Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-05 @ 12:07 AM
Study NCT ID:
NCT05418933
Status:
UNKNOWN
Last Update Posted:
2022-06-14
First Post:
2022-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Workshops for Children With Global Developmental Delays
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007859', 'term': 'Learning Disabilities'}], 'ancestors': [{'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'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intervention group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 101}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-12', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-06-12', 'lastUpdatePostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pediatric Outcome Data Collection Instrument', 'timeFrame': 'scores change of Pediatric Outcome Data Collection Instrument from baseline to 6 weeks after treatment', 'description': 'measure the functional performance of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome'}], 'secondaryOutcomes': [{'measure': 'Mandarin-Chinese Communicative Developmental Inventory', 'timeFrame': 'percent change of Mandarin-Chinese Communicative Developmental Inventory from baseline to 6 weeks after treatment', 'description': 'assess communication function of children, \\<10% indicates delayed development, 10% or more than 10% indicates normal development'}, {'measure': 'Peabody Developmental Motor Scale', 'timeFrame': 'scores change of Peabody Developmental Motor Scale from baseline to 6 weeks after treatment', 'description': 'assess fine motor function of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome'}, {'measure': 'Emotional Competency Rating Scale', 'timeFrame': 'scores change of Emotional Competency Rating Scale from baseline to 6 weeks after treatment', 'description': 'assess the emotional function of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome'}, {'measure': 'Pediatric Evaluation of Disability Inventory', 'timeFrame': 'scores change of Pediatric Evaluation of Disability Inventory from baseline to 6 weeks after treatment', 'description': 'assess the functional skill attainment of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome'}, {'measure': 'Pediatric Daily Occupation Scale', 'timeFrame': 'scores change Pediatric Daily Occupation Scale from baseline to 6 weeks after treatment', 'description': 'assess the occupational performance in the daily life of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome'}, {'measure': 'Pediatric Quality of Life Inventory-Geriatric Core Scale', 'timeFrame': 'scores change ofPediatric Quality of Life Inventory-Geriatric Core Scale from baseline to 6 weeks after treatment', 'description': 'assess the quality of life of children, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome'}, {'measure': 'Pediatric Quality of Life Inventory-Family Impact Module', 'timeFrame': 'scores change of Pediatric Quality of Life Inventory-Family Impact Module from baseline to 6 weeks after treatment', 'description': 'assess the impact of pediatric conditions on family functioning and parental quality of life, the minimum and maximum values range from 1 to 100, higher scores mean a better outcome'}, {'measure': 'Parental satisfaction questionnaire', 'timeFrame': 'scores of Parental satisfaction questionnaire after treatment', 'description': "assess the parents' satisfaction with the workshops, with scores ranging from 1-to 100, higher scores mean a higher satisfaction"}, {'measure': 'Caregiver Strain Index', 'timeFrame': 'scores change of Caregiver Strain Index from baseline to 6 weeks after treatment', 'description': 'assess family strain, the minimum and maximum values range from 1 to 100, higher scores mean a worse outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['family workshops'], 'conditions': ['Global Developmental Delay']}, 'referencesModule': {'references': [{'pmid': '36792650', 'type': 'DERIVED', 'citation': 'Hsieh WH, Huang PC, Tsai PC, Lee W, Hu Y, Lee WC, Hsieh RL. Short-term multidisciplinary family-centered workshop for preschool children with global developmental delays. Pediatr Res. 2023 Aug;94(2):707-714. doi: 10.1038/s41390-023-02507-3. Epub 2023 Feb 15.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the therapeutic effects of family workshops on children with global developmental delays and their parents by the analysis of the previously conducted workshops.', 'detailedDescription': 'To evaluate the effects of family workshops for children aged 18-36 months old with language developmental delays conducted from Jan 2014 Jan to Dec 2018, by the data analysis.\n\nThe participants were children with global developmental delay (language delay with at least one delay in motor, cognitive function, or emotional and social functioning) and their parents in the workshops.\n\nThe family workshops were conducted with 5 courses, with 6-7 families in one course, a 2-hour session per week, for 6 weeks.\n\nEffects:\n\n1. Investigate the therapeutic effects of workshops for children with global developmental delays\n2. Investigate the therapeutic effects of workshops for the parents of children with global developmental delays'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 18-36 months old with global developmental delays (language developmental delay, with motor, cognition, or social and emotional developmental delays) Parents and children attended the one 2 hour-session of workshop per week for 6 weeks\n\nExclusion Criteria:\n\n* Less than 18 months old or older than 36 months old'}, 'identificationModule': {'nctId': 'NCT05418933', 'briefTitle': 'Workshops for Children With Global Developmental Delays', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'Effects of Family Workshops on Children With Global Developmental Delays and Their Parents', 'orgStudyIdInfo': {'id': 'SKH-111-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Family workshops with 5 courses, with 6-7 families in one course, 2 hours per session, one time per week, for a total of 6 weeks.', 'interventionNames': ['Other: Family workshop']}], 'interventions': [{'name': 'Family workshop', 'type': 'OTHER', 'description': 'Family workshops for 5 courses, with 6-7 families in one course. The workshops were 2 hours per session, one time per week, for a total of 6 weeks.', 'armGroupLabels': ['Intervention 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': '886-2-28332211', 'phoneExt': '2531'}, {'name': 'Hsieh, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Hsieh, 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': 'MD, Professor', 'investigatorFullName': 'Ru-Lan Hsieh', 'investigatorAffiliation': 'Taipei Medical University'}}}}