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Completed

NCT Number: NCT03573128

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Students with Autism Accessing General Education

Behavioral

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

Enhanced Services As Usual

Other

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

Primary outcomes

  1. Mean change in student function as measured by the Developmental Disability-Clinical Global Assessment Scale

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

    The Developmental Disability-Clinical Global Assessment Scale ranges from 1-100 with 100 indicating superior functioning. It assesses student function in a classroom setting.

Secondary outcomes

  1. 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

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

    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.

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

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

    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.

  3. Change in teacher-nominated target behaviors

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

    Teacher Nominated Target Behaviors

  4. Change in on-task behavior during instruction

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

    Academic Engaged Time

  5. School-related adaptive functioning

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

    Adaptive Behavior Assessment System, Self-Direction Scale

  6. Social skills and behavior regulation

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

    Social Skills Improvement System

  7. Class placement

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

    IEP review

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • May Institute
  • University of South Florida

Registry information

Acronym: SAAGE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2018
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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