Rochester, New York 14642

  • Autism Spectrum Disorder

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

R324A150032


NCT ID:

NCT03573128


Secondary ID:


Study Acronym:

SAAGE


Brief Title:

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


Overall Status:

Enrolling by invitation


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Rochester


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

144


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Tristram H Smith, PhD
Principal Investigator
University of Rochester

Study Dates

Start Date:August 1, 2017
Completion Date:August 28, 2018
Completion Type:Anticipated
Primary Completion Date:August 28, 2018
Primary Completion Type:Anticipated
Verification Date:June 2018
Last Changed Date:June 18, 2018
First Received Date:June 6, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Class placement
Time Frame:baseline to end of school year (approx. 9 months)
Safety Issues:False
Description:IEP review
Outcome Type:Secondary Outcome
Measure:Social skills and behavior regulation
Time Frame:baseline to end of school year (approx. 9 months)
Safety Issues:False
Description:Social Skills Improvement System
Outcome Type:Secondary Outcome
Measure:School-related adaptive functioning
Time Frame:baseline to end of school year (approx. 9 months)
Safety Issues:False
Description:Adaptive Behavior Assessment System, Self-Direction Scale
Outcome Type:Secondary Outcome
Measure:Change in on-task behavior during instruction
Time Frame:baseline to end of school year (approx. 9 months)
Safety Issues:False
Description:Academic Engaged Time
Outcome Type:Secondary Outcome
Measure:Change in teacher-nominated target behaviors
Time Frame:baseline to end of school year (approx. 9 months)
Safety Issues:False
Description:Teacher Nominated Target Behaviors
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
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
Time Frame:baseline to end of school year (approx. 9 months)
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure: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)
Safety Issues:False
Description:The Developmental Disability-Clinical Global Assessment Scale ranges from 1-100 with 100 indicating superior functioning. It assesses student function in a classroom setting.

Study Interventions

Intervention Type:Other
Name:Enhanced Services As Usual
Description:Teaching staff access in-service presentations and print materials with no active study team coaching.
Arm Name:Enhanced Services As Usual
Intervention Type:Behavioral
Name:Students with Autism Accessing General Education
Description:With study team coach support, teacher implemented modules addressing student behavioral/academic goals.
Arm Name:Intervention

Study Arms

Study Arm Type:Active Comparator
Arm Name:Enhanced Services As Usual
Description: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.
Study Arm Type:Experimental
Arm Name:Intervention
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Rochester
Agency Class:Other
Agency Type:Collaborator
Agency Name:May Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 23, 2021

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