Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-09 @ 2:23 PM
Study NCT ID:
NCT02656758
Status:
UNKNOWN
Last Update Posted:
2016-10-11
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Executive Function Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-09', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-01-14', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in attention deficit hyperactivity disorder-rating scale', 'timeFrame': 'baseline, after the training (12 weeks)'}], 'secondaryOutcomes': [{'measure': 'Change in behavior rating scale of executive function', 'timeFrame': 'baseline, after the training (12 weeks)'}, {'measure': 'Cambridge Neuropsychological Test Automatic Battery', 'timeFrame': 'baseline, after the training (12 weeks)'}, {'measure': 'Behavior Rating Inventory of Executive Function', 'timeFrame': 'baseline, after the training (12week)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'The investigators intent to recruit 80 attention deficit hyperactivity disorder families. The attention deficit hyperactivity disorder families had received executive function training one year before.They will be randomized to intervention group and control group using a block randomization design. The intervention group will participate in intensive executive function training immediately,while the control group will receive executive training after 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of child attention deficit hyperactivity disorder\n* full-scale intelligence quotient (FSIQ) ≥70\n* stable on medication for attention deficit hyperactivity disorder children at least 3 months\n* participation in the early implementation of functional training one year before\n\nExclusion Criteria:\n\n* individuals with major neurological disorders\n* a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders'}, 'identificationModule': {'nctId': 'NCT02656758', 'briefTitle': 'Intensive Executive Function Training', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'A Randomized Controlled Study on the Effect of Intensive Functional Training on Children With Attention Deficit Hyperactivity Disorder', 'orgStudyIdInfo': {'id': 'Z151100004015103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Executive function training', 'description': 'the experimental group will receive 12 sessions of intensive Executive function training weekly immediately', 'interventionNames': ['Behavioral: intensive Executive function training']}, {'type': 'OTHER', 'label': 'the waitlist group', 'description': 'the waitlist group will wait 12 weeks before receiving intensive executive function training for comparison.', 'interventionNames': ['Behavioral: intensive Executive function training']}], 'interventions': [{'name': 'intensive Executive function training', 'type': 'BEHAVIORAL', 'description': 'Children diagnosis of attention deficit hyperactivity disorder are randomized to the experimental condition(Executive Function training) or waiting group experimental:participants will receive 12 sessions of intensive executive function training weekly no intervention :waiting participants will not be treated with intensive executive function training and keep waiting for 12 weeks for comparison', 'armGroupLabels': ['Executive function training', 'the waitlist group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Sixth Hospital/Institute of Mental Health', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Ying Qian', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Sixth Hospital/Institute of Mental Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZIli Fan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'postgraduate', 'investigatorFullName': 'ZIli Fan', 'investigatorAffiliation': 'Peking University'}}}}