Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-04-18 @ 1:30 AM
Study NCT ID:
NCT02115334
Status:
COMPLETED
Last Update Posted:
2015-02-27
First Post:
2013-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-25', 'studyFirstSubmitDate': '2013-09-27', 'studyFirstSubmitQcDate': '2014-04-15', 'lastUpdatePostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in clinical assessment after 8 weeks intervention of PHPA at 6 months', 'timeFrame': 'baseline, 8 weeks, 3 months, 6 months', 'description': 'The clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT).'}], 'secondaryOutcomes': [{'measure': 'change from baseline in Chinese Child Developmental Inventory (CCDI) after 8 weeks intervention of PHPA at 6 months', 'timeFrame': 'baseline, 8 weeks, 3 months, 6 months', 'description': 'Measurement of CCDI.'}, {'measure': "change from baseline in Assessment of preschool children's participation(APCP) after 8 weeks intervention of PHPA at 6 months", 'timeFrame': 'baseline, 8 weeks, 3 months, 6 months', 'description': 'Measurement of APCP.'}, {'measure': 'change from baseline in TN0-AZL Preschool quality of life (TAPQOL) after 8 weeks intervention of PHPA at 6 months', 'timeFrame': 'baseline, 8 weeks, 3 months, 6 months', 'description': 'Measurement of TAPQOL.'}, {'measure': 'change from baseline in parent stress index (PSI) after 8 weeks intervention of PHPA at 6 months', 'timeFrame': 'baseline, 8 weeks, 3 months, 6 months', 'description': 'Measurement of PSI.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Developmental delay', 'Early Intervention', 'Home programs', 'Preschool activities'], 'conditions': ['Developmental Delay']}, 'descriptionModule': {'briefSummary': 'Early intervention refers to the provision of early detection, early diagnosis, and early intervention for infants and young children with special needs. The implementation of home programs is very important for children with developmental delay (DD). Therefore, the purposes of this study are to: (1) design the preschool home program activities(PHPA), (2) investigate the immediate efficacy of PHPA for children with DD, (3) investigate the long-term efficacy of PHPA for children with DD.The second year is to investigate the immediate efficacy of PHPA for children with DD.', 'detailedDescription': "A total of 36 children with DD, aged 2-6 years, were randomly assigned to the professional-based group (professional therapists delivering the PHPA, total n=13), parents-based group (parents executing the PHPA, n=12) and control group (health education only, n=11). Outcome measures included clinical assessments and subjective questionnaires. The clinical assessments were Comprehensive Developmental Inventory for Infants and Toddlers (CDIIT). The subjective questionnaires were Chinese Child Developmental Inventory (CCDI), Assessment of preschool children's participation (APCP), TN0-AZL Preschool quality of life (TAPQOL) and parent stress index (PSI). Tests were administrated before and after the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 0 to 6-years-old children\n* clinical diagnosis of DD and other related disorders\n\nExclusion Criteria:\n\n* unstable physiological conditions\n* progression or regression symptoms'}, 'identificationModule': {'nctId': 'NCT02115334', 'briefTitle': 'Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Development and Effectiveness of Home-based Programs for Preschool Children With Developmental Delay:a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '100-0996A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'professional-based group', 'description': 'professional therapists delivering the PHPA', 'interventionNames': ['Behavioral: professional therapists delivering the PHPA']}, {'type': 'EXPERIMENTAL', 'label': 'parents-based group', 'description': 'parents executing the PHPA', 'interventionNames': ['Behavioral: parents executing the PHPA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'health education only', 'interventionNames': ['Behavioral: health education']}], 'interventions': [{'name': 'professional therapists delivering the PHPA', 'type': 'BEHAVIORAL', 'otherNames': ['PHPA(delivered by professional therapists)'], 'description': 'PHPA are delivered by professional therapists, which including gross motor, fine motor, cognition verbal, social interactions, activity of daily living(ADL).', 'armGroupLabels': ['professional-based group']}, {'name': 'parents executing the PHPA', 'type': 'BEHAVIORAL', 'otherNames': ['PHPA (executed by parents)'], 'description': 'PHPA are executed by parents, which including gross motor, fine motor, cognition verbal, social interactions, ADL.', 'armGroupLabels': ['parents-based group']}, {'name': 'health education', 'type': 'BEHAVIORAL', 'description': 'health education of the children with DD.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'state': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Chia-Ling Chen, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}