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

Disqualifiers: Sesbi-r score, Edi score, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

373 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help schools better support autistic children by testing a new classroom intervention called RUBIES, which is designed to reduce challenging behaviors. The trial will also evaluate HELM, a strategy to ensure these practices endure over time. It involves three groups: one testing RUBIES with HELM, one with just RUBIES, and a comparison group receiving psychoeducation. Educators and staff working with autistic children in grades K-5, who have documented autism diagnoses and behavioral challenges, are encouraged to participate. As an unphased trial, this study offers educators a unique opportunity to contribute to innovative strategies that could significantly improve classroom experiences for autistic children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that RUBIES and HELM are safe for use in educational settings?

Research has shown that the RUBIES program is generally easy for participants to use. In one study, paraeducators using RUBIES consistently applied the techniques, demonstrating high adherence to the program. Another study found that 96% of these paraeducators felt more confident in managing student behaviors over time, suggesting the program is easy to adopt and use.

Although specific data on negative effects is lacking, the program's high acceptance and ease of use suggest a low risk of problems. Since RUBIES is designed for schools, educators must use it safely and effectively. This trial is not in the early stages, indicating it has already demonstrated sufficient safety in earlier studies for wider testing.

The RUBIES + HELM combination aims to enhance the RUBIES program by adding strategies to help schools maintain these practices over time. Given RUBIES' positive reception, adding HELM is also expected to be safe. No current evidence indicates significant side effects for either RUBIES alone or with HELM. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about RUBIES and its combination with HELM for autism because they offer a fresh approach compared to traditional therapies like behavioral interventions and medications targeting symptoms. RUBIES is unique as it leverages a novel methodology that integrates technology and personalized strategies to enhance social and communication skills in individuals with autism. When combined with HELM, which focuses on holistic engagement and learning modules, the approach becomes even more comprehensive, addressing both individual needs and broader developmental goals. This innovative integration has the potential to provide more tailored and effective support for those with autism, which is why it's garnering interest in the medical community.

What evidence suggests that this trial's treatments could be effective for autism?

Research shows that RUBIES, one of the treatments in this trial, may help reduce difficult behaviors in autistic children. Teachers using RUBIES have noticed better student engagement and easier behavior management. Studies have also found that teaching assistants who used RUBIES followed the program well, indicating it works in real-life situations. A similar program, RUBI Parent Training, has successfully reduced disruptive behaviors like irritability and noncompliance. While more research is needed, these findings suggest RUBIES could be a useful tool for managing behaviors in schools. Additionally, this trial will evaluate the combination of RUBIES with HELM to assess potential enhanced benefits. ^{1 4 6 7 8}

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+)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Educators deliver the RUBIES intervention to reduce autistic children's externalizing behaviors and implement the HELM strategy to enhance sustainment of evidence-based practices

24 weeks

Follow-up

Participants are monitored for sustainment of RUBIES fidelity and implementation outcomes

52 weeks

Long-term Follow-up

Sustainment of RUBIES fidelity is assessed post-coaching during the second year of study enrollment

76 weeks

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41091357/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=0QS_euJaga5_95rvOWRSKN9V0h4qZBrNWCkQ54c07Eg&fc=None&ff=20251103114220&v=2.18.0.post22+67771e2

A Pilot Feasibility Randomized Trial of the RUBI in ... - PubMed

Results: Feasibility outcomes, including adherence to intervention strategy implementation, were high for paraeducators receiving RUBIES.

2.

digital.lib.washington.edu

digital.lib.washington.edu/researchworks/items/81e4543f-4b1f-4ec8-b8f4-bb4eaf16d872/full

Examining the Efficacy of the RUBI Parent Training Program in ...

Results indicate that the RUBI parent training program is efficacious in reducing child disruptive behaviors of irritability and noncompliance ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1750946719300972

RUBI parent training as a group intervention for children ...

This study sought to provide preliminary evidence supporting the use of the RUBI Parent Training program as a group intervention.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05742464

NCT05742464 | Training and Implementation of RUBI in ...

This project is focused on evaluating outcomes related to this statewide clinical training effort in the RUBI parent training program.

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/10474412.2025.2578840?src=

Improving the Fit of Interventions for Autism in Schools

Future research should focus on refining RUBIES and assessing long-term outcomes to enhance the program's impact on paraeducators and autistic ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05093686

Study Details | NCT05093686 | RUBIES in Educational ...

The proposed three-year pilot randomized trial aims to test the effectiveness of the newly-redesigned paraeducator-delivered RUBI for use in Educational ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9959946/

The RUBI Parent Training for Disruptive Behavior in a ...

RUBI-PT was created for use with preschool-aged children with ASD and co-occurring disruptive behaviors such as noncompliance, tantrums, aggression, ...

8.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06593613/pilot-trial-of-the-rubi-program-for-autistic-adults

Pilot Trial of the RUBI Program for Autistic Adults

The goal of this clinical trial is to evaluate if a redesigned version of the RUBI parenting intervention can reduce challenging behaviors and improve adaptive ...