NCT07276750 · University of California, Los Angeles
Coaching and Leadership in Autism Support Settings
(CLASS)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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.
OTHER
HELM
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.
OTHER
Educator 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.
Primary outcome measures
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.
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.
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Los Angeles, California
Collaborators
University of Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 7, 2026 · Source of record for eligibility and locations