Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury

NCT ID: NCT07272941

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2029-12-31

Brief 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.

Detailed Description

The proposed study has two groups: (1) experimental group: usual care plus early introduction of the app-based MBI; and (2) control group: usual care plus early introduction sham application, including the cognitive math game called 2048. Usual care in both groups refers to the recommended return to physical and cognitive activity 24-48 hours post-injury. To maintain valid results, participants will be "blinded" to their intervention. (i.e., during the informed consent process, the study will be referred to as the App-based Intervention study with the purpose of evaluating two app-based interventions). Although only one group will receive the MBI intervention, both groups will be receiving usual care instructions, which involves the early return to cognitive and physical activities. Therefore, both groups will be receiving a beneficial intervention with the experimental group receiving the additional MBI that is being assessed. For both groups, Treatment Coaches will be assigned to each participant. Coaches will maintain regular communication with patients. Their role will be to encourage and assist participants throughout the study duration through a standardized question-and-answer protocol. Additionally, to increase adherence to the intervention, participants will complete a motivational interview at 2 weeks. After 4 weeks, all participants will be offered the MBI program for an extra period of 4 weeks. The control group will have the possibility at that time to crossover and start the intervention if desired.

Conditions

Concussions; Mild Traumatic Brain Injury, Concussion; Concussion Mild

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Mindfulness Intervention + Usual Care

Experimental group: MBI training will consist of a 4-week custom-made program that includes setting intentions and check-in with mood, audio-recorded lectures, guided meditations such as body scans, and writing events journal. Each standardized course will be unlocked as the participant progresses through the program. Users will be encouraged to participate in the app-based activities for a total of 10-15 minutes every day, with a minimum of 4 days a week, over a period of 4 weeks (with the option to continue for 8 weeks).

Group Type: EXPERIMENTAL

Mindfulness Based Intervention (MBI)

Intervention Type: BEHAVIORAL

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).

Cognitive Sham + Usual care

Usual care recommends that patients refrain from physical and cognitive activities for 24-48 hours after concussion. After the initial rest period, it is recommended to introduce low to moderate levels of physical and cognitive activity at a level that does not result in recurrence or exacerbation of symptoms. Patients must refrain from any activities that increase the risk of re-injury (body contact or risk falls) until fully asymptomatic and cleared by their primary care or other medical provider. This arm is considered as active participant with the sham app (cognitive math game called "2048") delivered via the same app as the MBI, but without the mindfulness content. Participants will be encouraged to engage in the app-based activities for at least 10 minutes daily, with a minimum of 4 days per week, over a period of 4 weeks. Participants will also be asked questions about their stress, emotions, and symptoms.

Group Type: SHAM_COMPARATOR

Cognitive Sham

Intervention Type: BEHAVIORAL

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MBI; Dawn; Usual Care

Eligibility Criteria

Inclusion Criteria

• 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
• Suffered the index injury in the previous 48 hours
• Proficient in English or French

Exclusion Criteria

• 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
• Severe neurological developmental delay resulting in communication difficulties
• Intellectual disability/mental retardation, autism spectrum disorder (history of attention deficit hyperactivity disorder, learning disability, or Tourette's syndrome is not an exclusion)
• Intoxication at the time of ED presentation as per clinician judgment
• No clear history of trauma as primary events (e.g., seizure, syncope or migraine)
• Prior psychiatric hospitalization
• Prior diagnosis of severe psychiatric disorder such as schizophrenia (diagnosis of anxiety or depression are not exclusionary)
• Inability to obtain a proper written informed consent/assent (language barrier, absence of parental authority, developmental delay, intoxication, patient too confused to consent, etc.)
• Legal guardian not present (certain forms need be completed by parents/legal guardians)
• No internet or mobile/tablet access.
• Previously enrolled in phase 1 or phase 2 of the feasibility trial or the efficacy trial.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: collaborator

Montreal Children's Hospital of the MUHC

OTHER

Sponsor Role: collaborator

University of Ottawa

OTHER

Sponsor Role: collaborator

British Columbia Children's Hospital

OTHER

Sponsor Role: collaborator

Stollery Children's Hospital

OTHER

Sponsor Role: collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: lead

Responsible Party

Andree-Anne Ledoux

Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrée-Anne Ledoux, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Eastern Ontario Research Institute

Locations

Stollery Children's Hospital

Edmonton, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

The Hospital of Sick Children (SickKids)

Toronto, Ontario, Canada

BC Children's Hospital

Vancouver, Ontario, Canada

Montreal Children's Hospital

Montreal, , Canada

Countries

Canada

Central Contacts

Andrée-Anne Ledoux, PhD

Role: CONTACT

aledoux@cheo.on.ca

+1 613-737-7600 ext. 4104

Tyrus Crawford

Role: CONTACT

tcrawford@cheo.on.ca

+1 613-737-7600

Facility Contacts

William Craig, MD

Role: primary

wcraig@ualberta.ca

Andrée-Anne Ledoux, PhD

Role: primary

aledoux@cheo.on.ca

+1 613-737-7600 ext. 4104

Tyrus Crawford

Role: backup

tcrawford@cheo.on.ca

+1 613-737-7600

Adrienne Davis, MD

Role: primary

adrienne.davis@sickkids.ca

Quynh Doan, MD

Role: primary

qdoan@bcchr.ca

Isabelle Gagnon, PhD

Role: primary

isabelle.gagnon8@mcgill.ca

Other Identifiers

516950

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

516950

Identifier Type: -

Identifier Source: org_study_id