Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-27 @ 9:20 PM
Study NCT ID:
NCT01340092
Status:
COMPLETED
Last Update Posted:
2016-04-25
First Post:
2011-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D002658', 'term': 'Developmental Disabilities'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-22', 'studyFirstSubmitDate': '2011-04-20', 'studyFirstSubmitQcDate': '2011-04-20', 'lastUpdatePostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hours of Services', 'timeFrame': '6 months after enrollment', 'description': 'Mean number of autism-specific service hours received per week'}, {'measure': 'Receipt of adequate services', 'timeFrame': '6 months after enrollment', 'description': 'As defined by 25 hours/week'}, {'measure': 'Time to Receipt of Services', 'timeFrame': '6 months after enrollment', 'description': 'Difference between the date of the IEP/IFPS and date the child first received services'}], 'secondaryOutcomes': [{'measure': 'Family Psychological Functioning', 'timeFrame': '6 months after enrollment', 'description': '* Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR).\n* Parenting Stress - Short Form (PSI)\n* Perceived Stress Scale- Self-Report (PSS)\n* Medical Outcomes Study Social Support (MOS-SS)'}, {'measure': 'Family Psychological Functioning', 'timeFrame': 'Baseline', 'description': '* Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR).\n* Parenting Stress - Short Form (PSI)\n* Perceived Stress Scale- Self-Report (PSS)\n* Medical Outcomes Study Social Support (MOS-SS)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Family Navigator', 'Autistic Disorder', 'Early Intervention', 'Developmental Disabilities', 'Child Development Disorders'], 'conditions': ['Autistic Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see whether or not Family Navigators, who 1 ) help families after their child is diagnosed with autism and help them get autism specific services for their child 2) help families identify barriers to obtaining these services and 3) help families problem solve to overcome these barrier, are helpful to parents of a child newly diagnosed with an Autism Spectrum Disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '64 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child with a new confirmed diagnosis of Autism Spectrum Disorder\n* Child is under 8 years of age\n* Parent is the mother, father and/or legal guardian of the child and identifies themselves as the primary caregiver\n* Primary caregiver speaks English, Spanish, Haitian Creole, Somali, Vietnamese, Portuguese or Chinese\n\nExclusion Criteria:\n\n* Parent or legal guardian has psychosis\n* Parent or legal guardian endorses suicidal ideation\n* Parent or legal guardian actively using illicit drugs\n* Parent or legal guardian expected to leave area within 6 months'}, 'identificationModule': {'nctId': 'NCT01340092', 'briefTitle': 'Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Use of a Family Navigator in Families With Children Newly Diagnosed With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': '29964'}, 'secondaryIdInfos': [{'id': 'HRSA R40MC19928-01-00', 'type': 'OTHER_GRANT', 'domain': 'HRSA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Family Navigator', 'description': 'Family navigation', 'interventionNames': ['Other: Family Navigator']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'standard care'}], 'interventions': [{'name': 'Family Navigator', 'type': 'OTHER', 'description': 'Families in the intervention group will receive approximately six sessions with a Family Navigator. The Family Navigator will:\n\n1. Help family identify key issues they need to address to get their child autism-specific services\n2. Help family address barriers to obtaining these services and strategize approaches to overcome them.', 'armGroupLabels': ['Family Navigator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Marilyn Augustyn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BMC Faculty', 'investigatorFullName': 'Marilyn Augustyn', 'investigatorAffiliation': 'Boston Medical Center'}}}}