Autism Spectrum Disorder Clinical Trial
— SAAGEOfficial title:
Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model
Verified date | November 2018 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | August 28, 2018 |
Est. primary completion date | August 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Children subjects: - Are enrolled in school grades kindergarten through 5th - Have an IEP educational classification of Autism, confirmed by the Autism Diagnostic Observation Schedule, Second Edition, and DSM-5 checklist - No planned changes in school placement or core team members during the school year of participation Adult subjects (teachers, para educators): - Instructional personnel who currently support a participating child with ASD at school (e.g., teacher, instructional assistant, speech pathologist, occupational therapist) - Letter from instructional personnel's district or school indicating agreement to take part in the research project Exclusion Criteria: Children 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). Adult subjects • Instructional personnel whose written consent was not obtained |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | May Institute, University of South Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change in student function as measured by the Developmental Disability-Clinical Global Assessment Scale | The Developmental Disability-Clinical Global Assessment Scale ranges from 1-100 with 100 indicating superior functioning. It assesses student function in a classroom setting. | baseline to end of school year (approx. 9 months) | |
Secondary | 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 | 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. | baseline to end of school year (approx. 9 months) | |
Secondary | Mean change in restricted and repetitive behavior as measured by the Children's Yale-Brown Obsessive-Compulsive Scales - PDD | 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. | baseline to end of school year (approx. 9 months) | |
Secondary | Change in teacher-nominated target behaviors | Teacher Nominated Target Behaviors | baseline to end of school year (approx. 9 months) | |
Secondary | Change in on-task behavior during instruction | Academic Engaged Time | baseline to end of school year (approx. 9 months) | |
Secondary | School-related adaptive functioning | Adaptive Behavior Assessment System, Self-Direction Scale | baseline to end of school year (approx. 9 months) | |
Secondary | Social skills and behavior regulation | Social Skills Improvement System | baseline to end of school year (approx. 9 months) | |
Secondary | Class placement | IEP review | baseline to end of school year (approx. 9 months) |
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