Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-02 @ 8:58 AM
Study NCT ID:
NCT04375059
Status:
UNKNOWN
Last Update Posted:
2020-05-05
First Post:
2020-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Attention Training on Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D007859', 'term': 'Learning Disabilities'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-04', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes of symptoms of attention deficit hyperactivity disorder', 'timeFrame': 'score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome', 'description': 'score assessed by Swanson, Nolan and Pelham questionnaire'}], 'secondaryOutcomes': [{'measure': 'changes of sensory integration', 'timeFrame': 'score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome', 'description': 'score assessed by Sensory Profile'}, {'measure': 'changes of visual motor integration', 'timeFrame': 'score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome', 'description': 'score assessed by Beery-Buktenica Visual Motor Integration Test'}, {'measure': 'changes of intelligence', 'timeFrame': 'score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome', 'description': 'score assessed by Wechsler Intelligence Scale for Children'}, {'measure': 'changes of functional performance', 'timeFrame': 'score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome', 'description': 'score assessed by Pediatric Outcome Data Collection Instrument'}, {'measure': 'changes of health-related quality of life', 'timeFrame': 'score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome', 'description': 'score assessed by Pediatric Quality of Life Inventory'}, {'measure': 'changes of family impact', 'timeFrame': 'score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome', 'description': 'Child Health Questionnaire, parent form 28'}, {'measure': 'changes of walking speed', 'timeFrame': 'time change from baseline to 3 months of treatment, and 3 months after treatment', 'description': 'walking speed'}, {'measure': 'changes of chair climbing speed', 'timeFrame': 'time change from baseline to 3 months of treatment, and 3 months after treatment', 'description': 'stairs climbing speed'}, {'measure': 'changes of balance', 'timeFrame': 'time change from baseline to 3 months of treatment, and 3 months after treatment', 'description': 'one leg standing time'}, {'measure': 'changes of coordination', 'timeFrame': 'score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome', 'description': 'Berg Balance Scale'}, {'measure': 'changes of balance and coordination', 'timeFrame': 'time change from baseline to 3 months of treatment, and 3 months after treatment', 'description': 'timed up and go test'}, {'measure': 'changes of physical performance', 'timeFrame': 'time change from baseline to 3 months of treatment, and 3 months after treatment', 'description': '5 time sit to stand test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['attention training', 'children', 'therapeutic effects', 'developmental delay'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'Using a double-blind, randomized controlled design to investigate the therapeutic effects of interactive attention training for children with Attention Deficit Hyperactivity Disorder who are receiving conventional rehabilitation programs due to developmental delay.', 'detailedDescription': "A total of 30 children with Attention Deficit Hyperactivity Disorder conducting conventional rehabilitation programs well be enrolled.\n\nThe children are randomized into two groups, including study group with conventional rehabilitation programs and interactive attention training: 2 times per week, 15 min per session, with a total of 24 sessions in 3 months; and control group with conventional rehabilitation programs without interactive attention training.\n\nTherapeutic effects, including working memory, attention, functional performance, physical function, health-related quality of life will be evaluated at baseline, and 3 months and 6 months after the intervention.\n\nThe evaluator and children will be blinded to the group's allocation during the whole course of the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children with a diagnosis of Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient 70 or greater\n\nExclusion Criteria:\n\n* age less than 4 or greater than 8 of children diagnosed with Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient less than 70'}, 'identificationModule': {'nctId': 'NCT04375059', 'briefTitle': 'Effects of Attention Training on Children', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'Therapeutic Effects of Interactive Attention Training on Children With Attention Deficit Hyperactivity Disorder', 'orgStudyIdInfo': {'id': '2019SKHADR038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study group', 'description': '3 months of interactive attention training programs, 2 times per week, 15 min per session, a total of 24 sessions, with conventional rehabilitation programs', 'interventionNames': ['Other: using interactive attention training system']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '3 months of conventional rehabilitation programs without interactive attention training programs'}], 'interventions': [{'name': 'using interactive attention training system', 'type': 'OTHER', 'description': 'using the interactive attention training system to children with Attention Deficit Hyperactivity Disorder', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111-01', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Shin Kong Wu Ho-Su Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Ru-Lan Hsieh, MD', 'role': 'CONTACT', 'email': 'M001052@ms.skh.org.tw', 'phone': '886228332211', 'phoneExt': '2531'}, {'name': 'Ru-Lan Ru-Lan, MD', 'role': 'CONTACT', 'email': 'M001052@ms.skh.org.tw', 'phone': '886228332211', 'phoneExt': '2531'}], 'overallOfficials': [{'name': 'Ru-Lan Ru-Lan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shin Kong Wu Ho-Su Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Ru-Lan Hsieh', 'investigatorAffiliation': 'Taipei Medical University'}}}}