Behavioral Skills Intervention for Autism Spectrum Disorder

Overseen By Katie Osterhage

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Not staying in school

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

Compensation: Varies

Number of Visits: 12

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance how schools assist autistic children by testing two methods of implementing a behavioral skills program called RUBI (Research Units in Behavioral Intervention). One method uses the standard program, while the other adapts it specifically for school settings, known as RUBI in Educational Settings (RUBIES)-Team. The goal is to determine the most effective way to support educators in applying these interventions in public schools. The trial seeks elementary school educators who work directly with autistic students and autistic children aged 5–12 attending participating public elementary schools. As an unphased trial, this study provides a unique opportunity to contribute to innovative educational strategies that could transform support for autistic students.

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 this behavioral skills intervention is safe for autistic children in educational settings?

Research has shown that the RUBI program, which stands for Research Units in Behavioral Intervention, is a well-accepted method for helping autistic children. The program has been effectively used with parents to reduce disruptive behaviors in children with autism. Studies have found that parents who participated in this training saw better results compared to those who received traditional education, indicating that the program is safe and helpful for children.

The RUBIES version, a modified form of the RUBI program specifically created for schools, has shown early promise. Initial findings suggest that RUBIES is practical and well-received by teachers working with autistic students. Although more research is needed to confirm these findings, the initial results are encouraging.

Overall, both the original RUBI program and the RUBIES version are considered safe and well-received. They aim to help children through structured support and behavior management techniques. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RUBI in Educational Settings (RUBIES) intervention because it adapts a successful behavioral strategy specifically for use in schools, where many children with Autism Spectrum Disorder (ASD) spend a significant amount of their day. Unlike traditional RUBI strategies, which are typically implemented in clinical settings, RUBIES is redesigned to fit seamlessly into educational environments, making it more accessible for teachers and school staff to apply. This adaptation could lead to more consistent and widespread support for children with ASD in their everyday learning environments, potentially improving their social and behavioral outcomes.

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

Research has shown that the RUBI Parent Training program effectively reduces disruptive behavior in children with autism. Large studies have found that RUBI significantly lowers disruptive behavior and outperforms mere parental education. Parents value the program for its straightforward and organized approach. In this trial, participants will receive either the standard RUBI implementation strategy or the RUBIES version, which adapts RUBI for school use. This adaptation could enhance its impact and accessibility. Overall, RUBI has a strong history of helping manage autism-related challenges at home and in school. ^{1 6 7 8 9}

Who Is on the Research Team?

Jill Locke, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for educators in public schools who work with autistic children. The goal is to improve the use of behavioral skills interventions (EBI) in educational settings, addressing the urgent need for effective autism support.

Inclusion Criteria

I am over 18, work with autistic students, and am employed by a school district.

I am an autistic student aged 5-12, with confirmed ASD and struggle with managing emotions or behavior, attending K-5th grade, spending some time in inclusive classes, and my teacher is participating.

Exclusion Criteria

Students not planning to stay in the school or classroom for the duration of the study

I work at an elementary school but not with autistic students.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation Strategy Testing

Testing the effects of the newly redesigned RUBIES Implementation Strategy compared to the unadapted RUBI Implementation Strategy

12 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after the implementation strategy testing

12 weeks

Visits at Week 12 and Week 24

What Are the Treatments Tested in This Trial?

Interventions

• RUBI in Educational Settings (RUBIES)-Team
• Unadapted Research Units in Behavioral Intervention (RUBI) implementation strategy

Trial Overview

The study tests a redesigned implementation strategy called RUBIES-Team, compared to an unadapted strategy, aiming to better integrate EBIs like RUBI into schools for autistic youth.

How Is the Trial Designed?

Group I: RUBI in Educational Settings (RUBIES) implementation strategy Experimental Treatment 1 Intervention

Participants in this arm will receive an adapted version of the RUBI intervention manual that was iteratively redesigned for use in educational settings (i.e., RUBI for Educational Settings; RUBIES)

Group II: Unadapted Research Units in Behavioral Intervention (RUBI) implementation strategy Active Control 1 Intervention

Participants in this arm will receive the un-adapted RUBI implementation strategy (i.e., RUBI as usual).

