Emotional Screening for Concussion
(SEARCH-mTBI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to develop a tool to predict whether adolescents with mild traumatic brain injury (mTBI), also known as concussions, are at risk of developing or worsening mental health issues such as anxiety or depression. Participants will complete mental health questionnaires during their emergency department visit and again at one and three months post-injury to monitor any changes. This study suits adolescents who have recently experienced a head injury and exhibit symptoms like headaches or dizziness. As an unphased trial, it offers participants the chance to contribute to important research that could enhance future mental health care for adolescents with mTBI.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.
What prior data suggests that this method is safe for adolescents with mTBI?
In a previous study, researchers examined the use of questionnaires to predict mental health issues in teenagers with mild traumatic brain injury (mTBI). The study showed that these questionnaires safely gather information, as participants only answer questions about their feelings, posing no physical risks. This process is well-tolerated, with no reports of negative effects.
The questionnaires assist doctors in determining if a teenager is likely to experience new or worsening depression or anxiety after an mTBI. Since this method involves only answering surveys, it is considered safe for participants.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it focuses on improving the way we screen emotional effects in adolescents with mild traumatic brain injuries (mTBI). Unlike traditional methods that might not capture the full range of emotional and psychological impacts after a head injury, this trial uses validated questionnaires to gather comprehensive data from a large group of children. By enrolling both a derivation cohort and a validation cohort, the study aims to refine and confirm the screening process, potentially leading to more accurate and earlier detection of emotional issues caused by mTBI. This could ultimately help tailor interventions more effectively for young patients.
What evidence suggests that these questionnaires are effective for predicting mental health risks in adolescents with mTBI?
Research has shown that certain questionnaires effectively identify mental health issues in people with mild traumatic brain injury (mTBI). For example, tools like the PHQ-9 and GAD-7 accurately detect depression and anxiety in mTBI patients. In this trial, participants in both the Derivation Cohort and the Validation Cohort will complete or be evaluated with validated questionnaires to monitor changes in mental health and assess the risk of developing new or worsening symptoms after a concussion. These tools help identify mental health needs that might otherwise go unnoticed, ensuring that those affected receive the right care and support.36789
Who Is on the Research Team?
Daniel K Nishijima, MD, MAS
Principal Investigator
University of California, Davis
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants and their caregivers complete mental health questionnaires during the ED visit
Follow-up
Participants complete follow-up questionnaires to assess mental health at 1 month and 3 months post-enrollment
What Are the Treatments Tested in This Trial?
Interventions
- Questionnaires
- Validated Questionnaires
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
Pediatric Emergency Care Applied Research Network
Collaborator
Citations
Screening for Traumatic Brain Injury: Findings and Public ...
Screening using the Brain Injury Screening Questionnaire finds that 27% to 54% of those in high-risk populations report a history of TBI with chronic symptoms.
Knowledge and attitudes toward mild traumatic brain injury ...
Results: A total of 573 valid questionnaires were analyzed (289 males, 50.44%;. 284 females, 49.56%). Among respondents, 258 (45.03%) had ...
Diagnostic Accuracy of Mental Health Screening Tools ...
The findings of this diagnostic study suggest that the PHQ-9, GAD-7 and PC-PTSD-5 accurately screen for mental health disorders in patients with mTBI.
Post-Concussion Symptom Scale (PCSS) Questionnaire
Learn how the Post-Concussion Symptom Scale (PCSS) is used to track recovery, its benefits, and its limitations in concussion diagnosis and ...
Comparative predictive validity of a psychological risk ...
The STarT back screening tool holds promise for the TBI population, as research demonstrates psychological constructs associated with chronic pain are similar ...
The prognostic value of a screening tool for psychological ...
We selected the most prominent baseline predictors of outcome from previous prognostic modelling studies that were available in both datasets: age, gender, ...
Screening Emotions in Adolescents at the Hospital for mTBI
This is an observational, multicenter study to develop and validate a clinical tool to predict mental health problems in adolescents (after mild traumatic brain ...
Psychological Transdiagnostic Processes in Mild ...
Fourteen different self-report measures of avoidance were identified, with the Fear Avoidance After Traumatic Brain Injury (FAB-TBI) Questionnaire yielding the ...
Prediction of Mental Health Complications Following Mild ...
The present study aimed to identify risk factors and develop prognostic model(s) for mental health complications following mTBI.
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