[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544564":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":173,"collaborators":175,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":181,"sex":187,"minAge":188,"maxAge":189,"enrollmentInfo":190,"targetDuration":10,"studyType":193,"phases":10,"briefSummary":194,"conditions":195,"keywords":206,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},{"fullName":5,"class":6},"University of California, Davis","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Derivation Cohort",null,"Four sites will enroll a derivation cohort (n=1512) of head-injured children. Qualified participants will complete or be evaluated with validated questionnaires. Data related to the mTBI event and the participants medical history will be recorded.",[13,14,15],"Behavioral: Validated Questionnaires","Behavioral: Questionnaires","Other: Clinician \u002F Medical Record Variables",{"label":17,"type":10,"description":18,"interventionNames":19},"Validation Cohort","Three sites will enroll a validation cohort (n=1080) of head-injured children. Qualified participants will complete or be evaluated with validated questionnaires. Data related to the mTBI event and the participants medical history will be recorded.",[13,14,15],[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"BEHAVIORAL","Validated Questionnaires","Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-8 (PHQ-8), The Rivermead Post Concussion Symptom Questionnaire (Rivermead), Pediatric Quality of Life Inventory (PedsQL), Strengths and Difficulties Questionnaire (SDQ)",[9,17],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"Questionnaires","Early Physical Activity\u002FReturn to School Questionnaire, Mental Health Utilization Questionnaire",[9,17],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Clinician \u002F Medical Record Variables","Medical History, Emergency Department Clinical Variables",[9,17],[35],{"name":36,"affiliation":5,"role":37},"Daniel K Nishijima, MD, MAS","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":10,"email":42},"CONTACT","916-734-3884","dnishijima@health.ucdavis.edu",{"name":44,"role":40,"phone":45,"phoneExt":10,"email":46},"Nathan Kuppermann, MD, MPH","916-734-1535","nkuppermann@health.ucdavis.edu",[48,72,93,113,134,153],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University of California, Davis Medical Center","RECRUITING","Sacramento","California","95817","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-121.4944,38.58157,{"lat":60,"lon":59},[63,67,71],{"name":64,"role":40,"phone":65,"phoneExt":10,"email":66},"Maria Marois, PhD, MPH","916-734-0373","mtmarois@health.ucdavis.edu",{"name":68,"role":40,"phone":69,"phoneExt":10,"email":70},"Kyle Pimenta, BAS","916-734-8847","kpimenta@health.ucdavis.edu",{"name":36,"role":37,"phone":10,"phoneExt":10,"email":10},{"facility":73,"status":50,"city":74,"state":75,"zip":76,"country":54,"countryCode":55,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":57,"coordinates":78},[79,80],-75.16362,39.95238,{"lat":80,"lon":79},[83,87,91],{"name":84,"role":40,"phone":85,"phoneExt":10,"email":86},"Daniel Corwin, MD","215-327-2306","corwind@chop.edu",{"name":88,"role":40,"phone":89,"phoneExt":10,"email":90},"Melissa Godfrey, MPH","302-598-2134","godfreym2@chop.edu",{"name":92,"role":37,"phone":10,"phoneExt":10,"email":10},"Kristy Arbogast, PhD",{"facility":94,"status":50,"city":95,"state":96,"zip":97,"country":54,"countryCode":55,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Hasbro Children's Hospital and Brown University","Providence","Rhode Island","02903",{"type":57,"coordinates":99},[100,101],-71.41283,41.82399,{"lat":101,"lon":100},[104,108,112],{"name":105,"role":40,"phone":106,"phoneExt":10,"email":107},"Stephanie Ruest, MD, MPH","401-606-3532","stephanie_ruest@brown.edu",{"name":109,"role":40,"phone":110,"phoneExt":10,"email":111},"Mhina Johnbaptiste, MPH","954-591-1222","mjohnbaptiste@lifespan.org",{"name":105,"role":37,"phone":10,"phoneExt":10,"email":10},{"facility":114,"status":50,"city":115,"state":116,"zip":117,"country":54,"countryCode":55,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"University of Texas Southwestern Medical Center","Dallas","Texas","75390",{"type":57,"coordinates":119},[120,121],-96.80667,32.78306,{"lat":121,"lon":120},[124,128,132],{"name":125,"role":40,"phone":126,"phoneExt":10,"email":127},"Mohamed Badawy, MD","214-456-7106","Mohamed.Badawy@UTSouthwestern.edu",{"name":129,"role":40,"phone":130,"phoneExt":10,"email":131},"Mia Hamilton, MSW","501-701-0239","mia.hamilton@utsouthwestern.edu",{"name":133,"role":37,"phone":10,"phoneExt":10,"email":10},"Mohamad Badawy, MD",{"facility":135,"status":50,"city":136,"state":116,"zip":137,"country":54,"countryCode":55,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Baylor College of Medicine, Texas Children's Hospital","Houston","77030",{"type":57,"coordinates":139},[140,141],-95.36327,29.76328,{"lat":141,"lon":140},[144,148,152],{"name":145,"role":40,"phone":146,"phoneExt":10,"email":147},"Andrea