← Back to Search

Derivation Cohort for Diffuse Axonal Injury (SEARCH-mTBI Trial)

N/A
Recruiting
Led By Daniel K Nishijima, MD, MAS
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the mental health utilization questionnaire is completed at approximately 30 days and approximately 90 days after the emergency department (ed) baseline visit.
Awards & highlights

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.

Eligible Conditions
  • Diffuse Axonal Injury
  • Traumatic Brain Injury
  • Intracranial Hemorrhage
  • Brain Bleed
  • Head Injury
  • Concussion
  • Skull Fractures

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the strengths and difficulties questionnaire (sdq) is measured at approximately 30 days and approximately 90 days after the emergency department (ed) baseline visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the strengths and difficulties questionnaire (sdq) is measured at approximately 30 days and approximately 90 days after the emergency department (ed) baseline visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
New or worsening depression or anxiety
Unmet mental health care needs in patients with new or worsening depression or anxiety
Secondary outcome measures
Decline in quality of life
New deficits in emotional/behavioral functioning or hyperactivity/inattention
Parent Perception of Unmet Mental Health Needs
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Validation CohortExperimental Treatment3 Interventions
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.
Group II: Derivation CohortExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3330

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
919 Previous Clinical Trials
4,718,300 Total Patients Enrolled
Pediatric Emergency Care Applied Research NetworkNETWORK
5 Previous Clinical Trials
10,761 Total Patients Enrolled
Daniel K Nishijima, MD, MASPrincipal InvestigatorUniversity of California, Davis
2 Previous Clinical Trials
2,031 Total Patients Enrolled
~1728 spots leftby Sep 2028