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Clinical Trials/NCT04826068
NCT04826068
Completed
N/A

The Application and Modification of an Emotional Processing Intervention for Children With Traumatic Brain Injury

Kessler Foundation1 site in 1 country10 target enrollmentApril 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Kessler Foundation
Enrollment
10
Locations
1
Primary Endpoint
Facial Identification Task
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
May 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Principal Investigator
Principal Investigator

Jean Lengenfelder

Assistant Director

Kessler Foundation

Eligibility Criteria

Inclusion Criteria

  • Ages of 9 and
  • 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.

Outcomes

Primary Outcomes

Facial Identification Task

Time Frame: 8 weeks

measure of facial affect recognition

Study Sites (1)

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