Behavioral Skills Intervention for Autism Spectrum Disorder

Overseen By Jill J Locke, PhD

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

Trial Summary

What is the purpose of this trial?

The increased prevalence of autism spectrum disorder (1 in 36 youth) in the United States along with the exorbitant cost of care of supporting one autistic individual with and without intellectual disability across their lifespan ($2.4 and $1.4 million, respectively) creates a sense of urgency to improve outcomes for autistic youth. Schools are the primary setting in which autistic children receive intervention. Despite a growing array of evidence-based interventions (EBI) such as behavioral management, EBIs often are unavailable in schools due to misalignment of existing implementation strategies (IS) with that setting. Large numbers of IS have been described for the education sector, but there is a dire need to identify the most efficient IS to support use of EBI in resource-strapped public schools. This project will apply the local Discover, Design/Build and Test (DDBT) framework to redesign and pilot a multifaceted IS to support educator use of a behavioral skills EBI for autistic children in public schools.

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 data supports the effectiveness of the treatment RUBI in Educational Settings (RUBIES)-Team for Autism Spectrum Disorder?

Research shows that group-based RUBI parent training led to improvements in children with autism and disruptive behaviors, with 64.7% of participants rated as much or very much improved. Additionally, parent coaching programs have been effective in low-resource settings, suggesting that parents can successfully deliver evidence-based treatments when properly trained. ^{1 2 3 4 5}

Is the RUBI program safe for humans?

The RUBI program, used for children with autism and disruptive behaviors, was tested in a small group study where most parents completed the trial and would recommend the treatment, suggesting it is generally safe. ^{1 3 6 7 8}

How is the RUBI treatment for autism spectrum disorder different from other treatments?

The RUBI treatment is unique because it involves training parents in group settings to manage disruptive behaviors in children with autism, making it more accessible and potentially more sustainable than individual therapy sessions. This approach emphasizes parent involvement and has shown promising results in improving child behavior, with a high rate of parent satisfaction and recommendation. ^{1 3 9 10 11}

Research Team

Jill Locke, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Group Parent Training for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Parent peer coaching program: A cascading intervention for parents of children with autism in Mongolia. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Behavioral intervention for preschool children with autism – outcome of parent-based Intervention]. [2019]

4. Brazil pubmed.ncbi.nlm.nih.gov

The effectiveness of early parental coaching in the autism spectrum disorder. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Dismantling the Active Ingredients of an Intervention for Children with Autism. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Naturalistic Developmental Behavioral Interventions: Empirically Validated Treatments for Autism Spectrum Disorder. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Using Prevent Teach Reinforce for Young Children to Manage Challenging Behaviors in Public Specialized Early Intervention Services for Autism. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Toward deeper understanding and wide-scale implementation of naturalistic developmental behavioral interventions. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Training Parents in Saudi Arabia to Implement Discrete Trial Teaching with their Children with Autism Spectrum Disorder. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Interventions for Repetitive Behavior in Young Children with Autism: A Survey of Behavioral Practices. [2020]

11. Canada pubmed.ncbi.nlm.nih.gov

Training care teams of children with autism spectrum disorders in positive behaviour support: an innovative approach. [2019]