ConcussionsMBI-4-mTBINCT07272941
Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury
A study testing Mindfulness Based Intervention (MBI) in people with Concussions and Mild Traumatic Brain Injury, Concussion, run by Children's Hospital of Eastern Ontario at 5 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Concussions, Mild Traumatic Brain Injury, Concussion, Concussion Mild
- What is being tested?
- Mindfulness Based Intervention (MBI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- 5 sitesCanada
- Study dates
- May 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
- 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)
Show all 14Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites
Stollery Children's Hospital
Edmonton, Ontario, T6G 2B7
William Craig, MD, wcraig@ualberta.ca
William Craig
Montreal Children's Hospital
Montreal, H4A3H9
Isabelle Gagnon, PhD, isabelle.gagnon8@mcgill.ca
Isabelle Gagnon
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Andrée-Anne Ledoux, PhD, +1 613-737-7600 ext. 4104, aledoux@cheo.on.ca
Tyrus Crawford, +1 613-737-7600, tcrawford@cheo.on.ca
The Hospital of Sick Children (SickKids)
Toronto, Ontario, M5G 1X8
Adrienne Davis, MD, adrienne.davis@sickkids.ca
Andrienne Davis
BC Children's Hospital
Vancouver, Ontario, V6H 3N1
Quynh Doan, MD, qdoan@bcchr.ca
Quynh Doan
About this study
Official title: Multisite Randomized Clinical Trial: Mindfulness-Based Intervention for Mild Traumatic Brain Injury (MBI-4-mTBI)
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.
Read the 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.
- Being tested
- Mindfulness Based Intervention (MBI), Cognitive Sham
- Keywords
- mild traumatic brain injury, mtbi, concussion, intervention, meditation, quality of life, treatment, Persistent post-concussive symptoms, mindfulness
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Intervention (MBI)Behavioural
Also called MBI, Dawn
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 ShamBehavioural
Also called Usual Care
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Intervention + Usual Care | Experimental | 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). Receives: Behavioral: Mindfulness Based Intervention (MBI) |
| Cognitive Sham + Usual care | Sham comparator | 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. Receives: Behavioral: Cognitive Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Quality of Life Inventory™ version 4.0
The PedsQL is a reliable and valid measure of quality of life (QoL) in healthy children and adolescents and those with acute and/or chronic health conditions. Parent versions exist for children aged 2 to 18 years (in 4 age groups) and child versions for those aged 5 and over. For this study, only the child's version (ages 8-12 and ages 13-18) will be used. The inventory covers four domains: physical, emotional, social, and school, the sum of which is total QoL. This measure will be used to assess whether early brief MBI can improve total QoL. Higher scores indicate better health related to QoL.
Measured: Day of enrolment (ED), Week 4, Week 8
Secondary outcomes (12)
Connor-Davidson Resilience Scale-10 (CD-RISC)
A Validated measure offered in both English and French for the adolescent concussion population that assesses the individual's own perception of hardiness or perceived stress. It is a 10-item rating scale, 5-point Likert scale; the scale is summed and provides a total score (0-40) for the level of resilience. A lower score is attributed to lesser levels of resilience.
Measured: Day 1, Week 4, & Week 8
The 18-item PedsQL™ Multidimensional Fatigue Scale (PedsQL-MFS)
Designed to measure fatigue in pediatric patients and comprises the General Fatigue Scale (6 items), Sleep-Rest Fatigue Scale (6 items), and Cognitive Fatigue Scale (6 items). The PedsQL™ Multidimensional Fatigue Scale has demonstrated excellent internal consistency, reliability and validity. For this study, only the child's version (ages 8-12 and ages 13-18) will be used. Higher scores are associated with less fatigue.
Measured: Day 1, Week 4, & Week 8
Health and Behaviour Inventory (HBI)
This assessment will be used to measure the degree of symptoms, available in both English and French. The HBI is a 20-item self-report questionnaire, Likert scale (0, 1, 2, or 3 points) yielding separate scores for cognitive and somatic symptom scales for a total score range of 0 to 60. Higher scores indicate a higher degree of symptoms. Participants will complete a post-injury measure, while parents will complete a retrospective (pre-injury) measure at an emergency department presentation. Only participants will complete HBI measures at follow-up.
Measured: Day of enrolment (ED; retrospective (parents) and post-injury (participant)), Week 2, Week 4, & Week 8
The General Anxiety Disorder 7-items (GAD-7)
The GAD-7 is a validated, reliable and sensitive to treatment-related changes tool that assesses anxiety symptoms in youth. It is a 7-item scale, 3-point Likert scale, providing a sum score (0-21) of the level of GAD. A higher score indicates a worse outcome. It is available for participants in both English and French.
Measured: Day of enrolment (ED), Week 4, & Week 8
Center for Epidemiologic Studies Short Depression Scale (CES-D-10)
The CES-D-10 is a 10-item questionnaire assessing how individuals feel during the past week. This is a short version of the 20-item CES-D tool. Graded on a 4-point Likert scale, with items 5 and 8 scored inversely. The final score is the sum of the graded items with higher scores indicating a worse outcome. The CES-D-10 has good internal consistency (Cronbach's α=0.86) and test-retest reliability (I CC=0.85). It is also available in both English and French.
Measured: Day of enrollment (ED), Week 4, & Week 8
Child and Adolescent Mindfulness Measure (CAMM)
The CAMM is a 10-item validated self-report measure of mindfulness for use with children and adolescents, in both English and French. Responses are scored on a 5-point Likert scale. Lower scores indicate higher tendencies to be mindful in everyday life.
Measured: Day 1, Week 4, & Week 8
Pediatric Fear Avoidance Behavior After Traumatic Brain Injury (PFAB-TBI)
The Pediatric Fear Avoidance Behavior After Traumatic Brain Injury (PFAB-TBI) is a validated measure used in the pediatric population with concussion to measure the degree of fear avoidance as a negative coping style post-injury. It is comprised of 16-item, 4-point Likert scale asking participants to agree with statements that range from 0 ("strongly disagree") through 3 ("strongly agree"). The total item score is out of 48 with higher scores associated with more negative clinical outcomes.(Cairncross et al., 2021). This measure is offered in both English and French.
Measured: Week 4 & Week 8
Avoidance and Fusion Questionnaire for Youth Short Form (AFQ-Y8)
The AFQ-Y8 is the 8-item short-form version of the original 17-item AFQ-Y, a self-report measure examining psychological inflexibility in youth. This validated measure comprises two constructs of psychological inflexibility: cognitive fusion (the belief that inner thoughts are true and allow them to dominate behaviour) and experiential avoidance (avoidance or suppression of unwanted internal experiences). Participants are asked to agree with statements on a 5-point Likert scale with responsed from not true at all (0) to very true (4). Items are summed to produce a final score between 0 and 32, with a higher score indicating greater psychological inflexibility. Measures are available in both English and French.
Measured: Day 1, Week 4 & Week 8
Perceived Stress Scale (PSS-10)
A 10-item self-report questionnaire examining an individual's perception of stress. The items are ranked on a 5-point Likert scale, asking participants to respond from Never (1) to very often (5). Items 4, 5 and 7 are positively worded and reverse-scored, then all items are summed. Higher scores indicate that participants are more likely to appraise events as stressful. Participants also have the option to complete the measure in English or French.
Measured: Day of enrollment (ED), Week 4, & Week 8
Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
A validated 10-item questionnaire used in adolescent populations to measure emotion regulation. The measure consists of 2 subcategories: cognitive reappraisal (6 items) and expressive suppression (4 items). . Responses to items include a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Composite scores for cognitive reappraisal range from 6-30 and 4 to 20 for expressive suppression. Scores are typically interpreted separately. Higher reappraisal scores are associated with positive tendencies to reframe situations to regulate emotions, while higher repressive scores are negatively associated with the tendency to inhibit emotions. This measure can be completed in English of French.
Measured: Day 1, Week 4, & Week 8
Credibility Score (Credibility and Expectancy Questionnaire (CEQ))
The CEQ is a 6-item questionnaire (9-point Likert scale) assessing credibility and expectancy. The validated questionnaire demonstrates excellent reliability across different populations and is available in both English and French. A higher score indicates more credibility.
Measured: Week 1
Modified version of the Client Satisfaction Questionnaire (CSQ)
This is a validated, reliable, 8-item questionnaire used to measure client satisfaction with a particular program or service. In this case, the questionnaire has been modified to assess participant satisfaction with the app-based intervention. It is available to participants in English or French.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study startMay 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic-blind randomized clinical trial with two two groups who will be studied: (1) experimental group: usual care plus early introduction of the app-based MBI; and (2) a delayed-start (crossover) control group: usual care plus early introduction sham application, including the cognitive math game called 2048, with option to receive experimental app-based MBI after 4 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, Montreal Children's Hospital of the MUHC, University of Ottawa, British Columbia Children's Hospital, Stollery Children's Hospital
- Responsible party
- Principal investigator, Andree-Anne Ledoux, Children's Hospital of Eastern Ontario
- Investigators
- Andrée-Anne Ledoux, PhD, Principal investigator, Children's Hospital of Eastern Ontario Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272941
- Sponsor's protocol ID
- 516950
- Other IDs
- 516950
- Acronym
- MBI-4-mTBI
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the study protocol and statistical analysis plan.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Randomized Clinical Trial: Mindfulness-Based Intervention for Mild Traumatic Brain Injury (MBI-4-mTBI)
- ClinicalTrials.gov ID
- NCT07272941
- Acronym / sponsor ID
- MBI-4-mTBI / 516950
- Keywords
- mild traumatic brain injury, mtbi, concussion, intervention, meditation, quality of life, treatment, Persistent post-concussive symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, Montreal Children's Hospital of the MUHC, University of Ottawa, British Columbia Children's Hospital, Stollery Children's Hospital
- Study start
- May 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic-blind randomized clinical trial with two two groups who will be studied: (1) experimental group: usual care plus early introduction of the app-based MBI; and (2) a delayed-start (crossover) control group: usual care plus early introduction sham application, including the cognitive math game called 2048, with option to receive experimental app-based MBI after 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Intervention + Usual Care | Experimental | Behavioral: Mindfulness Based Intervention (MBI)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). |
| Cognitive Sham + Usual care | Sham comparator | Behavioral: Cognitive ShamUsual 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
- Severe neurological developmental delay resulting in communication difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Intervention (MBI)Also: MBI, DawnUsing 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). | Behavioural | Mindfulness Intervention + Usual Care |
| Cognitive ShamAlso: Usual CareUsual 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. | Behavioural | Cognitive Sham + Usual care |
Primary outcome
Pediatric Quality of Life Inventory™ version 4.0
Time frame: Day of enrolment (ED), Week 4, Week 8
The PedsQL is a reliable and valid measure of quality of life (QoL) in healthy children and adolescents and those with acute and/or chronic health conditions. Parent versions exist for children aged 2 to 18 years (in 4 age groups) and child versions for those aged 5 and over. For this study, only the child's version (ages 8-12 and ages 13-18) will be used. The inventory covers four domains: physical, emotional, social, and school, the sum of which is total QoL. This measure will be used to assess whether early brief MBI can improve total QoL. Higher scores indicate better health related to QoL.
12 secondary outcomes
Connor-Davidson Resilience Scale-10 (CD-RISC)
Time frame: Day 1, Week 4, & Week 8
The 18-item PedsQL™ Multidimensional Fatigue Scale (PedsQL-MFS)
Time frame: Day 1, Week 4, & Week 8
Health and Behaviour Inventory (HBI)
Time frame: Day of enrolment (ED; retrospective (parents) and post-injury (participant)), Week 2, Week 4, & Week 8
The General Anxiety Disorder 7-items (GAD-7)
Time frame: Day of enrolment (ED), Week 4, & Week 8
Center for Epidemiologic Studies Short Depression Scale (CES-D-10)
Time frame: Day of enrollment (ED), Week 4, & Week 8
Child and Adolescent Mindfulness Measure (CAMM)
Time frame: Day 1, Week 4, & Week 8
Pediatric Fear Avoidance Behavior After Traumatic Brain Injury (PFAB-TBI)
Time frame: Week 4 & Week 8
Avoidance and Fusion Questionnaire for Youth Short Form (AFQ-Y8)
Time frame: Day 1, Week 4 & Week 8
Perceived Stress Scale (PSS-10)
Time frame: Day of enrollment (ED), Week 4, & Week 8
Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
Time frame: Day 1, Week 4, & Week 8
Credibility Score (Credibility and Expectancy Questionnaire (CEQ))
Time frame: Week 1
Modified version of the Client Satisfaction Questionnaire (CSQ)
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Yes. We plan to share the study protocol and statistical analysis plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrée-Anne Ledoux, PhD principal investigator
Children's Hospital of Eastern Ontario Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Intervention (MBI) in people with Concussions and Mild Traumatic Brain Injury, Concussion, run by Children's Hospital of Eastern Ontario at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrée-Anne Ledoux, PhD (+1 613-737-7600 ext. 4104, aledoux@cheo.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Quality of Life Inventory™ version 4.0 (time frame: Day of enrolment (ED), Week 4, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.