Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-20 @ 10:58 PM
Study NCT ID:
NCT01691066
Status:
COMPLETED
Last Update Posted:
2020-06-26
First Post:
2012-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-24', 'studyFirstSubmitDate': '2012-09-19', 'studyFirstSubmitQcDate': '2012-09-19', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of a novel behavioral treatment', 'timeFrame': '24 months', 'description': 'Assessment of Outcome:\n\nAttendance. Attendance to parent education sessions will be recorded by the therapist.\n\nParent utilization. To assess the acceptability of the PRT approach, parents will be asked to keep a weekly log of procedure use, including overall estimated duration and choice of activities.'}, {'measure': 'Acceptability of a novel behavioral treatment', 'timeFrame': '24 months', 'description': 'Assessment of Outcome:\n\nParent satisfaction. At post-treatment, parents will be asked to complete a Likert-scale and short response questionnaire rating their satisfaction with various aspects of the program'}]}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study aims to investigate the utility of Pivotal Response Treatment (PRT), a behaviorally derived intervention, to improve the quality and frequency of communication and social engagement of toddlers with siblings who have an autism spectrum disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social interaction between 12 and 15 months of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Months', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* toddlers, age 12 - 15 months, who have an older sibling with ASD\n* delays of at least 1.5 standard deviations in communication (receptive/expressive language) based on developmental testing\n* scores that exceed the ASD cutoff on standardized measures of social-communicative behavior\n\nExclusion Criteria:\n\n* physical or neurological disorder (e.g., seizures, cerebral palsy)'}, 'identificationModule': {'nctId': 'NCT01691066', 'briefTitle': 'Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': '1110009256'}, 'secondaryIdInfos': [{'id': 'R03MH092617', 'link': 'https://reporter.nih.gov/quickSearch/R03MH092617', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infant Toddler Years PRT', 'description': 'Infant Toddler PRT in an evidence-based, manualized treatment for children with autism spectrum disorder that involves specific motivational behavioral procedures adapted to be developmentally appropriate for 12-15 month old infants who present with developmental delays.', 'interventionNames': ['Behavioral: Infant Toddler Years PRT']}, {'type': 'NO_INTERVENTION', 'label': 'Community Treatment', 'description': 'Community Treatment includes the treatments offered by early intervention services (e.g., speech-language therapy, special education instruction).'}], 'interventions': [{'name': 'Infant Toddler Years PRT', 'type': 'BEHAVIORAL', 'otherNames': ['Pivotal Response Treatment'], 'armGroupLabels': ['Infant Toddler Years PRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Child Study Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Katarzyna Chawarska, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}