Ignite Creation Date:
2024-05-06 @ 7:09 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02475044
Status:
UNKNOWN
Last Update Posted:
2016-10-11
First Post:
2015-06-08
Brief Title:
Mild Traumatic Brain Injuries in Children Predicting Behavioral and Emotional Deficits
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Mild Traumatic Brain Injuries in Children Predicting Behavioral and Emotional Deficits
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The purpose of this study is to investigate the role of psychosocial factors in creating Persistent Post-concussive symptoms PPCS The researchers investigate three hypotheses a Do pre-injury psycho-environmental deficits predict a higher level of PPCS b Do socio-demographic and personal pre-injury deficits relate to 1 a more negative attribution for the child injury by their parents and 2 embracing of a more permissive and authoritarian parenting and do these factors mediate the symptoms preservation c Does Cognitive-Behavioral Therapy CBT benefit to reducing PPCS emotional and behavioral symptoms
Detailed Description:
200 children and adolescents with post concussion will be followed for 9 months since the time of the head injury Post concussive symptoms along emotional distress and neurocognitive deficits will be examined at 2 weeks 4 months and 9 months since the injury using self report questionnaires psychological evaluation and neuropsychological tests Participants who demonstrates PPCS 4 months after the injury will be assigned either to the Cognitive Behavioral Treatmet group CBT or to the Treatment as Ususal groupTAU The change in symptoms severity PCS emotional distress and neurocognitive deficits will be compared between the two study groups in order to assess treatment efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None