Recruiting

Observational Study

Sponsor:

Seattle Children's Hospital

Code:

NCT05093686

Conditions

Autism Spectrum Disorder

Disruptive Behavior

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Interventions

RUBIES

Usual Care Training

Study Details

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

Study ID

NCT05093686

Start date

Oct 26, 2021

Status verified date

May, 2023

Completion date

Jul 31, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RUBIES

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

active comparator: Usual Care Treatment

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

Interventions

RUBIES

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).

Usual Care Training

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.

Primary outcome measure

  • Aberrant Behavior Checklist [ Time Frame: 24 Weeks ]

Central Contacts and Locations

Central contacts

Locations

Seattle Children's Research Institute

Recruiting

Seattle, Washington, United States, 98105

Contacts

More Information

Sponsor

Seattle Children's Hospital

Last update posted

May 8, 2023

Last verified

May, 2023

Keywords

  • autism
  • elementary schools
  • paraeducators
  • disruptive behavior

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2023-05-08.