RUBIES + HELM for Autism

(CLASS Trial)

Overseen By Jill J Locke, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

373 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for educators working with autistic children in schools. It aims to improve the use of evidence-based practices for managing externalizing behaviors and sustaining these practices over time.

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)

Autistic children who are enrolled with a participating educator

Exclusion Criteria

Autistic children with an EDI sum score less than 8

Autistic children with a SESBI-R total score less than 101 (i.e. T score 51+)

What Are the Treatments Tested in This Trial?

Interventions

• HELM
• RUBIES

Trial Overview The trial tests RUBIES, an intervention to reduce externalizing behaviors in autistic children, and HELM, a strategy to help sustain evidence-based practices by school leaders. The effectiveness of both will be measured.

How Is the Trial Designed?

Group I: RUBIES + HELM Experimental Treatment 2 Interventions

Group II: RUBIES Experimental Treatment 1 Intervention

Group III: Psychoeducation Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+