Back to resultsEmotional Processing Intervention for Children With TBI
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Processing
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Emotional Processing, Pediatric Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
Ages of 9 and 17. Speak and read English fluently.
Healthy Volunteer or
Have sustained a TBI at least 1 year ago, that has affected his or her ability to process emotions.
Exclusion Criteria:
Previous stroke, MS, or neurological injury or disease in the past (like brain tumor or epilepsy) other than TBI.
History of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis).
Uncontrolled seizures or other unstable medical complications.
Sites / Locations
- Kessler Foundation
- Kessler Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Emotional Processing
Control intervention
Arm Description
The intervention looks at emotional processing of face interpretation.
The control group is seeing the same faces and are asked questions regarding them.
Outcomes
Primary Outcome Measures
Facial Identification Task
measure of facial affect recognition
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04826068
Brief Title
Emotional Processing Intervention for Children With TBI
Official Title
The Application and Modification of an Emotional Processing Intervention for Children With Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigating an emotional processing program, that is modified for use with children, is effective for children with a traumatic brain injury (TBI).
Detailed Description
The first stage of this project will evaluate the appropriateness of an emotional processing intervention modified for a pediatric population. The researchers will modify the intervention prior to the evaluation by the 15 typically developing children.
The second stage of the project will evaluate the effectiveness of an emotional processing intervention to improve performance on tests of emotional processing in individuals with TBI. Emotional processing includes both facial affect recognition and social perception measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Emotional Processing, Pediatric Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Emotional Processing
Arm Type
Experimental
Arm Description
The intervention looks at emotional processing of face interpretation.
Arm Title
Control intervention
Arm Type
Placebo Comparator
Arm Description
The control group is seeing the same faces and are asked questions regarding them.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Processing
Intervention Description
Processing Emotions of others based on photographs of faces
Primary Outcome Measure Information:
Title
Facial Identification Task
Description
measure of facial affect recognition
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages of 9 and 17. Speak and read English fluently.
Healthy Volunteer or
Have sustained a TBI at least 1 year ago, that has affected his or her ability to process emotions.
Exclusion Criteria:
Previous stroke, MS, or neurological injury or disease in the past (like brain tumor or epilepsy) other than TBI.
History of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis).
Uncontrolled seizures or other unstable medical complications.
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Emotional Processing Intervention for Children With TBI
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