Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-01-03 @ 11:08 PM
Study NCT ID:
NCT03812068
Status:
UNKNOWN
Last Update Posted:
2019-01-22
First Post:
2019-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parent-mediated Developmental Behavioral Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'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': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-18', 'studyFirstSubmitDate': '2019-01-17', 'studyFirstSubmitQcDate': '2019-01-18', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Autism Diagnostic Observation Schedule', 'timeFrame': '3 months', 'description': 'measurement of autism status and severity level'}, {'measure': 'Child Behavior Checklist Ages 1.5-5', 'timeFrame': '3 months', 'description': "measurement of child's behavioral syndrome and problems"}, {'measure': 'Pediatric Evaluation of Disability Inventory', 'timeFrame': '3 months', 'description': "measurement of child's daily living function"}, {'measure': 'Mullen Scale of Early Learning', 'timeFrame': '3 months', 'description': "measurement of child's cognitive and motor development"}, {'measure': 'Movement Assessment Battery for Children', 'timeFrame': '3 months', 'description': "measurement of child's motor coordination"}, {'measure': '3D Gait Assessment Foot-worn Inertial Sensor', 'timeFrame': '3 months', 'description': 'measurement of gait performance'}, {'measure': 'Peabody Developmental Motor Scales, Second Edition', 'timeFrame': '3 months', 'description': 'measurement of multiple fine and gross motor functions'}], 'secondaryOutcomes': [{'measure': 'Parenting Stress Index', 'timeFrame': '3 months', 'description': 'measurement of parenting stress for parents'}, {'measure': 'Parenting Sense of Competence Scale', 'timeFrame': '3 months', 'description': "measurement of the parent's self-efficacy and satisfaction as being parents"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ASD', 'Early intervention', 'Development'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'This study explores the effectiveness of two intervention programs: "Long-distance developmental behavioral intervention" and "developmental behavioral interventions" for children with autism spectrum disorder or multiple developmental delays.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child's age between 30-84 months old.\n* Children have a diagnosis of autism spectrum disorder or multiple developmental delays.\n* Children without physical disabilities or major health problems, such as congenital limb defects.\n* One of the fathers or mothers involved in the study shall be the primary caregiver of the child.\n* The father or mother participating in the study has at least 9 education years and can read and understand Chinese.\n* The father or mother participating in the study is willing to allow the child to undergo a comprehensive development assessment and is willing to video during the training process.\n\nExclusion Criteria:\n\n* Absence of chromosome abnormalities, congenital anomalies, and major neurological or sensory impairments or disorders (e.g., cerebral palsy, microcephalus, macrocephalus, severe brain damage, uncorrected vision, or hearing loss)."}, 'identificationModule': {'nctId': 'NCT03812068', 'acronym': 'PDBI', 'briefTitle': 'Parent-mediated Developmental Behavioral Intervention', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Effectiveness of a Parent-mediated Developmental Behavioral Intervention for Children With Autism Spectrum Disorder and Developmental Delay: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '201809001RINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long-distance developmental behavioral intervention', 'description': 'Long-distance learning program combined parent-mediated developmental behavioral intervention', 'interventionNames': ['Behavioral: Long-distance developmental behavioral intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Developmental behavioral intervention', 'description': 'only parent-mediated developmental behavioral intervention', 'interventionNames': ['Behavioral: Developmental behavioral intervention']}], 'interventions': [{'name': 'Long-distance developmental behavioral intervention', 'type': 'BEHAVIORAL', 'description': 'Long-distance learning program combined parent-mediated developmental behavioral intervention', 'armGroupLabels': ['Long-distance developmental behavioral intervention']}, {'name': 'Developmental behavioral intervention', 'type': 'BEHAVIORAL', 'description': 'Parent-mediated developmental behavioral intervention', 'armGroupLabels': ['Developmental behavioral intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yen-Tzu Wu, PhD', 'role': 'CONTACT'}], 'facility': 'School and Graduate Institute of Physical Therapy, National Taiwan University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yen-Tzu Wu, PhD', 'role': 'CONTACT', 'email': 'yenwu@ntu.edu.tw', 'phone': '886-2-33668136'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}