Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-01 @ 11:39 AM
Study NCT ID:
NCT04826068
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emotional Processing Intervention for Children With TBI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-05', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Facial Identification Task', 'timeFrame': '8 weeks', 'description': 'measure of facial affect recognition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emotional Processing', 'Pediatric Traumatic Brain Injury'], 'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'Investigating an emotional processing program, that is modified for use with children, is effective for children with a traumatic brain injury (TBI).', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAges of 9 and 17. Speak and read English fluently.\n\nHealthy Volunteer or\n\nHave sustained a TBI at least 1 year ago, that has affected his or her ability to process emotions.\n\nExclusion Criteria:\n\nPrevious stroke, MS, or neurological injury or disease in the past (like brain tumor or epilepsy) other than TBI.\n\nHistory of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis).\n\nUncontrolled seizures or other unstable medical complications.'}, 'identificationModule': {'nctId': 'NCT04826068', 'briefTitle': 'Emotional Processing Intervention for Children With TBI', 'organization': {'class': 'OTHER', 'fullName': 'Kessler Foundation'}, 'officialTitle': 'The Application and Modification of an Emotional Processing Intervention for Children With Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'E-11220-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emotional Processing', 'description': 'The intervention looks at emotional processing of face interpretation.', 'interventionNames': ['Behavioral: Emotional Processing']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control intervention', 'description': 'The control group is seeing the same faces and are asked questions regarding them.', 'interventionNames': ['Behavioral: Emotional Processing']}], 'interventions': [{'name': 'Emotional Processing', 'type': 'BEHAVIORAL', 'description': 'Processing Emotions of others based on photographs of faces', 'armGroupLabels': ['Control intervention', 'Emotional Processing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Kessler Foundation', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}, {'zip': '07052', 'city': 'West Orange', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Kessler Foundation', 'geoPoint': {'lat': 40.79871, 'lon': -74.23904}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kessler Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Director', 'investigatorFullName': 'Jean Lengenfelder', 'investigatorAffiliation': 'Kessler Foundation'}}}}