CHEO RI Publishes First Digital Therapeutic Study for Pediatric Concussion; Secure Health Canada Authorization for Pivotal Trial with Mobio Interactive
CHEO RI Publishes First Digital Therapeutic Study for Pediatric Concussion; Secure Health Canada Authorization for Pivotal Trial with Mobio Interactive
FOR IMMEDIATE RELEASE
OTTAWA, ON and SINGAPORE — May 13, 2026 — The Children’s Hospital of Eastern Ontario (CHEO) Research Institute, today announced the publication of the first digital therapeutic (DTx) trial specifically for adolescents recovering from concussion. The study, published in JMIR Rehabilitation and Assistive Technologies, validates the feasibility of using an app-delivered, mindfulness-based intervention (MBI) to manage persisting symptoms in youth.
The Clinical Gap
Approximately one-in-three children develop persisting symptoms after a concussion (PSAC), characterized by physical, cognitive, emotional, and sleep disturbances that last beyond four weeks. While injury-specific factors diminish over time, premorbid and psychological factors—such as distress, anxiety, and maladaptive coping—remain strong predictors of a prolonged recovery. Traditional in-person interventions are often costly and inaccessible. This trial evaluated a scalable alternative delivered via Mobio’s clinical platform, Dawn (formerly AmDTx).
The Feasibility Data
The Health Canada-regulated, parallel-group feasibility RCT enrolled 99 adolescents aged 12 to 18 within seven days of a physician-diagnosed concussion. Key performance benchmarks from the study include:
Retention: 90% of participants completed the four-week outcomes, demonstrating high commitment and follow-up strategy viability.
Recruitment: 80% of eligible participants consented to randomization, exceeding the 50% benchmark.
Credibility: 75% of participants scored above the scale midpoint, confirming high intervention acceptability.
Safety: Zero adverse events related to the intervention were reported.
Adherence: 60% of participants met the minimal activity requirements. While landing in the "amber zone," this provides a clear baseline for UX refinements to bolster engagement during weeks two and three post-injury.
The Path to Efficacy: Pivotal Multisite RCT
Building on these feasibility markers, Mobio Interactive has obtained a Class II Investigational Testing Authorization (ITA) from Health Canada (Application No. 402086) to initiate a full-scale efficacy trial. This multisite randomized clinical trial will enroll 362 patients across Canada’s leading pediatric institutions:
- Children’s Hospital of Eastern Ontario (CHEO)
- The Hospital for Sick Children (SickKids)
- BC Children’s Hospital
- Stollery Children’s Hospital
- Montreal Children’s Hospital
The trial will investigate total quality of life differences at four weeks, comparing the Dawn intervention ("pCARE") against a current standard of care intervention.
Strategic Significance
"This research highlights the transition from clinical exploration to the delivery of precision psychiatry for a large patient base that needs it," said Dr. Bechara Saab, CEO and Chief Scientist at Mobio Interactive. "CHEO RI continues to be a powerful co-developed and validation partner for this exciting iteration in scaleable, personalised patient care".
About the CHEO Research Institute
The CHEO Research Institute is a pediatric research organization located in Ottawa, Canada, committed to "discoveries today for healthier kids tomorrow". The Institute hosts a specialised Clinical Research Unit that provides integrated services for database development, data validation, and the management of multi-site clinical trials. As a leading member of the Pediatric Emergency Research Canada (PERC) network, CHEO RI has an established history of executing large-scale clinical studies and translating research findings into provincial, national, and international pediatric care guidelines
About Mobio Interactive
Mobio Interactive is a digital health company that develops software-based interventions to improve mental health. Its flagship platform, Dawn, uses computer vision and deep neural networks to objectively quantify stress from 30-second selfie videos with >86% accuracy.
Contact:
mi@mobiointeractive.com