RUBI in Educational Settings (RUBIES)-Team is already approved in United States for the following indications:

Approved in United States as RUBI for:

• Autism Spectrum Disorder (ASD) with co-occurring disruptive behavior

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A community-based model of Early Intensive Behavioral Intervention (EIBI) for children with autism, where parents act as primary therapists, showed significant improvements in children's developmental scores after one year of intervention, indicating its potential effectiveness.

The study involved 13 children aged 2 to 5 years and demonstrated that while children's autism symptoms decreased, parental stress levels remained stable, suggesting that this model may be manageable for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Behavioral intervention for preschool children with autism – outcome of parent-based Intervention]. Molnár, C., Eldevik, S.[2019]

A workshop designed for parents and teams to address the behavioral needs of children with autism using a positive behavior support (PBS) approach showed promising results, indicating it is an effective intervention.

Participants reported significant improvements in implementing strategies learned during the workshops, suggesting that this model can help teams overcome communication challenges when managing problem behaviors in children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training care teams of children with autism spectrum disorders in positive behaviour support: an innovative approach. Reynolds, S., Lynch, SL., Litman, S.[2019]

Naturalistic Developmental Behavioral Interventions (NDBI) combine applied behavioral and developmental sciences to support early autism diagnosis and intervention, emphasizing the importance of teaching skills in natural settings.

NDBIs involve shared control between the child and therapist and utilize natural consequences to promote developmentally appropriate skills, highlighting the need for further research to clarify and improve these interventions for families and service providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naturalistic Developmental Behavioral Interventions: Empirically Validated Treatments for Autism Spectrum Disorder. Schreibman, L., Dawson, G., Stahmer, AC., et al.[2022]

The Prevent-Teach-Reinforce-for-Young-Children (PTR-YC) program was successfully implemented in community settings, showing small to moderate improvements in challenging behaviors among children with autism and reduced parenting stress across 35 families.

The study demonstrated strong recruitment and retention rates, along with high implementation fidelity and positive feedback from parents, indicating that a larger multi-center randomized controlled trial could be feasible and beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Prevent Teach Reinforce for Young Children to Manage Challenging Behaviors in Public Specialized Early Intervention Services for Autism. Rivard, M., Mello, C., Mestari, Z., et al.[2021]

A survey of 128 behavior analysts revealed that most believe the interventions they use for treating rigid and repetitive behaviors in young children with autism spectrum disorder (ASD) are effective in creating lasting behavior changes.

The analysts showed similar views on the effectiveness of reinforcement-based and punishment-based practices, indicating a consensus on the approaches used for addressing these behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for Repetitive Behavior in Young Children with Autism: A Survey of Behavioral Practices. Raulston, TJ., Hansen, SG., Machalicek, W., et al.[2020]

Naturalistic Developmental Behavioral Interventions (NDBIs) are effective early interventions for children on the autism spectrum, but they are not widely used in practice due to various barriers.

The paper outlines common features of NDBIs, addresses misconceptions, and emphasizes the need for better training and support for practitioners to promote their broader implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward deeper understanding and wide-scale implementation of naturalistic developmental behavioral interventions. D'Agostino, SR., Dueñas, AD., Bravo, A., et al.[2023]

An open feasibility trial of group-based RUBI parent training involved 18 children with autism spectrum disorder (ASD) and showed that 64.7% of participants were rated as much or very much improved after 24 weeks, indicating promising preliminary efficacy.

The high completion rate of 83% and strong therapist fidelity (98.8%) suggest that group interventions could be a viable and effective approach for delivering support to families of children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Group Parent Training for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot. Burrell, TL., Postorino, V., Scahill, L., et al.[2021]

In a study involving 191 children with autism aged 5-8, low fidelity to the STAR program components was observed, indicating a need for improved implementation strategies despite training efforts.

