Screening Emotions in Adolescents at the Hospital for mTBI

NCT06370520 | Recruiting

• 1 other identifier: 2122025
• Study Type: observational
• Target: 2,592
• Locations: 1 country
• Sites: 6

Brief 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. 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.

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; Skull Fractures; Diffuse Axonal Injury; Intracranial Hemorrhages; Head Injury

Keywords

Child; Concussion; Wounds and Injuries; Brain Injuries; Head Injuries Trauma; Loss of Consciousness

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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 measured at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.

• Parent Perception of Unmet Mental Health Needs

  The Mental Health Utilization Questionnaire is completed at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.

Study Arms (2)

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.

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.

Behavioral: Validated Questionnaires; Behavioral: Questionnaires; Other: Clinician / Medical Record Variables

Interventions

Validated Questionnaires BEHAVIORAL

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)

Derivation Cohort; Validation Cohort

Questionnaires BEHAVIORAL

Early Physical Activity/Return to School Questionnaire, Mental Health Utilization Questionnaire

Derivation Cohort; Validation Cohort

Clinician / Medical Record Variables OTHER

Medical History, Emergency Department Clinical Variables

Derivation Cohort; Validation Cohort

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Pediatric Emergency Care Applied Research Network: collaborator

Study Sites (6)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Hasbro Children's Hospital and Brown University

Providence, Rhode Island, 02903, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Baylor College of Medicine, Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

The Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Brain Injuries; Intracranial Hemorrhage, Traumatic; Skull Fractures; Diffuse Axonal Injury; Intracranial Hemorrhages; Craniocerebral Trauma; Wounds and Injuries; Unconsciousness

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Fractures, Bone; Brain Injuries, Diffuse; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Daniel K Nishijima, MD, MAS

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel K Nishijima, MD, MAS

CONTACT

916-734-3884; dnishijima@health.ucdavis.edu

Nathan Kuppermann, MD, MPH

CONTACT

916-734-1535; nkuppermann@health.ucdavis.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: May 22, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)