RUBIES in Educational Settings

NCT05093686 | Unknown

• 1 other identifier: SCH-STUDY00003191
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed three-year pilot randomized trial aims to test the effectiveness of the newly-redesigned paraeducator-delivered RUBI for use in Educational Settings (RUBIES) intervention compared to usual care training in reducing disruptive behavior in 80 elementary-school children with ASD. Given the critical need to understand not just whether, but also how interventions work, this study also will examine paraeducator- and child-level mechanistic pathways of the RUBIES intervention.

Conditions

Autism Spectrum Disorder; Disruptive Behavior

Keywords

autism; elementary schools; paraeducators; disruptive behavior

Outcome Measures

Primary Outcomes (1)

• Aberrant Behavior Checklist

  After 24 weeks of treatment, students whose paraeducator received RUBIES will show greater reduction in classroom disruptive behavior as evidenced by reduction on the Aberrant Behavior Checklist Irritability Subscale compared to students whose paraeducator received Usual Care Treatment.

  24 Weeks

Secondary Outcomes (3)

• Knowledge of Behavioral Principles

  24Weeks

• RUBIES fidelity

  24 Weeks

• Student Behavior Observation

  24 Weeks

Study Arms (2)

RUBIES

EXPERIMENTAL

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

Behavioral: RUBIES

Usual Care Treatment

ACTIVE COMPARATOR

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

Behavioral: Usual Care Training

Interventions

RUBIES BEHAVIORAL

RUBIES is an 8 module intervention that begins with foundational education on ASD (Session1), followed by introducing basic applied behavior analysis principles (Session 2). Instruction is then provided on strategies that can prevent problematic behaviors from occurring (Session 3 and 4). Reinforcement (Session 5) reviews the use of tangible and social reinforcers tools to promote new/desired behaviors while planned ignoring and functional communication training (Session 6) teaches that disruptive behavior can serve as a form of communication while ignoring disruptive communicative attempts. Sessions conclude with instruction on effective ways to deliver commands to promote compliance (Session 7) and targeting approaches to ensure positive behavior gains can maintain over time and strategies can be used across classrooms and staff (Session 8).

Also known as: RUBI in Educational Settings

RUBIES

Usual Care Training BEHAVIORAL

Usual Care Training is an 8 module psychoeducation program that will provide foundational information on autism spectrum disorders, including the diagnostic criteria, appropriate educational services, common interventions, and how to promote social skills in the classroom.

Usual Care Treatment

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Paraeducators must be employed by the school district and work directly with children with ASD in the classroom at their school.
• Students with ASD will be included if they: 1) have a documented ASD diagnosis and a Social Responsiveness Scale-2 total raw score \> 70 for males and 65 for females; 2) are enrolled in a Kindergarten-5th grade general or special education classroom and participate in a general education classroom for a minimum of 4 hours/week; 3) have a participating paraeducator; 4) have a teacher-rated Aberrant Behavior Checklist-Irritability (ABC-I) subscale score \>15,; and 5) have a stable educational plan and placement.

You may not qualify if:

• Paraeducator is not supporting a student with autism in a general education classroom
• Student does not have a diagnosis of ASD or elevated disruptive behavior problems

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98105, United States

RECRUITING

Related Publications (1)

• Bearss K, Shih W, Tagavi DM, Kuo Y, Fettig A, Locke J. A Pilot Feasibility Randomized Trial of the RUBI in Educational Settings Intervention With Paraeducators Supporting Autistic Students in Public Elementary Schools. J Autism Dev Disord. 2025 Oct 15:10.1007/s10803-025-07072-8. doi: 10.1007/s10803-025-07072-8. Online ahead of print.

  PMID: 41091357 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Problem Behavior; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior

Central Study Contacts

Karen Bearss, PhD

CONTACT

206-987-2880; karen.bearss@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masked observers will complete the behavior observation of paraeducator use of RUBIES strategies (fidelity) and Behavior Observation of Students in School (BOSS; assessment of functional communication and classroom compliance) at all study points. Subject identity will be masked using numeric codes and only the principal investigator and research coordinator will have access to the password-protected master lists. Masked observers will receive identity coded videotapes to prevent unmasking of study condition or phase. Inclusion of UCT ensures that our behavior observation raters can remain masked to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Simple 1:1 random assignment will be used to assign half (n=40) of the paraeducator/teacher/child triads to remote training in RUBIES, allowing for personalized delivery and tailoring of RUBIES to the paraeducator-child dyad, and the other half (n=40 dyads) to Usual Care Training (UCT, an "Autism 101" attention control condition) over a three-year period. No greater than 10% paraeducator turnover each year is expected based on prior studies.

Study Record Dates

• First Submitted: October 3, 2021
• First Posted: October 26, 2021
• Study Start: October 26, 2021
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: May 8, 2023

Record last verified: 2023-05

Locations

US (1)