About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Mindfulness Based Intervention (MBI)
- Cognitive Sham
Treatment groups
Sponsors and collaborators
Children's Hospital of Eastern Ontario
Lead sponsor
The Hospital for Sick Children
Collaborator
Montreal Children's Hospital of the MUHC
Collaborator
University of Ottawa
Collaborator
British Columbia Children's Hospital
Collaborator
Stollery Children's Hospital
Collaborator