Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-04-16 @ 6:56 PM
Study NCT ID:
NCT05517161
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2022-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Roll for Intervention - TBI Group Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067404', 'term': 'Social Communication Disorder'}], 'ancestors': [{'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-18', 'studyFirstSubmitDate': '2022-08-23', 'studyFirstSubmitQcDate': '2022-08-25', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Goal Attainament Scaling - change over time', 'timeFrame': 'Week 2, 3,4,5,6,7, 8 and 9 of the 10week study protocol', 'description': 'Assessing change over time on five point scaled goals - goal rated each week for 8 weeks.'}], 'secondaryOutcomes': [{'measure': 'Repeatable Battery for the Assessment of Neuropsychological Status Update', 'timeFrame': 'During week 1 and week 10 of the 10 week protocol', 'description': 'Randolf (2012) standardized norm referenced assessment measure of cognitive skills (memory and attention etc.)'}, {'measure': 'Functional Assessment of Verbal Reasoning and Executive Strategies', 'timeFrame': 'During week 1 and week 10 of the 10 week protocol', 'description': 'MacDonald (2005) standardized norm referenced assessment measure of problem solving and reasoning'}, {'measure': 'Sydney psychosocial reintegration scale version 2 (SPRS-2)', 'timeFrame': 'During week 1 and week 10 of the 10 week protocol', 'description': 'Tate (2012) standardized likert based questionnaire (12, 1-5 ratings, where higher scores = better performance)'}, {'measure': 'Satisfaction with life scale (SWLS)', 'timeFrame': 'During week 1 and week 10 of the 10 week protocol', 'description': 'Diener et al (1985), likert measurement scale questionnaire, 5 1-7 ratings, higher scores = better performance'}, {'measure': 'Latrobe Communication Questionnaire (LCQ)', 'timeFrame': 'During week 1 and week 10 of the 10 week protocol', 'description': 'Douglas et al (2000), likert measurement scale questionnaire, 30 1-4 ratings, higher scores = better performance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Communication Disorder, Social']}, 'descriptionModule': {'briefSummary': 'Communication group intervention for individuals with Traumatic Brain Injury based on INSIGHT protocol (Keegan et al, 2020) with roll playing game focus', 'detailedDescription': "Individuals with TBI recruited to participate in a study about applying INSIGHT protocol to a virtual roll playing game environment. The game 'monsters of the week' will be used to administer the cognitive-communication ingredients outlined by INSIGHT (Keegan et al 2020) and progress towards social communication goals will be documented throughout the course of participating in the roll playing campaign (7-8 weeks - meeting 2 hours each week). The individuals without neurological disorders will follow the same protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Group 1: individuals who have received a brain injury at least 1 year prior to enrollment.\n\nGroup 2: age, education and gender matched individuals who have no history of neurological difficulties', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* moderate to severe TBI more than 1 year ago\n\nExclusion Criteria:\n\n* other neurological diagnoses prior to TBI'}, 'identificationModule': {'nctId': 'NCT05517161', 'briefTitle': 'Roll for Intervention - TBI Group Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Moravian University'}, 'officialTitle': 'Roll for Intervention - a Critical Look at the Practicability of Table-top Roll Playing Games as Communication Intervention for Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '22-015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with TBI', 'interventionNames': ['Behavioral: INSIGHT']}], 'interventions': [{'name': 'INSIGHT', 'type': 'BEHAVIORAL', 'description': 'See Keegan et al., 2020', 'armGroupLabels': ['Individuals with TBI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18018', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Moravian University', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}], 'overallOfficials': [{'name': 'Louise C Keegan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moravian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moravian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor & Program Director of Speech-Language Pathology', 'investigatorFullName': 'Louise Keegan', 'investigatorAffiliation': 'Moravian University'}}}}