Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorChildren's Hospital of Eastern Ontario

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

362 Participants
are divided into 2 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