Fidelity to pivotal response training was linked to cognitive gains, suggesting it could be a beneficial intervention even in settings with limited resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dismantling the Active Ingredients of an Intervention for Children with Autism. Pellecchia, M., Connell, JE., Beidas, RS., et al.[2019]

In a study conducted in Mongolia with four parent mentors and five parent peers, it was found that trained parents can effectively deliver evidence-based treatment strategies to support children with autism, even in low-resource settings.

The involvement of local organizations and bilingual research assistants was crucial in adapting and implementing the intervention, highlighting the importance of community engagement in enhancing the feasibility and acceptability of autism support programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent peer coaching program: A cascading intervention for parents of children with autism in Mongolia. Lee, JD., Meadan, H., Oyunbaatar, E.[2022]

In a study involving 18 children with Autism Spectrum Disorder, those who received 12 weeks of Parental Coaching showed significantly greater improvements in developmental skills compared to a control group that did not receive any specialized training.

The Parental Coaching, based on the Early Start Denver Model, enhanced not only the children's skills in areas like communication and social interaction but also improved the quality of parent-child interactions, suggesting it as an effective early intervention strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of early parental coaching in the autism spectrum disorder. Malucelli, ERS., Antoniuk, SA., Carvalho, NO.[2022]

A behavioral skill training package significantly improved the ability of three mothers to implement discrete trial teaching techniques with their children who have autism spectrum disorder.

The training not only enhanced the mothers' teaching skills but also led to positive changes in their children's behavior, demonstrating the effectiveness and lasting impact of the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training Parents in Saudi Arabia to Implement Discrete Trial Teaching with their Children with Autism Spectrum Disorder. Eid, AM., Aljaser, SM., AlSaud, AN., et al.[2020]

Citations

1.

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.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8934264/

Iterative Redesign of a Caregiver Mediated Intervention for ...

The RUBI program is an evidence-based, low-intensity manualized intervention, initially developed for parents of autistic children ages 3–14 and co-occurring ...

3.

cebc4cw.org

cebc4cw.org/program/rubi-parent-training/

CEBC » Program › Rubi Parent Training

The purpose of the study was to evaluate the efficacy of Parent Training [now called RUBI Parent Training (RUBI-PT)] for children with autism spectrum disorder ...

4.

ctv.veeva.com

ctv.veeva.com/study/rubies-in-educational-settings

RUBIES in Educational Settings - ClinicalTrials.Veeva

Results across three large scale trials have demonstrated that RUBI significantly reduces child disruptive behavior, and treatment recipients ...

5.

pmc.ncbi.nlm.nih.gov

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

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

In randomized trials, RUBI-PT was found to be superior to parent education in reducing disruptive behavior and noncompliance, being acceptable ...

6.

researchgate.net

researchgate.net/publication/396516538_A_Pilot_Feasibility_Randomized_Trial_of_the_RUBI_in_Educational_Settings_Intervention_With_Paraeducators_Supporting_Autistic_Students_in_Public_Elementary_Schools

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

Conclusion Findings suggest that RUBIES is a feasible and acceptable intervention for paraeducators, though further research is needed to assess ...

7.

rubinetwork.org

rubinetwork.org/

The RUBI Autism Network

RUBI Autism Network is a team of experts in the field of autism spectrum disorder located at five university based medical centers.

8.

jadehealth.org

jadehealth.org/learning-hub/rubi-parent-training-program-for-autistic-youth-with-challenging-behaviors/

RUBI Parent Training for Autistic Youth with Behaviors

Research indicates that a 24-week RUBI program significantly outperforms traditional parent education in reducing disruptive behaviors, offering ...

9.

link.springer.com

link.springer.com/article/10.1007/s10880-023-09949-1

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

The current case report demonstrates the utility of RUBI-PT in the treatment of behavioral difficulties in a patient with ASD, ADHD, and ESES.