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Recruiting NCT07276750

Coaching and Leadership in Autism Support Settings

No phase Interventional Autism Spectrum Disorder (ASD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RUBIES, HELM, Educator Psychoeducation.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder (ASD). Basic parameters: from 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 Collaborati
  • 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 school

Primary outcome measures

  • Reported Externalizing Behavior - SESBI-R [Time frame: Baseline to 24 weeks after baseline]
  • Reported Externalizing Behavior- EDI [Time frame: Baseline to 24 weeks after baseline]
  • RUBIES Fidelity [Time frame: Baseline to 16 weeks after baseline]
Secondary outcome measures (1)
  • Sustainment [Time frame: 52 and 76 weeks after baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • UCLA — Los Angeles

Publications

  • Locke J, Williams NJ, Sridhar A, Shih W, Espeland C, Tagavi D, Bearss K. Study protocol for coaching and leadership in autism support settings: a cluster randomized controlled hybrid type 2 effectiveness-implementation trial. Implement Sci. 2026 Mar 28;21(1):32. doi: 10.1186/s13012-026-01497-0. PMID 41904557

Identifiers

NCT: NCT07276750 · IRB-25-1558 · US NIMH 1R01MH135924-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