- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07276750
Coaching and Leadership in Autism Support Settings (CLASS)
April 6, 2026 updated by: Jill Locke, PhD, University of California, Los Angeles
Schools serve a large number of autistic children, yet face two critical gaps that stifle the delivery of evidence-based practices: 1) an intervention gap characterized by limited availability of evidence-based practices educators can use to address externalizing behaviors when they occur in the classroom; and 2) an implementation gap consisting of insufficient evidence-based practice fidelity and sustainment over time.
To address these gaps, this project proposes a hybrid type 2 effectiveness-implementation trial that simultaneously tests: 1) the clinical effectiveness of an efficient, educator-delivered clinical intervention to reduce autistic children's externalizing behaviors (Research Units in Behavioral Interventions in Educational Settings; RUBIES), and 2) the implementation effectiveness of an organizational implementation strategy designed specifically to enhance sustainment of evidence-based practices in public schools (Helping Educational Leaders Mobilize evidence; HELM).
Consistent with the National Institute of Mental Health (NIMH)'s experimental therapeutics approach, the project also examines the mechanisms through which RUBIES impacts clinical outcomes and through which HELM influences implementation outcomes.
The proposed study directly responds to high priority research areas of the US Department of Health and Human Services Interagency Autism Coordinating Committee's Strategic Plan for Autism Research, which calls for expanded research on the translation of proven-efficacious interventions into the community, NIMH Strategic Priority 3.3 to test interventions for effectiveness in community practice settings, and NIMH Strategic Priority 4.2 to expedite adoption, sustained implementation, and continuous improvement of evidence-based mental health services.
If successful, this study will have substantial public health impact because it will produce an effective intervention for a prevalent problem among a high impact population in schools across the United States of America and will determine how to sustain this (and other) intervention(s) with high fidelity, to the betterment of health.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
373
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jill J Locke, PhD
- Phone Number: 818-384-3554
- Email: locke@seis.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90025
- Recruiting
- UCLA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Special or general education teachers, paraeducators, and other staff who provide direct instruction and/or behavioral support to autistic children during the school day (e.g., speech therapist, school psychologist).
- Autistic children with:
- a documented autism spectrum disorder diagnosis via school records (i.e., Individualized Education Program; IEP)
- are enrolled with a participating educator
- are in grades K-5
- ages 5-12
- Sutter Eyberg Student Behavior Inventory-Revised (SESBI-R) total score >=101
- EDI sum score of >=8 at baseline
Exclusion Criteria:
- SESBI-R total score <101 (i.e. T score 51+)
- EDI sum score <8
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Psychoeducation
|
Autistic children in schools assigned to the educator psychoeducation condition will receive standard of care school-based interventions at the professional discretion and direction of educators (no research intervention).
To support enrollment and provide an active clinical comparator to RUBIES, participating educators in schools randomized to this condition will receive an online, self-paced, 8-module independent studies webinar program broadly focused on supporting autistic children in schools.
The program includes: 1) Introduction to Autism, 2) Autism in Schools, 3) Interventions for Supporting Communication, 4) Executive Functioning, 5) Inclusion in Schools, 6) Autism EBPs, 7) Social Functioning in Autism, and 8) Recess Engagement Strategies.
Each module is 20-35-minutes and does not discuss behavioral management strategies.
|
|
Experimental: RUBIES + HELM
|
RUBIES is a promising, but unvalidated, educator-delivered intervention that directly engages mechanistic antecedents of externalizing behavior of autistic children and is ready for large-scale testing.
RUBIES is an 8-module intervention designed to help educators functionally evaluate and understand behavior as communication and to account for autistic characteristics including rigidities and sensory sensitivities.
School principals and district-level leaders (e.g., Special Education Director, Special Education Administrator/Liaison, Inclusion Specialist, etc.) will participate in HELM.
HELM is a 9-month, data-driven organizational and leadership implementation strategy that entails eight components: 1) Assessment and Feedback, 2) Initial Training, 3) Leadership Development Plan, 4) Individual Coaching; 5) Organizational Strategy Development; 6) Optional Group Coaching; 7) Professional Learning Collaborative; and 8) Graduation.
|
|
Experimental: RUBIES
|
RUBIES is a promising, but unvalidated, educator-delivered intervention that directly engages mechanistic antecedents of externalizing behavior of autistic children and is ready for large-scale testing.
RUBIES is an 8-module intervention designed to help educators functionally evaluate and understand behavior as communication and to account for autistic characteristics including rigidities and sensory sensitivities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reported Externalizing Behavior - SESBI-R
Time Frame: Baseline to 24 weeks after baseline
|
The Sutter Eyberg Student Behavior Inventory-Revised (SESBI-R) is a teacher-report measure used to assess conduct problems in youth ages 2-16.
It contains 38 items where teachers are able to indicate the current frequency of behavior problems (Never to Always) and determine whether or not they find the behaviors to be problematic.
|
Baseline to 24 weeks after baseline
|
|
Reported Externalizing Behavior- EDI
Time Frame: Baseline to 24 weeks after baseline
|
The Emotion Dysregulation Inventory (EDI) is a questionnaire that assesses emotion regulation and is validated for youth with autism spectrum disorder (ASD).
Response options are on a 5-point Likert scale from "not at all" to "very severe" for observed functioning over the past 7 days.
|
Baseline to 24 weeks after baseline
|
|
RUBIES Fidelity
Time Frame: Baseline to 16 weeks after baseline
|
Educator Homework Completion is rated by the coach after the completion of each module, with evaluation focused on three domains, each evaluated on a 4-point scale: 1) homework data collection , 2) correct implementation, and 3) frequency.
Homework Completion is then calculated as the sum of coach ratings across the 3 domains/12 (total possible score).
Educator Behavior Support Plan (BSP) Implementation is rated by the Coach after the completion of each module on a scale of 1-8 (1=none of the components of the BSP are implemented; 4=BSP is partially implemented and with some implementation errors; 8=The BSP is implemented consistently and effectively in its entirety).
BSP Implementation is calculated as a proportion: sum of coach ratings/12 (total possible score).
These measures allow for a calculation of educator weekly as well as total average Homework Completion and BSP implementation across the course of RUBIES
|
Baseline to 16 weeks after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sustainment
Time Frame: 52 and 76 weeks after baseline
|
Sustainment is defined as 1) the level of fidelity to Research Units in Behavioral Interventions in Educational Settings (RUBIES) post coaching during the second year of study enrollment; and 2) an exploratory binary outcome where the educator achieves ≥60% in RUBIES fidelity ("1") or does not sustain RUBIES ("0").
Sustainment will focus on fidelity ratings of BSP Implementation.
|
52 and 76 weeks after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2026
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
August 31, 2030
Study Registration Dates
First Submitted
November 18, 2025
First Submitted That Met QC Criteria
December 10, 2025
First Posted (Actual)
December 11, 2025
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
April 6, 2026
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-25-1558
- US NIMH 1R01MH135924-01A1 (Other Grant/Funding Number: NIMH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The investigators will make data from our study available for access by the research community via NDAR on a semi-annual basis as set forth in the NDAR policy.
Data from descriptive measures will be submitted by July 15 and January 15 or the next business day, annually.
IPD Sharing Time Frame
The research community will have access to data when the award ends in 2030.
IPD Sharing Access Criteria
Data will be available in NDAR.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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