Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-29 @ 4:39 PM
Study NCT ID:
NCT00947700
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2009-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Connections, Early Detection and Intervention in Infants at Risk for Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-18', 'studyFirstSubmitDate': '2009-07-24', 'studyFirstSubmitQcDate': '2009-07-27', 'lastUpdatePostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Autism Symptoms', 'timeFrame': '12 months', 'description': 'AOSI'}, {'measure': 'Mullen Receptive Language Scale', 'timeFrame': '12 months', 'description': 'Mullen Receptive Language Scale SS'}, {'measure': 'Communication and Symbolic Behavior Scale', 'timeFrame': '12 months', 'description': 'CSBS Total Composite Score'}], 'secondaryOutcomes': [{'measure': 'Parent Child Interaction', 'timeFrame': '12 months', 'description': 'NCAST Caregiver Total'}, {'measure': 'Parent quality of life', 'timeFrame': '12 months', 'description': 'Questionnaire on Resources and Stress Total Score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infants', 'Risk markers', 'ERP', 'Parent child interaction', 'Promoting First Relations', 'Social Communication'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'Early connections has two broad goals:\n\n* to identify risk indices for autism spectrum disorder (ASD) in 6 to 24 month old infants who have an older sibling with ASD or infants who have an older neurotypical sibling.\n* to assess whether it is possible to alter risk processes through early intervention with high-risk infants, thereby reducing social-communication delays or the severity of autism symptoms.', 'detailedDescription': 'Researchers at the University of Washington want to learn more about the benefits of early monitoring and intervention for younger siblings of children with autism spectrum disorders (ASD). The information gained in this study may improve methods of early detection and intervention for infants who may be at risk for developing autism and lead to better outcome for these young children and their families.\n\nParticipants include families with a child who has been diagnosed with an autism spectrum disorder or typical development and a younger sibling 12 months old or younger. The study protocol includes: (1) comprehensive infant evaluations at the University of Washington Autism Center at 6-months, 12-months, 18-months and 24-months of age. (2) Developmental screening for the older sibling. (3) Questionnaires and phone interviews for parents. (4) Random assignment to an assessment and monitoring intervention group or a University of Washington intervention group. All families will receive advice regarding appropriate intervention services. Families who are assigned to the UW intervention will take part in a parent delivered intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '5 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older sibling with ASD (biologically related to participant)\n* Participant 12 months of age or younger\n* Within 1 hour of University of Washington\n* Interested in participating in Intervention\n\nExclusion Criteria:\n\n* Out of study area\n* Serious parent substance abuse or psychiatric history\n* Diagnosis of known genetic syndromes or neurological conditions (infant participant or older sibling)\n* Serious motor impairment (infant participant)\n* Significant prematurity (infant participant)'}, 'identificationModule': {'nctId': 'NCT00947700', 'briefTitle': 'Early Connections, Early Detection and Intervention in Infants at Risk for Autism', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'UW ACE Project II, Early Detection and Intervention in Infants at Risk for Autism', 'orgStudyIdInfo': {'id': '32400'}, 'secondaryIdInfos': [{'id': 'P50HD055782', 'link': 'https://reporter.nih.gov/quickSearch/P50HD055782', 'type': 'NIH'}, {'id': 'P30ES007033', 'link': 'https://reporter.nih.gov/quickSearch/P30ES007033', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Assessment & Monitoring', 'description': 'No Intervention. Parent-Child participants in assessment and monitoring visits but does not receive any study provided treatment.'}, {'type': 'EXPERIMENTAL', 'label': 'Assessment, Monitoring + Intervention', 'description': 'Parent-Child participants in assessment and monitoring visits but also the Promoting First Relationships PFR intervention (http://pfrprogram. Org). PFR is a 10 weekly 60-85 minute in-home visits by a masters level mental health provider trained in the PFR curriculum. The PFR curriculum focuses on increasing parenting sensitivity using attachment theory-informed, strength-based consultation strategies. The curriculum is fully manualized and fidelity was assessed according to the manual.', 'interventionNames': ['Behavioral: Assessment, Monitoring & Intervention']}], 'interventions': [{'name': 'Assessment, Monitoring & Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Promoting First Relationships'], 'description': 'Assessment and monitoring at 6, 12, 18 and 24 months; Parent delivered intervention provided between 6 and 12 months.', 'armGroupLabels': ['Assessment, Monitoring + Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Center on Human Development and Disabilities, University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Bryan King, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Sara J Webb, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Annette Estes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Participant level data was submitted to NDAR.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}, {'name': 'Autism Speaks', 'class': 'OTHER'}, {'name': 'Washington State Department of Social and Health Services', 'class': 'OTHER'}, {'name': 'Autism Science Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Psychiatry and Behavioral Sciences', 'investigatorFullName': 'Sara Jane Webb', 'investigatorAffiliation': 'University of Washington'}}}}