Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT00956605
Status:
COMPLETED
Last Update Posted:
2009-08-11
First Post:
2009-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial of Computer-based Attention-training Systems in Children With Attention Deficit Hyperactivity Disorder (ADHD)
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', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-10', 'studyFirstSubmitDate': '2009-08-07', 'studyFirstSubmitQcDate': '2009-08-10', 'lastUpdatePostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in ADHD symptoms as reported by caregivers and teachers were measured at enrollment pre-intervention, and then again immediately post-intervention', 'timeFrame': 'Assessments were administered at enrollment in May-June 2006, and then immediately post-intervention after the 3 month intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EEG-biofeedback', 'neurofeedback', 'computer attention training systems', 'ADHD', 'ADD', 'child', 'children'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'This study examines the efficacy of two computer-based training systems to teach children with ADHD to attend more effectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* child in 6th, 7th or 8th grade\n* a diagnosis of ADHD (any subtype) per report of the child's physician\n* academic achievement at grade level\n* ability to read in English sufficiently to complete assessments and intervention protocols\n\nExclusion Criteria:\n\n* coexisting diagnosis of conduct disorder, pervasive developmental disorder, or other serious mental illness (e.g., bipolar disorder, psychosis)"}, 'identificationModule': {'nctId': 'NCT00956605', 'acronym': 'CATS', 'briefTitle': 'A Trial of Computer-based Attention-training Systems in Children With Attention Deficit Hyperactivity Disorder (ADHD)', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'A Randomized Trial of Computer-based Attention-training Systems With and Without Neurofeedback in Children With ADHD', 'orgStudyIdInfo': {'id': '7703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EEG biofeedback intervention', 'interventionNames': ['Behavioral: Computer attention training systems for children with ADHD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non EEG biofeedback computerized attention training', 'interventionNames': ['Behavioral: Computer attention training systems for children with ADHD']}, {'type': 'NO_INTERVENTION', 'label': 'waitlist control'}], 'interventions': [{'name': 'Computer attention training systems for children with ADHD', 'type': 'BEHAVIORAL', 'description': 'Computer attention training systems for children with ADHD, one with and one without EEG-biofeedback, were delivered via approximately 20 sessions to the participants', 'armGroupLabels': ['EEG biofeedback intervention', 'Non EEG biofeedback computerized attention training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center / Tufts University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Naomi Steiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts Medical Center / Tufts University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Robert Bloomberg', 'oldOrganization': 'Tufts Medical Center'}}}}