Recruiting

RUBIES & HELM

Sponsor:

UCLA

Code:

NCT07276750

Conditions

Autism Spectrum Disorder (ASD)

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Interventions

RUBIES

HELM

Educator Psychoeducation

Study Details

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.

Conditions

Autism Spectrum Disorder (ASD)

Study ID

NCT07276750

Start date

Feb 1, 2026

Status verified date

Sep, 2025

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

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 Design

Enrollment

373 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RUBIES + HELM

experimental: RUBIES

active comparator: Psychoeducation

Interventions

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.

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jill J Locke, PhD

818-384-3554locke@seis.ucla.edu

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90025

More Information

Sponsor

University of California, Los Angeles

Last update posted

Aug 21, 2026

Last verified

Sep, 2025

Keywords

  • implementation
  • schools
  • autism
  • behavior management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-08-21.