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Clinical Trials/NCT07276750
NCT07276750RecruitingNot Applicable

Coaching and Leadership in Autism Support Settings

University of California, Los Angeles1 site in 1 country373 target enrollmentStarted: February 1, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
373
Locations
1
Primary Endpoint
Reported Externalizing Behavior - SESBI-R

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
5 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

RUBIES + HELM

Experimental

Intervention: RUBIES (Other)

RUBIES + HELM

Experimental

Intervention: HELM (Other)

RUBIES

Experimental

Intervention: RUBIES (Other)

Psychoeducation

Active Comparator

Intervention: Educator Psychoeducation (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Sustainment(52 and 76 weeks after baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jill Locke, PhD

Associate Professor in Residence

University of California, Los Angeles

Study Sites (1)

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