Brain Injury Traumatic MildSEARCH-mTBINCT06370520
Screening Emotions in Adolescents at the Hospital for mTBI
An observational study of Brain Injury Traumatic Mild and Brain Injuries, run by University of California, Davis at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Brain Injury Traumatic Mild, Brain Injuries, Brain Injuries, Acute
- What is being tested?
- Validated Questionnaires, Questionnaires and Clinician / Medical Record Variables
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,592 participants
- Where
- 6 sitesUnited States
- Study dates
- 22 May 2024to Dec 2028
- Phase
- Observational
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 11 to 17 years
- All sexes
- Child
Study population: Participants are injured children aged 11 to 17 years old who present with a Mild traumatic brain injury (mTBI), including concussion, as defined by the Centers for Disease Control and Prevention as an acute brain injury resulting in neurological symptoms such as confusion or disorientation, loss of consciousness, amnesia, seizure, or other signs or symptoms combined with a Glasgow Coma Scale (GCS) score of 13 to 15 to one of six emergency departments (EDs) throughout the United States.
Who may be able to join
- Children 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:
- Head injury (e.g., direct blow or sudden deceleration/acceleration) plus any neurological sign and/or symptom such as headache, nausea, history of loss of consciousness, confusion, dizziness, amnesia (not limited to these symptoms/signs)
- AND/OR
- Traumatic intracranial abnormalities on CT or MRI (such as intracranial hemorrhage, skull fracture, or diffuse axonal injury)
- 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/or 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.
Who cannot join
- Presentation to the ED >72 hours post-injury
- TBI requiring emergent neurosurgical intervention at the time of enrollment
- Other injuries requiring emergent surgery at the time of enrollment
- Parent or child unable to accurately complete the study questionnaires due to preexisting functional limitations (e.g., severe developmental delay)
- Previous known enrollment into the study
- Patient or parent does not speak English or Spanish
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Mohamed Badawy, MD, 214-456-7106, Mohamed.Badawy@UTSouthwestern.edu
Mia Hamilton, MSW, 501-701-0239, mia.hamilton@utsouthwestern.edu
- Recruiting
Baylor College of Medicine, Texas Children's Hospital
Houston, Texas, 77030
Andrea Cruz, MD, MPH, 832-824-5582, acruz@bcm.edu
Victor Gonzalez, MD, 832-824-5977, vmgonzal@bcm.edu
- Recruiting
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226
Danny G Thomas, MD, MPH, 414-266-2625, dthomas@mcw.edu
Najia Ali, 414-266-2767, naali@mcw.edu
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Daniel Corwin, MD, 215-327-2306, corwind@chop.edu
Melissa Godfrey, MPH, 302-598-2134, godfreym2@chop.edu
- Recruiting
Hasbro Children's Hospital and Brown University
Providence, Rhode Island, 02903
Stephanie Ruest, MD, MPH, 401-606-3532, stephanie_ruest@brown.edu
Mhina Johnbaptiste, MPH, 954-591-1222, mjohnbaptiste@lifespan.org
- Recruiting
University of California, Davis Medical Center
Sacramento, California, 95817
Maria Marois, PhD, MPH, 916-734-0373, mtmarois@health.ucdavis.edu
Kyle Pimenta, BAS, 916-734-8847, kpimenta@health.ucdavis.edu
About this study
Official title: Screening Emotions in Adolescents Receiving Care at the Hospital for mTBI (SEARCH-mTBI)
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:
Read more
- 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.
Read the detailed description
This is an observational, multicenter study to develop and validate a clinical tool to predict mental health problems in adolescents (after mild traumatic brain injuries (mTBI).
The primary objective of the study is to develop and validate a clinical tool to predict which adolescents with mTBIs are at an increased risk for developing significant new or worsening mental health conditions. The investigators believe that at completion of this study they will have developed and validated a clinical prediction tool that will help clinicians define adolescents with mTBIs by risk of follow up mental health complications into low, moderate, and high-risk categories. This will provide clinicians with distinct risk categories on which make decisions about an adolescents care.
The investigators will also evaluate racial, ethnic, and social and economic differences in post-mTBI management across diverse populations of adolescents with mTBIs. The investigators believe that specific racial, ethnic, social, and economical characteristics will also be associated with unmet mental health needs in adolescents with mTBIs.
- Conditions
- 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
- Being tested
- Validated Questionnaires, Questionnaires, Clinician / Medical Record Variables
- Keywords
- Child, Concussion, Wounds and Injuries, Brain Injuries, Head Injuries Trauma, Loss of Consciousness
- Medical subject headings
- Brain Concussion, Brain Injuries, Intracranial Hemorrhage, Traumatic, Skull Fractures, Diffuse Axonal Injury, Intracranial Hemorrhages, Craniocerebral Trauma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validated QuestionnairesBehavioural
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)
QuestionnairesBehavioural
Early Physical Activity/Return to School Questionnaire, Mental Health Utilization Questionnaire
Clinician / Medical Record VariablesOther
Medical History, Emergency Department Clinical Variables
| Study group | Role | What they receive |
|---|---|---|
| Derivation Cohort | 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. Receives: Behavioral: Validated Questionnaires; Behavioral: Questionnaires; Other: Clinician / Medical Record Variables | |
| 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. Receives: Behavioral: Validated Questionnaires; Behavioral: Questionnaires; Other: Clinician / Medical Record Variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
New or worsening depression or anxiety
New or worsening depression or anxiety are binary variables (yes/no) defined as a change from the retrospective baseline score collected on the self-reported Generalized Anxiety Disorder-7 questionnaire (GAD-7) equal to or greater than 4 points, and/or a change from the baseline score collected on the self-reported Patient Health Questionnaire-8 (PHQ-8) equal to or greater than 5 points.
The Generalized Anxiety Disorder-7 (GAD-7) contains seven items, each of which is scored 0 to 3, providing a 0 to 21 severity score where higher values indicate worsening severity.
The Patient Health Questionnaire-8 (PHQ-8) contains eight items, each of which is scored 0 to 3, providing a 0 to 24 severity score where higher values indicate worsening severity.
Measured: The Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-8 (PHQ-8) are measured at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.
Unmet mental health care needs in patients with new or worsening depression or anxiety
Unmet mental health care needs are defined as a binary variable (yes/no) if participants received any mental or behavioral health care as collected on the self-reported Mental Health Utilization Questionnaire completed the parent of the participant. Mental or behavioral health care includes, but is not limited to behavioral, cognitive-behavioral, interpersonal therapy, psychotherapy, and counseling. Medications alone will not fulfill the criteria of mental or behavior health care.
Measured: The Mental Health Utilization Questionnaire is completed at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.
Secondary outcomes (4)
Decline in quality of life
A decline in the patient's quality of life is a binary variable (yes/no) defined as a decrease from the retrospective baseline score collected on the self-reported Pediatric Quality of Life Inventory questionnaire (PedsQL) equal to or greater than a 4.5 points.
The Pediatric Quality of Life Inventory questionnaire (PedsQL) contains 23 items, each of which is scored 0 to 4, and is scored on a range from 0 to 100, with lower scores indicated a lower quality of life.
Measured: The Pediatric Quality of Life Inventory Questionnaire (PedsQL) is measured at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.
Persistent mTBI symptoms
Persistent mTBI is a binary variable (yes/no) defined as an increase from the retrospective baseline score collected on the Rivermead Post Concussion Questionnaire of greater than or equal to 2 points on any three symptoms.
The Rivermead Post Concussion Questionnaire consists of the sixteen items divided into two groups. The first three items make up the first sub-group scored from 0 to 12, and the next 13 items make up the second sub-group scored from 0 to 52. The entire questionnaire is scored from 0 to 64 where higher values indicate worsening severity.
Measured: The Rivermead Post Concussion Questionnaire is measured at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.
New deficits in emotional/behavioral functioning or hyperactivity/inattention
The Strengths and Difficulties Questionnaire (SDQ) is comprised of 4 sub scales of 5 items each for a total of 20 questions. Each sub scale has a minimum score of 0 and a maximum score of 10 where higher values indicate worsening severity.
New deficits in emotional/behavioral functioning or participant hyperactivity/inattention are binary variables (yes/no) defined as a new score of 5 points or greater on the emotional/behavioral functioning sub scales or 6 points or greater on the hyperactivity/inattention sub scale as collected from the self-reported Strengths and Difficulties Questionnaire (SDQ).
Measured: The Strengths and Difficulties Questionnaire (SDQ) is measured at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.
Parent Perception of Unmet Mental Health Needs
Parent Perception of Unmet Mental Health Needs is a binary variable (yes/no) defined as the parent perception of unmet mental health needs in participants with new or worsening anxiety or depression identified at the 1 month and 3 month follow up visits. This will be assessed using the Mental Health Utilization Questionnaire completed by parents.
Unmet mental health care needs are defined as a binary variable (yes/no) if participants received any mental or behavioral health care as collected on the self-reported Mental Health Utilization Questionnaire completed the parent of the participant.
Measured: The Mental Health Utilization Questionnaire is completed at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start22 May 2024
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Injury Traumatic MildStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,592 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Emergency Care Applied Research Network
- Responsible party
- Sponsor
- Investigators
- Daniel K Nishijima, MD, MAS, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370520
- Sponsor's protocol ID
- 2122025
- Acronym
- SEARCH-mTBI
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nishijima DK, Kuppermann N, Suskauer SJ, Arbogast KB, Badawy M, Casper TC, Cruz AT, Corwin DJ, Johnson TJ, Rosenthal ED, Ruest SM, Tancredi DJ, Thomas DG, Zonfrillo MR, Slomine BS; SEARCH-mTBI Study Group. Screening Emotions in Adolescents Receiving Care at the Hospital for mild Traumatic Brain Injury (SEARCH-mTBI): protocol for a multicenter observational study. BMC Pediatr. 2026 Apr 7;26(1):450. doi: 10.1186/s12887-026-06788-5.
PubMed 41943020