RECRUITING

Screening Emotions in Adolescents at the Hospital for mTBI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Screening Emotions in Adolescents Receiving Care at the Hospital for mTBI (SEARCH-mTBI)

Quick Facts

Study Start:2024-05-22
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06370520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Presentation to the ED \>72 hours post-injury
  2. * TBI requiring emergent neurosurgical intervention at the time of enrollment
  3. * Other injuries requiring emergent surgery at the time of enrollment
  4. * Parent or child unable to accurately complete the study questionnaires due to preexisting functional limitations (e.g., severe developmental delay)
  5. * Previous known enrollment into the study
  6. * Patient or parent does not speak English or Spanish

Contacts and Locations

Study Contact

Daniel K Nishijima, MD, MAS
CONTACT
916-734-3884
dnishijima@ucdavis.edu
Nathan Kuppermann, MD, MPH
CONTACT
916-734-1535
nkuppermann@ucdavis.edu

Principal Investigator

Daniel K Nishijima, MD, MAS
PRINCIPAL_INVESTIGATOR
University of California, Davis

Study Locations (Sites)

University of California, Davis Medical Center
Sacramento, California, 95817
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Hasbro Children's Hospital and Brown University
Providence, Rhode Island, 02903
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Baylor College of Medicine, Texas Children's Hospital
Houston, Texas, 77030
United States
The Medical College of Wisconsin, Inc.
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: University of California, Davis

  • Daniel K Nishijima, MD, MAS, PRINCIPAL_INVESTIGATOR, University of California, Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-22
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-05-22
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Child
  • Concussion
  • Wounds and Injuries
  • Brain Injuries
  • Head Injuries Trauma
  • Loss of Consciousness

Additional Relevant MeSH Terms

  • Brain Injury Traumatic Mild
  • Brain Injuries
  • Brain Injuries, Acute
  • Head Injury With Intracranial Hemorrhage
  • Head Injury Trauma
  • Brain Injury Traumatic Focal With Loss of Consciousness
  • Skull Fractures
  • Diffuse Axonal Injury
  • Intracranial Hemorrhages
  • Head Injury