Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury (NCT07272941)
Multisite Randomized Clinical Trial: Mindfulness-Based Intervention for Mild Traumatic Brain Injury (MBI-4-mTBI)
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Stollery Children's Hospital — Edmonton, Ontario
Age range: 12 Years to 18 Years
🧪 Interventions in This Study
- Mindfulness Based Intervention (MBI) (BEHAVIORAL)
- Cognitive Sham (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- Stollery Children's Hospital — Edmonton, Ontario
- Children's Hospital of Eastern Ontario — Ottawa, Ontario
- The Hospital of Sick Children (SickKids) — Toronto, Ontario
- BC Children's Hospital — Vancouver, Ontario
- Montreal Children's Hospital — Montreal,
📞 Contact the Study Coordinator
Phone: (613) 737-7600
Email: aledoux@cheo.on.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.