Clinical trial NCT03573128: Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model
Official title: Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: May Institute
name: University of South Florida
First posted: 2018-06-29
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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)
Secondary outcomes:
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)
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)
measure: Change in teacher-nominated target behaviors
timeFrame: baseline to end of school year (approx. 9 months)
measure: Change in on-task behavior during instruction
timeFrame: baseline to end of school year (approx. 9 months)
measure: School-related adaptive functioning
timeFrame: baseline to end of school year (approx. 9 months)
measure: Social skills and behavior regulation
timeFrame: baseline to end of school year (approx. 9 months)
measure: Class placement
timeFrame: baseline to end of school year (approx. 9 months)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Tristram H Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: