[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613926":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":50,"responsibleParty":122,"collaborators":125,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":137,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":48,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":157,"overallStatus":167,"whyStopped":48,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Children's Hospital of Eastern Ontario","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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).",[13],"Behavioral: Mindfulness Based Intervention (MBI)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Behavioral: Cognitive Sham",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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).",[9],[27,28],"MBI","Dawn",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"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.",[15],[34],"Usual Care",[36],{"name":37,"affiliation":38,"role":39},"Andrée-Anne Ledoux, PhD","Children's Hospital of Eastern Ontario Research Institute","PRINCIPAL_INVESTIGATOR",[41,46],{"name":37,"role":42,"phone":43,"phoneExt":44,"email":45},"CONTACT","+1 613-737-7600","4104","aledoux@cheo.on.ca",{"name":47,"role":42,"phone":43,"phoneExt":48,"email":49},"Tyrus Crawford",null,"tcrawford@cheo.on.ca",[51,64,79,94,104],{"facility":52,"status":48,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":48,"geoPoint":48,"contacts":58},"Stollery Children's Hospital","Edmonton","Ontario","T6G 2B7","Canada","CA",[59,62],{"name":60,"role":42,"phone":48,"phoneExt":48,"email":61},"William Craig, MD","wcraig@ualberta.ca",{"name":63,"role":39,"phone":48,"phoneExt":48,"email":48},"William Craig",{"facility":5,"status":48,"city":65,"state":54,"zip":66,"country":56,"countryCode":57,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Ottawa","K1H 8L1",{"type":68,"coordinates":69},"Point",[70,71],-75.69812,45.41117,{"lat":71,"lon":70},[74,75,76,77],{"name":37,"role":42,"phone":43,"phoneExt":44,"email":45},{"name":47,"role":42,"phone":43,"phoneExt":48,"email":49},{"name":37,"role":39,"phone":48,"phoneExt":48,"email":48},{"name":78,"role":39,"phone":48,"phoneExt":48,"email":48},"Roger Zemek, MD",{"facility":80,"status":48,"city":81,"state":54,"zip":82,"country":56,"countryCode":57,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"The Hospital of Sick Children (SickKids)","Toronto","M5G 1X8",{"type":68,"coordinates":84},[85,86],-79.39864,43.70643,{"lat":86,"lon":85},[89,92],{"name":90,"role":42,"phone":48,"phoneExt":48,"email":91},"Adrienne Davis, MD","adrienne.davis@sickkids.ca",{"name":93,"role":39,"phone":48,"phoneExt":48,"email":48},"Andrienne Davis",{"facility":95,"status":48,"city":96,"state":54,"zip":97,"country":56,"countryCode":57,"cosmosGeoPoint":48,"geoPoint":48,"contacts":98},"BC Children's Hospital","Vancouver","V6H 3N1",[99,102],{"name":100,"role":42,"phone":48,"phoneExt":48,"email":101},"Quynh Doan, MD","qdoan@bcchr.ca",{"name":103,"role":39,"phone":48,"phoneExt":48,"email":48},"Quynh Doan",{"facility":105,"status":48,"city":106,"state":48,"zip":107,"country":56,"countryCode":57,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Montreal Children's Hospital","Montreal","H4A3H9",{"type":68,"coordinates":109},[110,111],-73.58781,45.50884,{"lat":111,"lon":110},[114,117,119],{"name":115,"role":42,"phone":48,"phoneExt":48,"email":116},"Isabelle Gagnon, PhD","isabelle.gagnon8@mcgill.ca",{"name":118,"role":39,"phone":48,"phoneExt":48,"email":48},"Isabelle Gagnon",{"name":120,"role":121,"phone":48,"phoneExt":48,"email":48},"Dan Poenaru, MD","SUB_INVESTIGATOR",{"type":39,"investigatorFullName":123,"investigatorTitle":124,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"Andree-Anne Ledoux","Scientist",[126,128,130,132,134],{"name":127,"class":6},"The Hospital for Sick Children",{"name":129,"class":6},"Montreal Children's Hospital of the MUHC",{"name":131,"class":6},"University of Ottawa",{"name":133,"class":6},"British Columbia Children's Hospital",{"name":52,"class":6},"100613926","mindfulness-based-intervention-for-pediatric-mild-traumatic-brain-injury-100613926",false,"NCT07272941","Mindfulness-Based Intervention for Pediatric Mild Traumatic Brain Injury","Multisite Randomized Clinical Trial: Mindfulness-Based Intervention for Mild Traumatic Brain Injury (MBI-4-mTBI)","MBI-4-mTBI","Inclusion Criteria:\n\n* Participants presenting to five PERC EDs after sustaining a direct or indirect head injury\n* Aged 12 through 17.99 years\n* Diagnosed with a definite or suspected concussion, defined by the American College of Rehabilitation Medicine definition\n* Score ≥6 on the 5P rule\n* Suffered the index injury in the previous 48 hours\n* Proficient in English or French\n\nExclusion Criteria:\n\n* Glasgow Coma Scale ≤13\n* Abnormality on standard neuroimaging studies, including positive head CT findings (Note: neuroimaging is not required, but may be performed if clinically indicated)\n* Neurosurgical operative intervention, intubation or intensive care required\n* 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)\n* Severe neurological developmental delay resulting in communication difficulties\n* Intellectual disability\u002Fmental retardation, autism spectrum disorder (history of attention deficit hyperactivity disorder, learning disability, or Tourette's syndrome is not an exclusion)\n* Intoxication at the time of ED presentation as per clinician judgment\n* No clear history of trauma as primary events (e.g., seizure, syncope or migraine)\n* Prior psychiatric hospitalization\n* Prior diagnosis of severe psychiatric disorder such as schizophrenia (diagnosis of anxiety or depression are not exclusionary)\n* Inability to obtain a proper written informed consent\u002Fassent (language barrier, absence of parental authority, developmental delay, intoxication, patient too confused to consent, etc.)\n* Legal guardian not present (certain forms need be completed by parents\u002Flegal guardians)\n* No internet or mobile\u002Ftablet access.\n* Previously enrolled in phase 1 or phase 2 of the feasibility trial or the efficacy trial.","ALL","12 Years","18 Years",{"count":147,"type":148},362,"ESTIMATED","INTERVENTIONAL",[151],"NA","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.",[154,155,156],"Concussions","Mild Traumatic Brain Injury, Concussion","Concussion Mild",[158,159,160,161,162,163,164,165,166],"mild traumatic brain injury","mtbi","concussion","intervention","meditation","quality of life","treatment","Persistent post-concussive symptoms","mindfulness","NOT_YET_RECRUITING","2026-03-17",{"date":170,"type":171},"2026-03-18","ACTUAL",{"date":173,"type":148},"2026-05",{"date":175,"type":148},"2029-12",{"name":5,"class":6},5]