Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model

Autism Spectrum Disorder Clinical Trial

— SAAGE  

Official title:

Development and Pilot Testing of the Students With Autism Accessing General Education (SAAGE) Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03573128
• Other study ID #: R324A150032
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: August 28, 2018

Study information

• Verified date: November 2018
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• Students with Autism Accessing General Education
With study team coach support, teacher implemented modules addressing student behavioral/academic goals.

Other:
• Enhanced Services As Usual
Teaching staff access in-service presentations and print materials with no active study team coaching.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	May Institute, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

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)