Screening Emotions in Adolescents at the Hospital for mTBI

Recruiting

• Conditions: Brain Injury Traumatic Mild; Skull Fractures; Head Injury; Head Injury With Intracranial Hemorrhage; Diffuse Axonal Injury; Head Injury Trauma; Brain Injuries; Brain Injuries, Acute; Brain Injury Traumatic Focal With Loss of Consciousness; Intracranial Hemorrhages
• Interventions: Behavioral: Validated Questionnaires; Behavioral: Questionnaires; Other: Clinician / Medical Record Variables

• Registration Number: NCT06370520
• Lead Sponsor: University of California, Davis

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.

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.

Study Timeline

• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Study Start: 2024-05-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-12
• Primary Completion: 2028-09
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2592

Inclusion Criteria

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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Derivation Cohort	Questionnaires	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.
Validation Cohort	Clinician / Medical Record Variables	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.
Derivation Cohort	Clinician / Medical Record Variables	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.
Derivation Cohort	Validated Questionnaires	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.
Validation Cohort	Validated Questionnaires	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.
Validation Cohort	Questionnaires	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.

Primary Outcome Measures

Name	Time	Method
Unmet mental health care needs in patients with new or worsening depression or anxiety	The Mental Health Utilization Questionnaire is completed at approximately 30 days and approximately 90 days after the emergency department (ED) baseline visit.	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.
New or worsening depression or anxiety	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.	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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.
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.	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).
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.	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.

Trial Locations

Locations (6)

University of California, Davis Medical Center; 🇺🇸 Sacramento, California, United States

Hasbro Children's Hospital and Brown University; 🇺🇸 Providence, Rhode Island, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Baylor College of Medicine, Texas Children's Hospital; 🇺🇸 Houston, Texas, United States

The Medical College of Wisconsin, Inc.; 🇺🇸 Milwaukee, Wisconsin, United States