protocolSection identificationModule nctId: NCT06370520, orgStudyIdInfo id: 123, briefTitle: Screening Emotions in Adolescents at the Hospital for mTBI, acronym: SEARCH-mTBI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-09, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of California, Davis, class: OTHER, collaborators name: Pediatric Emergency Care Applied Research Network, descriptionModule briefSummary: 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.The main aims the study wish to answer are:* 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?* 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?Participants will be enrolled after being diagnosed in the emergency department (ED) with an mTBI. During the ED visit, the child's parent/caregiver 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., conditionsModule conditions: Brain Injury Traumatic Mild, conditions: Brain Injuries, conditions: Brain Injuries, Acute, conditions: Head Injury With Intracranial Hemorrhage, conditions: Head Injury Trauma, conditions: Brain Injury Traumatic Focal With Loss of Consciousness, conditions: Skull Fractures, conditions: Diffuse Axonal Injury, conditions: Intracranial Hemorrhages, conditions: Head Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2592, type: ESTIMATED, armsInterventionsModule interventions name: Validated Questionnaires, interventions name: Questionnaires, interventions name: Clinician / Medical Record Variables, outcomesModule primaryOutcomes measure: New or worsening depression or anxiety, primaryOutcomes measure: Unmet mental health care needs in patients with new or worsening depression or anxiety, secondaryOutcomes measure: Decline in quality of life, secondaryOutcomes measure: Persistent mTBI symptoms, secondaryOutcomes measure: New deficits in emotional/behavioral functioning or hyperactivity/inattention, secondaryOutcomes measure: Parent Perception of Unmet Mental Health Needs, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of California, Davis Medical Center, city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Maria Marois, PhD, MPH, role: CONTACT, phone: 916-734-0373, email: mtmarois@ucdavis.edu, contacts name: Kyle Pimenta, BAS, role: CONTACT, phone: 916-734-8847, email: kpimenta@ucdavis.edu, contacts name: Daniel K Nishijima, MD, MAS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Children's Hospital of Philadelphia, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Daniel Corwin, MD, role: CONTACT, phone: 215-327-2306, email: corwind@chop.edu, contacts name: Melissa Godfrey, MPH, role: CONTACT, phone: 302-598-2134, email: godfreym2@chop.edu, contacts name: Kristy Arbogast, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Hasbro Children's Hospital and Brown University, city: Providence, state: Rhode Island, zip: 02903, country: United States, contacts name: Mark Zonfrillo, MD, role: CONTACT, phone: 401-606-3532, email: mark_zonfrillo@brown.edu, contacts name: Mhina Johnbaptiste, MPH, role: CONTACT, phone: 954-591-1222, email: mjohnbaptiste@lifespan.org, contacts name: Mark Zonfrillo, MD, MSCE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.82399, lon: -71.41283, locations facility: University of Texas Southwestern Medical Center, city: Dallas, state: Texas, zip: 75390, country: United States, contacts name: Mohamed Badawy, MD, role: CONTACT, phone: 214-456-7106, email: Mohamed.Badawy@UTSouthwestern.edu, contacts name: Aja Bayo, MSc, role: CONTACT, phone: 214-457-1793, email: aja.bayo@utsouthwestern.edu, contacts name: Mohamad Badawy, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Baylor College of Medicine, Texas Children's Hospital, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Andrea Cruz, MD, MPH, role: CONTACT, phone: 832-824-5582, email: acruz@bcm.edu, contacts name: Victor Gonzalez, MD, role: CONTACT, phone: 832-824-5977, email: vmgonzal@bcm.edu, contacts name: Andrea Cruz, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: The Medical College of Wisconsin, Inc., city: Milwaukee, state: Wisconsin, zip: 53226, country: United States, contacts name: Danny G Thomas, MD, MPH, role: CONTACT, phone: 414-266-2625, email: dthomas@mcw.edu, contacts name: Najia Ali, role: CONTACT, phone: 414-266-2767, email: naali@mcw.edu, contacts name: Danny G Thomas, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.0389, lon: -87.90647, hasResults: False