Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-03-03 @ 2:19 AM
Study NCT ID:
NCT02797418
Status:
TERMINATED
Last Update Posted:
2021-08-13
First Post:
2016-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Cognitus & Moi": a New Cognitive Remediation Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008607', 'term': 'Intellectual Disability'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Recruitment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-06', 'studyFirstSubmitDate': '2016-06-08', 'studyFirstSubmitQcDate': '2016-06-08', 'lastUpdatePostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aberrant Behavior Checklist scale', 'timeFrame': '6 months', 'description': 'Change in sub-score " hyperactivity / non compliance " (scale " Aberrant Behavior Checklist ") (completed by parents or the educational team). This measure is repeated at the end of the intervention to highlight the impact of the " Cognitus and Me " program, and 6 months later to investigate the possible long-lasting effects of the benefits.'}], 'secondaryOutcomes': [{'measure': 'MDI-C scale ( Multiscore Depression Inventory for Children scale)', 'timeFrame': '6 months', 'description': 'The Aberrant Behavior Checklist-Community (ABC-C; Aman \\& Singh, 1994) is a rating scale that measures the severity of a range of problem behaviors commonly observed in individuals with intellectual and developmental disabilities'}, {'measure': 'KIDSCREEN-27 scale', 'timeFrame': '6 months', 'description': 'The KIDSCREEN-27 with five dimensions resulted. All five dimensions are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy \\& Parents (7 items), Peers \\& Social Support (4 items), and School Environment (4 items).'}, {'measure': 'Vineland 2 scale (Vineland Adaptive Behavior Scale)', 'timeFrame': '6 months', 'description': 'A measure of adaptive behavior from birth to adulthood'}, {'measure': 'ABC scale (Irritability and social withdrawal)', 'timeFrame': '6 months', 'description': 'This measure is repeated at the end of the intervention to highlight the impact of the " Cognitus and Me " program, and 6 months later to investigate the possible long-lasting effects of the benefits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Attentional disorders, intellectual deficiency'], 'conditions': ['Mental Retardation']}, 'referencesModule': {'references': [{'pmid': '30029627', 'type': 'DERIVED', 'citation': 'Favre E, Peyroux E, Babinet MN, Poisson A, Demily C. Computer-based cognitive remediation program for the treatment of behavioral problems in children with intellectual disability: the <<COGNITUS & MOI>> study protocol for a randomized controlled trial. BMC Psychiatry. 2018 Jul 20;18(1):235. doi: 10.1186/s12888-018-1810-z.'}]}, 'descriptionModule': {'briefSummary': 'Holders children with intellectual disabilities have great difficulty in adapting to social situations and relationships.Cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. In the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved.Cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. Currently, no program can meet specific and validated the problems are children with intellectual disabilities manner in their daily functioning.', 'detailedDescription': 'Cognitus \\& ME is a remediation program focused on attentional functions and visuospatial, to limit the presence of behavioral disorders among children with intellectual disabilities.The main objective is to validate the effectiveness of Cognitus \\& ME program on behavioral disorders in children with intellectual disabilities (with or without autism spectrum disorder associated).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with intellectual deficiency (5-13 years) (40 \\< total IQ \\< 75) with or without autism spectrum disorders\n* Native French speaker\n* Clinically stable\n* Parental consent\n\nExclusion Criteria:\n\n* visual or auditory disorder\n* history of neurological illness or trauma\n* Absence of language'}, 'identificationModule': {'nctId': 'NCT02797418', 'acronym': 'COGNITUS', 'briefTitle': '"Cognitus & Moi": a New Cognitive Remediation Tool', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital le Vinatier'}, 'officialTitle': '"Cognitus & Moi": a New Cognitive Remediation Tool for Children With Intellectual Deficiency With Behavioral Disorders', 'orgStudyIdInfo': {'id': '2015-A00858-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitus and Me', 'description': 'Cognitus \\& Me is a cognitiv remediation program focused on the functions of attention and visuospatial that is to say that can move in space, to perceive objects of our environment and organize them, to mentally imagine a physically absent operation object very involved in social behavior, in order to limit the presence of behavioral disorders among children with intellectual disabilities.', 'interventionNames': ['Behavioral: Cognitive remediation program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'the control management that involves fine motor skills and research computer information,management control is usually done', 'interventionNames': ['Behavioral: Cognitive remediation program']}], 'interventions': [{'name': 'Cognitive remediation program', 'type': 'BEHAVIORAL', 'description': 'Comparison between a cognitive remediation program (Cognitus and Me") (groupe 1) and a training group of fine motor skills (group 2)', 'armGroupLabels': ['Cognitus and Me', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69678', 'city': 'Bron', 'state': 'LYON', 'country': 'France', 'facility': 'Demily Caroline', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'DEMILY DR CAROLINE, MD PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Le Vinatier Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital le Vinatier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}