Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370520
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-04-12
Brief Title:
Screening Emotions in Adolescents at the Hospital for mTBI
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Screening Emotions in Adolescents Receiving Care at the Hospital for mTBI SEARCH-mTBI
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEARCH-mTBI
Brief 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 childs parentcaregiver 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
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 childs parentcaregiver 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
Detailed Description:
This is an observational multicenter study to develop and validate a clinical tool to predict mental health problems in adolescents after mild traumatic brain injuries mTBI
The primary objective of the study is to develop and validate a clinical tool to predict which adolescents with mTBIs are at an increased risk for developing significant new or worsening mental health conditions The investigators believe that at completion of this study they will have developed and validated a clinical prediction tool that will help clinicians define adolescents with mTBIs by risk of follow up mental health complications into low moderate and high-risk categories This will provide clinicians with distinct risk categories on which make decisions about an adolescents care
The investigators will also evaluate racial ethnic and social and economic differences in post-mTBI management across diverse populations of adolescents with mTBIs The investigators believe that specific racial ethnic social and economical characteristics will also be associated with unmet mental health needs in adolescents with mTBIs
The primary objective of the study is to develop and validate a clinical tool to predict which adolescents with mTBIs are at an increased risk for developing significant new or worsening mental health conditions The investigators believe that at completion of this study they will have developed and validated a clinical prediction tool that will help clinicians define adolescents with mTBIs by risk of follow up mental health complications into low moderate and high-risk categories This will provide clinicians with distinct risk categories on which make decisions about an adolescents care
The investigators will also evaluate racial ethnic and social and economic differences in post-mTBI management across diverse populations of adolescents with mTBIs The investigators believe that specific racial ethnic social and economical characteristics will also be associated with unmet mental health needs in adolescents with mTBIs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None