Emotional Processing Intervention for Children With TBI

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

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

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Emotional Processing

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Kessler Foundation
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emotional Processing; The intervention looks at emotional processing of face interpretation.	Behavioral: Emotional Processing; Processing Emotions of others based on photographs of faces
Placebo Comparator: Control intervention; The control group is seeing the same faces and are asked questions regarding them.	Behavioral: Emotional Processing; Processing Emotions of others based on photographs of faces

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial Identification Task	measure of facial affect recognition	8 weeks

Collaborators and Investigators

• Sponsor: Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Emotional Processing; Pediatric Traumatic Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: E-11220-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No