Cruz, MD, MPH","832-824-5582","acruz@bcm.edu",{"name":149,"role":40,"phone":150,"phoneExt":10,"email":151},"Victor Gonzalez, MD","832-824-5977","vmgonzal@bcm.edu",{"name":145,"role":37,"phone":10,"phoneExt":10,"email":10},{"facility":154,"status":50,"city":155,"state":156,"zip":157,"country":54,"countryCode":55,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"The Medical College of Wisconsin, Inc.","Milwaukee","Wisconsin","53226",{"type":57,"coordinates":159},[160,161],-87.90647,43.0389,{"lat":161,"lon":160},[164,168,172],{"name":165,"role":40,"phone":166,"phoneExt":10,"email":167},"Danny G Thomas, MD, MPH","414-266-2625","dthomas@mcw.edu",{"name":169,"role":40,"phone":170,"phoneExt":10,"email":171},"Najia Ali","414-266-2767","naali@mcw.edu",{"name":165,"role":37,"phone":10,"phoneExt":10,"email":10},{"type":174,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[176],{"name":177,"class":178},"Pediatric Emergency Care Applied Research Network","NETWORK","100544564","screening-emotions-in-adolescents-at-the-hospital-for-mtbi-100544564",false,"NCT06370520","Screening Emotions in Adolescents at the Hospital for mTBI","Screening Emotions in Adolescents Receiving Care at the Hospital for mTBI (SEARCH-mTBI)","SEARCH-mTBI","Inclusion Criteria:\n\nChildren 11 to less than 18 years old who meet the Centers for Disease Control and Prevention (CDC) definition of mTBI\\*. In brief, this is defined as a Glasgow Coma Scale (GCS) score of 13 to 15 with:\n\n\\- Head injury (e.g., direct blow or sudden deceleration\u002Facceleration) plus any neurological sign and\u002For symptom such as headache, nausea, history of loss of consciousness, confusion, dizziness, amnesia (not limited to these symptoms\u002Fsigns)\n\nAND\u002FOR\n\n\\- Traumatic intracranial abnormalities on CT or MRI (such as intracranial hemorrhage, skull fracture, or diffuse axonal injury)\n\n\\*mTBI is defined as an acute brain injury resulting in neurological symptoms such as confusion or disorientation, headache, nausea, loss of consciousness, amnesia, seizure, focal signs or symptoms, and\u002For have traumatic intracranial abnormalities on CT or MRI imaging. mTBI patients have GCS scores of 13 to 15. Per CDC precedent, we will use the term mTBI which encompasses other commonly used terms such as \"concussion\" or \"minor head injury\". This will include patients who may have neuroimaging findings of traumatic abnormalities (e.g., intracranial hemorrhage, diffuse axonal injury, skull fractures) which are risk factors for mental health problems; however, neuroimaging is not required for enrollment into the study.\n\nExclusion Criteria:\n\n* Presentation to the ED \\>72 hours post-injury\n* TBI requiring emergent neurosurgical intervention at the time of enrollment\n* Other injuries requiring emergent surgery at the time of enrollment\n* Parent or child unable to accurately complete the study questionnaires due to preexisting functional limitations (e.g., severe developmental delay)\n* Previous known enrollment into the study\n* Patient or parent does not speak English or Spanish","ALL","11 Years","17 Years",{"count":191,"type":192},2592,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to develop and validate a clinical tool to predict which adolescents aged 11 to less than 18 years of age with mild traumatic brain injury (mTBI) are at an increased risk for developing significant new or worsening mental health conditions.\n\nThe main aims the study wish to answer are:\n\n* Does the adolescent have new or worsening depression or anxiety defined as a change from their previous medical history using self-reported questionnaires at either one or three months post-injury?\n* Does the adolescent have unmet mental health care needs, defined as not receiving any mental or behavior health care in patients with new or worsening anxiety or depression as defined by the self reported questionnaires?\n\nParticipants will be enrolled after being diagnosed in the emergency department (ED) with an mTBI. During the ED visit, the child's parent\u002Fcaregiver and the adolescent will complete several questionnaires related to mental health which include tools to measure anxiety and depression. Participants will be asked to complete these questionnaires again at 1 month and 3 months post enrollment.",[196,197,198,199,200,201,202,203,204,205],"Brain Injury Traumatic Mild","Brain Injuries","Brain Injuries, Acute","Head Injury With Intracranial Hemorrhage","Head Injury Trauma","Brain Injury Traumatic Focal With Loss of Consciousness","Skull Fractures","Diffuse Axonal Injury","Intracranial Hemorrhages","Head Injury",[207,208,209,197,210,211],"Child","Concussion","Wounds and Injuries","Head Injuries Trauma","Loss of Consciousness","2025-09-22",{"date":214,"type":215},"2025-09-26","ACTUAL",{"date":217,"type":215},"2024-05-22",{"date":219,"type":192},"2028-12",{"name":5,"class":6},6]