NCT04826068

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

2.2 years

First QC Date

March 29, 2021

Last Update Submit

October 5, 2023

Conditions

Traumatic Brain Injury

Keywords

Emotional ProcessingPediatric Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Facial Identification Task

    measure of facial affect recognition

    8 weeks

Study Arms (2)

Emotional Processing

EXPERIMENTAL

The intervention looks at emotional processing of face interpretation.

Behavioral: Emotional Processing

Control intervention

PLACEBO COMPARATOR

The control group is seeing the same faces and are asked questions regarding them.

Behavioral: Emotional Processing

Interventions

Emotional ProcessingBEHAVIORAL

Processing Emotions of others based on photographs of faces

Control interventionEmotional Processing

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Director

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

April 1, 2021

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

US(2)