Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT03573128
Status:
COMPLETED
Last Update Posted:
2018-11-16
First Post:
2018-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-14', 'studyFirstSubmitDate': '2018-06-06', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in student function as measured by the Developmental Disability-Clinical Global Assessment Scale', 'timeFrame': 'baseline to end of school year (approx. 9 months)', 'description': 'The Developmental Disability-Clinical Global Assessment Scale ranges from 1-100 with 100 indicating superior functioning. It assesses student function in a classroom setting.'}], 'secondaryOutcomes': [{'measure': "Mean change in social communication and interaction as rated by child's teacher using the 30 item Social Skills Subscale of the Social Skills Improvement System", 'timeFrame': 'baseline to end of school year (approx. 9 months)', 'description': 'The Social Skills Improvement System, Social Skills Subscale is a 30 item measure of social communication and interaction using a 4 point Likert scale to rate the frequency of behaviors and a 3 point Likert scale to the the importance of each item.'}, {'measure': "Mean change in restricted and repetitive behavior as measured by the Children's Yale-Brown Obsessive-Compulsive Scales - PDD", 'timeFrame': 'baseline to end of school year (approx. 9 months)', 'description': "The Children's Yale-Brown Obsessive-Compulsive Scales - PDD is a modified version of the Children's Yale-Brown Obsessive-Compulsive Scales which is adapted for use with children with ASD. It is a semi structured clinician rated scale designed to rate the current severity of repetitive behavior. Each item is scored on a 5 point scale from 0 to 4 with 4 being most symptomatic."}, {'measure': 'Change in teacher-nominated target behaviors', 'timeFrame': 'baseline to end of school year (approx. 9 months)', 'description': 'Teacher Nominated Target Behaviors'}, {'measure': 'Change in on-task behavior during instruction', 'timeFrame': 'baseline to end of school year (approx. 9 months)', 'description': 'Academic Engaged Time'}, {'measure': 'School-related adaptive functioning', 'timeFrame': 'baseline to end of school year (approx. 9 months)', 'description': 'Adaptive Behavior Assessment System, Self-Direction Scale'}, {'measure': 'Social skills and behavior regulation', 'timeFrame': 'baseline to end of school year (approx. 9 months)', 'description': 'Social Skills Improvement System'}, {'measure': 'Class placement', 'timeFrame': 'baseline to end of school year (approx. 9 months)', 'description': 'IEP review'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'Study personnel will use evidence based behavioral skills training procedures to coach educators to implement modules designed to increase the quality of educational services and access to inclusive settings in elementary school for students with Autism Spectrum Disorder.', 'detailedDescription': 'This project brings together the expertise of investigators at three centers to develop and conduct a pilot test of a new comprehensive intervention to increase the quality of educational services and access to inclusive settings for students with autism spectrum disorder (ASD) in elementary school (kindergarten through 5th grade). The intervention model, Students with Autism Accessing General Education (SAAGE), integrates evidence-based strategies to teach skills to students with ASD in schools, best practices derived from this literature by the project investigators, a recent guidebook written by the principal investigator, and research on collaboration with community providers such as school teams to implement interventions efficaciously and sustainably. SAAGE begins with strategies to help a school form a cohesive team to oversee implementation of the model in the school. For each student, SAAGE uses a modular approach for identifying goals for a student, selecting appropriate teaching strategies, and systematically monitoring progress and trouble-shooting. The modules center on core and associated features of ASD. Study personnel will use well established behavioral skills training procedures to coach educators to implement the modules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nChildren subjects:\n\n* Are enrolled in school grades kindergarten through 5th\n* Have an IEP educational classification of Autism, confirmed by the Autism Diagnostic Observation Schedule, Second Edition, and DSM-5 checklist\n* No planned changes in school placement or core team members during the school year of participation\n\nAdult subjects (teachers, para educators):\n\n* Instructional personnel who currently support a participating child with ASD at school (e.g., teacher, instructional assistant, speech pathologist, occupational therapist)\n* Letter from instructional personnel's district or school indicating agreement to take part in the research project\n\nExclusion Criteria:\n\nChildren subjects • Diagnosis of (1) genetic disorders such as Fragile X, Down syndrome, or tuberous sclerosis; 2) profound vision or hearing loss; or (3) motor disabilities such as cerebral palsy (these multiple disabilities would prevent standard implementation of the intervention protocol).\n\nAdult subjects\n\n• Instructional personnel whose written consent was not obtained"}, 'identificationModule': {'nctId': 'NCT03573128', 'acronym': 'SAAGE', 'briefTitle': 'Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model', 'orgStudyIdInfo': {'id': 'R324A150032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Students with Autism Accessing General Education (SAAGE). Teaching staff work with a study team coach to identify areas of concern for individual students, create goals and implement a modular behavioral intervention using an active teaching/feedback loop model.', 'interventionNames': ['Behavioral: Students with Autism Accessing General Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Services As Usual', 'description': 'Teaching staff access in-service training sessions hosted by study team and are provided with print materials from which the modules for the active intervention were created.', 'interventionNames': ['Other: Enhanced Services As Usual']}], 'interventions': [{'name': 'Students with Autism Accessing General Education', 'type': 'BEHAVIORAL', 'description': 'With study team coach support, teacher implemented modules addressing student behavioral/academic goals.', 'armGroupLabels': ['Intervention']}, {'name': 'Enhanced Services As Usual', 'type': 'OTHER', 'description': 'Teaching staff access in-service presentations and print materials with no active study team coaching.', 'armGroupLabels': ['Enhanced Services As Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Tristram H Smith, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'May Institute', 'class': 'OTHER'}, {'name': 'University of South Florida', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Suzannah Iadarola', 'investigatorAffiliation': 'University of Rochester'}}}}