What side effects are associated with this type of intervention?

Behavioral interventions for Autism Spectrum Disorder (ASD), such as those similar to the RUBIES trial, generally have minimal physical side effects. However, they can sometimes lead to increased stress or frustration for both the child and the caregiver if not implemented correctly. Other common treatments for ASD, such as Applied Behavior Analysis (ABA) and the Early Start Denver Model (ESDM), may also cause temporary increases in challenging behaviors as children adjust to new routines and expectations. It is important for caregivers and therapists to monitor the child's response and adjust the intervention strategies as needed to minimize any negative impacts.

What prior FDA approvals exist?

The FDA has approved two medications specifically for the treatment of irritability associated with Autism Spectrum Disorder (ASD): risperidone and aripiprazole. These medications are used to manage symptoms such as aggression, self-injury, and severe tantrums. While the RUBIES trial focuses on behavioral interventions to reduce disruptive behavior in children with ASD, these medications can be part of a comprehensive treatment plan that includes both pharmacologic and behavioral strategies.

What other types of research exist?

Promising alternatives to RUBIES for treating ASD in 2024 include: 1) Camp Discovery, a mobile application based on applied behavior analysis, which has shown significant gains in teaching receptive language skills to children with ASD. 2) Telehealth-based parent training programs, which have demonstrated feasibility and effectiveness in managing disruptive behaviors in children with ASD, especially in rural areas. 3) Prevent-Teach-Reinforce-for-Young-Children (PTR-YC) program, which has been effective in addressing challenging behaviors within early intensive behavioral intervention services.

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RUBIES Intervention for Autism (RUBIES Trial)

N/A

Recruiting

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Paraeducators must be employed by the school district and work directly with children with ASD in the classroom at their school

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the RUBIES program, which trains school staff to manage disruptive behaviors in elementary-school children with autism. The goal is to create a more supportive learning environment by teaching effective behavior management techniques. The RUBI program was initially developed for parents of children with autism spectrum disorder (ASD) and challenging behavior in clinic settings.

Who is the study for?

This trial is for elementary-school children with Autism Spectrum Disorder (ASD) who show disruptive behavior. They must be in K-5th grade, spend at least 4 hours a week in general education, have an ASD diagnosis with certain test scores, and exhibit irritability above a set threshold. Their educational plan should be stable, and they need to have a paraeducator willing to participate.

What is being tested?

The study compares the RUBIES intervention—a program delivered by paraeducators—to usual care training for managing disruptive behaviors in kids with ASD. The goal is to see if RUBIES can reduce these behaviors more effectively than standard practices.

What are the potential side effects?

Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected. However, there may be changes in behavior or emotional responses as participants adjust to new strategies used during the intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I work in a school and directly help children with ASD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aberrant Behavior Checklist

Secondary study objectives

Knowledge of Behavioral Principles

RUBIES fidelity

Student Behavior Observation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RUBIESExperimental Treatment1 Intervention

RUBIES provides paraeducators in training on behavioral strategies based on principles of applied behavior analysis to target student disruptive behaviors in the classroom

Group II: Usual Care TreatmentActive Control1 Intervention

Usual Care Treatment provides paraeducators with foundational psychoeducation on autism spectrum disorders.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RUBIES

2019

N/A

~40

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral interventions for Autism Spectrum Disorder (ASD), such as Applied Behavior Analysis (ABA), work by using reinforcement strategies to improve social, communication, and learning skills. These methods involve breaking down tasks into smaller steps and using positive reinforcement to encourage desired behaviors. This approach is essential for ASD patients as it targets core symptoms and helps reduce disruptive behaviors, thereby enhancing their overall quality of life and functional abilities.

Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis.What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials.Commentary: Randomized controlled trials in autism spectrum disorder: state of the field and challenges for the future.