Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury
Canada362 participantsStarted 2026-05
Plain-language summary
Formal MBIs, such as Mindfulness-Based Stress Reduction (MBSR), have been shown to increase resiliency and teach affect regulation. However, these formal interventions may not be suitable for acutely concussed youth as they are costly, not easily accessible (trained therapists are needed), and require commitment from parents and children for in-person weekly meetings and at-home practice of learned skills for 8 to 16 weeks. Further, MBSR programs may not be readily accessible immediately after a concussion. With the increasing use of mobile phones and tablets in youth, mobile health offers a powerful platform for mental health interventions. Advantages of app-based interventions include constant availability, greater access, tailored content, lower cost, immediate delivery, and increased service capacity and efficiency. Therefore, the anticipated benefit is to show the efficacy of a pragmatic and low-cost intervention and reduce barriers to care through a novel, innovative and accessible MBI treatment program. This will have both a benefit to public health and expand our understanding of the impact of MBIs on pediatric recovery.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants presenting to five PERC EDs after sustaining a direct or indirect head injury
* Aged 12 through 17.99 years
* Diagnosed with a definite or suspected concussion, defined by the American College of Rehabilitation Medicine definition
* Score ≥6 on the 5P rule
* Suffered the index injury in the previous 48 hours
* Proficient in English or French
Exclusion Criteria:
* Glasgow Coma Scale ≤13
* Abnormality on standard neuroimaging studies, including positive head CT findings (Note: neuroimaging is not required, but may be performed if clinically indicated)
* Neurosurgical operative intervention, intubation or intensive care required
* Multi-system injuries with treatment requiring hospital admission, operating room or procedural sedation in ED (Note: hospital admission for observation or management of ongoing concussion symptoms is not an exclusion criteria)
* Severe neurological developmental delay resulting in communication difficulties
* Intellectual disability/mental retardation, autism spectrum disorder (history of attention deficit hyperactivity disorder, learning disability, or Tourette's syndrome is not an exclusion)
* Intoxication at the time of ED presentation as per clinician judgment
* No clear history of trauma as primary events (e.g., seizure, syncope or migraine)
* Prior psychiatric hospitalization
* Prior diagnosis of severe psychiatric disorder such as schizophrenia (diagnosis of anxiety or depression are not exclusionary)
* Ina…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.