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NCT04826068 Clinical Trial

Emotional Processing Intervention for Children With TBI

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04826068
Other study ID # E-11220-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date May 31, 2023

Study information
Verified date October 2023
Source Kessler Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigating an emotional processing program, that is modified for use with children, is effective for children with a traumatic brain injury (TBI).

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 17 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Emotional Processing
Processing Emotions of others based on photographs of faces

Locations
Country Name City State
United States Kessler Foundation East Hanover New Jersey
United States Kessler Foundation West Orange New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Facial Identification Task measure of facial affect recognition 8 weeks
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