Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury

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.

Conditions

• Concussions
• Mild Traumatic Brain Injury, Concussion
• Concussion Mild

Interventions

BEHAVIORAL

Mindfulness Based Intervention (MBI)

Using the Dawn MBI-based app, targeted MBI training will consist of a 4-to-8-week custom-made program that includes audio-recorded lectures, guided meditations such as walking meditations and body scans, setting intentions and check-in with mood, and writing events journal. Each standardized course is unlocked as the participant progresses through the MBI program. Participants will be encouraged to engage in the app-based activities for at least 10 minutes every day, with a minimum of 4 days per week, over a period of 4 weeks (with option to continue for 8 weeks).

BEHAVIORAL

Cognitive Sham

Usual care recommends that the patient refrain from physical and cognitive activities for 24-48 hours after injury. After the rest period, it is recommended that low to moderate levels of physical and cognitive activity be gradually started 24-48 hours after injury. The activities should be performed at a level that does not result in recurrence or exacerbation of symptoms. Children must refrain from any activities that increase the risk of re-injury (drills with body contact or that risk falls) until fully asymptomatic and cleared by their primary care or other medical provider. The sham journey will consist of playing an open-source cognitive math game (called "2048") delivered through the same app as MBI, but without the mindfulness content. Participants will be encouraged to utilize the app for at least 10 minutes every day, with a minimum of 4 days a week, over a period of 4 weeks.

Sponsors & Collaborators

• The Hospital for Sick Children

  collaborator OTHER

• Montreal Children's Hospital of the MUHC

  collaborator OTHER

• University of Ottawa

  collaborator OTHER

• British Columbia Children's Hospital

  collaborator OTHER

• Stollery Children's Hospital

  collaborator OTHER

• Children's Hospital of Eastern Ontario

  lead OTHER

Principal Investigators

• Andrée-Anne Ledoux, PhD · Children's Hospital of Eastern Ontario Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2029-05-31

Completion

2029-12-31

Countries

• Canada

Study Locations