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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

RUBIES Trial Summary

This trial will test a new intervention for reducing disruptive behavior in elementary-school children with ASD, compared to usual care training. It will also examine how the intervention works, at the level of both the child and the person delivering the intervention.

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.Check my eligibility
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.See study design
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.

RUBIES Trial 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.

RUBIES Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Aberrant Behavior Checklist
Secondary outcome measures
Knowledge of Behavioral Principles
RUBIES fidelity
Student Behavior Observation

RUBIES 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

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
302 Previous Clinical Trials
5,216,484 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
7,833 Patients Enrolled for Autism Spectrum Disorder

Media Library

RUBIES Clinical Trial Eligibility Overview. Trial Name: NCT05093686 — N/A
Autism Spectrum Disorder Research Study Groups: Usual Care Treatment, RUBIES
Autism Spectrum Disorder Clinical Trial 2023: RUBIES Highlights & Side Effects. Trial Name: NCT05093686 — N/A
RUBIES 2023 Treatment Timeline for Medical Study. Trial Name: NCT05093686 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to still take part in this research opportunity?

"Data on clinicaltrials.gov reports that this research is open for recruitment, with the trial having been posted on August 1st 2021 and most recently modified on October 25th 2021."

Answered by AI

How many participants has this research project enrolled so far?

"Affirmative. Clinicaltrials.gov indicates that this medical trial, first posted on August 1st 2021, is actively recruiting participants. This venture requires a total of 240 individuals from one participating site."

Answered by AI

Who else is applying?

What state do they live in?
California
Florida
How old are they?
< 18
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
RUBIES in Educational Settings
Karen Bearss 2021. "RUBIES in Educational Settings". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05093686.
All > Asd > Autism
~15 spots leftby Jun 2024
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