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

NCT03573128 | Completed

• 1 other identifier: R324A150032
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  baseline to end of school year (approx. 9 months)

• Mean change in restricted and repetitive behavior as measured by the Children's Yale-Brown Obsessive-Compulsive Scales - PDD

  baseline to end of school year (approx. 9 months)

• Change in teacher-nominated target behaviors

  baseline to end of school year (approx. 9 months)

• Change in on-task behavior during instruction

  baseline to end of school year (approx. 9 months)

• School-related adaptive functioning

  baseline to end of school year (approx. 9 months)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Students with Autism Accessing General Education

Enhanced Services As Usual

ACTIVE COMPARATOR

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.

Other: Enhanced Services As Usual

Interventions

Students with Autism Accessing General Education BEHAVIORAL

With study team coach support, teacher implemented modules addressing student behavioral/academic goals.

Intervention

Enhanced Services As Usual OTHER

Teaching staff access in-service presentations and print materials with no active study team coaching.

Enhanced Services As Usual

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• May Institute: collaborator
• University of South Florida: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Tristram H Smith, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 29, 2018
• Study Start: August 1, 2017
• Primary Completion: August 28, 2018
• Study Completion: August 28, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)