[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"concussions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:concussions":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"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":21,"type":22},362,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Concussions","Mild Traumatic Brain Injury, Concussion","Concussion Mild",[32,33,34,35,36,37,38,39,40],"mild traumatic brain injury","mtbi","concussion","intervention","meditation","quality of life","treatment","Persistent post-concussive symptoms","mindfulness","NOT_YET_RECRUITING","2026-03-17",{"date":44,"type":45},"2026-03-18","ACTUAL",{"date":47,"type":22},"2026-05",{"date":49,"type":22},"2029-12",{"name":51,"class":52},"Children's Hospital of Eastern Ontario","OTHER",5,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":17,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":68,"conditions":69,"keywords":70,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":81,"locationsCount":83},"100564056","communities-aligned-to-reduce-concussion-and-head-impact-exposure-100564056","NCT06624202","COmmunities Aligned to Reduce Concussion and Head Impact Exposure","COmmunities Aligned to Reduce Concussion and Head Impact Exposure (COACH)","COACH","Inclusion Criteria:\n\n* Participants without braces\n\nExclusion Criteria:\n\n* Athletes will be excluded from participation if they currently have braces or plan to have braces during the football season, or have dental appliances that may impede the fit of the mouthpiece device (e.g., Herbst Appliance).",true,"11 Years","14 Years",{"count":66,"type":22},880,[25],"Head impacts in collision sports such as football are a public health concern, as repetitive head impacts, even if a concussion is not suspected, have negative effects on brain health. This study has partnered with a community stakeholder group to create a safety program for youth football named \"COmmunities Aligned to reduce Concussion and Head impact exposure (COACH)\", which seeks to improve knowledge and skills of youth coaches in effective and safe practice planning and to change attitudes and beliefs to prevent head impacts and promote safety. To continue advancing COACH as an approach to prevent head injuries in youth football, this R01 Research Project Grant will determine the ability of youth football organizations to adopt COACH and test if COACH is effective in reducing head impacts, concussion, and negative effects of brain health while monitoring how the program is implemented.",[28],[71,72,73],"football injuries","subconcussive head impacts","head impact exposure","RECRUITING","2025-09-03",{"date":77,"type":45},"2025-09-10",{"date":79,"type":45},"2025-05-10",{"date":49,"type":22},{"name":82,"class":52},"Wake Forest University Health Sciences",1]