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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 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.

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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.

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

FieldValue
Enrollment Target 2,592 participants
Start Date 2024-05-22
Est. Completion 2028-12

Sponsor

University of California, Davis

657 total trials

What the Registry Record Tells You About NCT06370520

The ClinicalTrials.gov registry entry for NCT06370520 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 2,592 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 213-participant average among 22 other Brain Injuries trials with a reported enrollment target (1117% higher). The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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