of this specific study, you won't be able to join again. The medical team at the emergency department will help figure out if you meet all the requirements for the study.

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.

Are you between 12 and 18 years old?
Did you have a head injury (concussion) within the last 48 hours?
Can you understand English or French well?
Do you have a smartphone or tablet with internet access?
Do you *not* have a severe pre-existing brain condition or other serious injuries?
Have you *not* joined this specific study before?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be part of it for about 4 weeks. You'll be assigned to one of two groups: one group will use a mindfulness app, and the other will use a general brain-training game app (like '2048'). Both apps will be used alongside the usual care advice for concussions, which includes gradually returning to physical and mental activities 24-48 hours after your injury. Both you and your parents/guardians will know that you are taking part in a study testing two different apps, but neither you nor the study team will know which specific app (mindfulness or game) you're using until later to keep the results fair.

A 'Treatment Coach' will be assigned to you. This coach will regularly check in with you, answer your questions, and offer support throughout the study using a set of standard questions. After 2 weeks, you'll have a special chat with your coach to help keep you motivated to use the app. After the initial 4 weeks, everyone in the study will be offered the mindfulness app for an additional 4 weeks. If you were in the brain-training game group, you'll have the chance to try the mindfulness app at that point if you wish. There are no in-person follow-up visits beyond your initial emergency department visit where you might join the study.

Potential risks and benefits

Taking part in this study could offer several potential benefits. While we don't know for sure if the mindfulness app will help, it might provide tools and techniques to manage stress, improve emotional well-being, and potentially aid your recovery from a concussion earlier than usual, and it's delivered in a convenient, accessible way. Both groups will also receive usual care advice. There are very few direct risks associated with using a mobile app. However, some people might find mindfulness exercises challenging at first, or using the app could take up some time each day. All participants have the right to leave the study at any time, for any reason, without it affecting their medical care.

Locations (5)

Stollery Children's Hospital
Approximate
Edmonton, Canada
Children's Hospital of Eastern Ontario
Verified postcode
Ottawa, Canada
The Hospital of Sick Children (SickKids)
Verified postcode
Toronto, Canada
BC Children's Hospital
Approximate
Vancouver, Canada
Montreal Children's Hospital
Verified postcode
Montreal, Canada

Common questions

What is a 'mild traumatic brain injury'?

It's another medical term for a concussion, which is a mild head injury that can affect how your brain works for a short time.

What is 'mindfulness'?

Mindfulness is a practice where you learn to focus on the present moment, noticing your thoughts and feelings without judgment. It can help you feel calmer and manage stress.

Will I know if I'm using the 'real' mindfulness app or the game app?

No, during the main part of the study, neither you nor the doctors will know which app you're using. This helps make the study fair, but eventually, everyone will get the chance to use the mindfulness app.

How long will I be in the study?

The main part of the study lasts 4 weeks, with an option to continue with the mindfulness app for another 4 weeks afterwards.

Do I need to go to many hospital appointments for this study?

No, you don't need extra hospital visits. Your coach will communicate with you remotely, and you use the app at home.

How to find out more

Andrée-Anne Ledoux, PhD

aledoux@cheo.on.ca +1 613-737-7600 Official trial record

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