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NCT06370520 · ClinicalTrials.gov registry record
Screening Emotions in Adolescents at the Hospital for mTBI
A clinical trial of Brain Injuries and Head Injury, sponsored by University of California, Davis.
- Recruiting
- Registry status
- 2,592
- Enrollment target
- 6
- Study locations
NCT06370520: Recruiting study of Brain Injuries and Head Injury, sponsored by University of California, Davis.
NCT06370520 is a study of Brain Injuries and Head Injury that is actively recruiting participants, run by University of California, Davis. The registered enrollment target is 2,592 participants, above the 213-participant average among 22 other Brain Injuries trials with a reported enrollment target (1117% higher). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06370520, a study of Brain Injuries and Head Injury, is actively recruiting participants, sponsored by University of California, Davis.
- RECRUITING
- Registry status
- 2,592 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL Questionnaires
- BEHAVIORAL Validated Questionnaires
- OTHER Clinician / Medical Record Variables
Study Locations (6)
Texas
- University of Texas Southwestern Medical Center - Dallas
- Baylor College of Medicine, Texas Children's Hospital - Houston
California
- University of California, Davis Medical Center - Sacramento
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Rhode Island
- Hasbro Children's Hospital and Brown University - Providence
Wisconsin
- The Medical College of Wisconsin, Inc. - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,592 participants |
| Start Date | 2024-05-22 |
| Est. Completion | 2028-12 |
What NCT06370520 shows while recruiting
NCT06370520 is an observational study that tracks outcomes without assigning an intervention. Its 2,592 participants enrollment target places it among the larger protocols in the corpus, above the 213-participant average among 22 other Brain Injuries trials with a reported enrollment target (1117% higher).
The record links to 10 conditions, with Brain Injuries appearing as the primary indexed condition, and to 3 interventions - of which Questionnaires is the first listed.
NCT06370520 lists 6 locations in 5 states (Texas, California, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT06370520 about?
NCT06370520 is a clinical study titled "Screening Emotions in Adolescents at the Hospital for 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 ...
What is the current status of trial NCT06370520?
This trial is currently recruiting. The enrollment target is 2,592 participants. The study started on 2024-05-22. Estimated completion is 2028-12.
What conditions does trial NCT06370520 study?
This clinical trial studies the following conditions: Brain Injuries, Head Injury, Intracranial Hemorrhages, Brain Injury Traumatic Mild, Head Injury Trauma.
What interventions are being tested in trial NCT06370520?
The interventions under investigation include: Questionnaires (BEHAVIORAL), Validated Questionnaires (BEHAVIORAL), Clinician / Medical Record Variables (OTHER).
Who is sponsoring clinical trial NCT06370520?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06370520 being conducted?
This trial has 6 study locations across California, Pennsylvania, Rhode Island, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06370520's enrollment target sits among peer trials
2,592 1st of 22 higher than 22 of 22 other Brain Injuries trials
participants (enrollment target), bucketed by value
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