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Emotional Processing Intervention for Children With TBI

Kessler Foundation logo

Kessler Foundation

Status

Completed

Conditions

Traumatic Brain Injury

Treatments

Behavioral: Emotional Processing

Study type

Interventional

Funder types

Other

Identifiers

NCT04826068
E-11220-20

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

9 to 17 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

10 participants in 2 patient groups, including a placebo group

Emotional Processing
Experimental group
Description:
The intervention looks at emotional processing of face interpretation.
Treatment:
Behavioral: Emotional Processing
Control intervention
Placebo Comparator group
Description:
The control group is seeing the same faces and are asked questions regarding them.
Treatment:
Behavioral: Emotional Processing

Trial contacts and locations

2

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Central trial contact

Nancy Moore

Data sourced from clinicaltrials.gov

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