Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT00004458
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Longitudinal and Biological Study of Childhood Disintegrative Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 220}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1997-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-10', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-10-18', 'studyFirstSubmitQcDate': '1999-10-18', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-10-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['autism', 'childhood disintegrative disorder', 'neurologic and psychiatric disorders', 'rare disease'], 'conditions': ['Pervasive Child Development Disorders', 'Autism']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Volkmar FR, Klin A, Marans WD, et al.: Childhood disintegrative disorder. In: Cohen DJ, Volkmar FR.: Handbook of autism and pervasive developmental disorders. 2nd ed., New York, NY: John Wiley, 1997, pp 47-59.'}]}, 'descriptionModule': {'briefSummary': 'OBJECTIVES:\n\nI. Compare the developmental course (language acquisition, diagnostic stability, predictors of outcome, and restricted interests and behaviors) of childhood disintegrative disorder versus autism and non-autistic developmental delays.\n\nII. Collect data on molecular genetics of proband and family members.', 'detailedDescription': 'PROTOCOL OUTLINE:\n\nPatients are evaluated with the following questionnaires at ages 2-3 years and again at ages 5-9: The Autism Diagnostic Interview (ADI); The Autism Diagnostic Observation Schedule (ADOS); Assessment of cognitive functioning; Expressive and receptive language; Adaptive functioning; Measures of burden and functional assessment; The Aberrant Behavior Checklist; The Connors Rating Scale - Parent and Teacher version; and Autism Behavior Checklist\n\nAn MRI and EEG are performed, and blood samples are collected from patients and family members for molecular genetic studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Psychologically diagnosed (DSM-IV) as Childhood Disintegrative Disorder\n* No known genetic or medical syndrome (Down syndrome or cerebral palsy)\n* Must speak English'}, 'identificationModule': {'nctId': 'NCT00004458', 'briefTitle': 'Longitudinal and Biological Study of Childhood Disintegrative Disorder', 'organization': {'class': 'NIH', 'fullName': 'Office of Rare Diseases (ORD)'}, 'orgStudyIdInfo': {'id': '199/13682'}, 'secondaryIdInfos': [{'id': 'YALE-5P01HD0300830'}, {'id': 'YALE-HIC-5895'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Child Study Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Fred Volkmar', 'role': 'STUDY_CHAIR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, 'collaborators': [{'name': 'Yale University', 'class': 'OTHER'}]}}}