RECRUITING

RUBIES in Educational Settings

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Exploring Mechanisms of Change in a Pilot Trial of the RUBI Program in Educational Settings

Quick Facts

Study Start:2021-10-26
Study Completion:2024-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05093686

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Paraeducators must be employed by the school district and work directly with children with ASD in the classroom at their school.
  2. * 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.
  1. * Paraeducator is not supporting a student with autism in a general education classroom
  2. * Student does not have a diagnosis of ASD or elevated disruptive behavior problems

Contacts and Locations

Study Contact

Karen Bearss, PhD
CONTACT
206-987-2880
karen.bearss@seattlechildrens.org

Study Locations (Sites)

Seattle Children's Research Institute
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Seattle Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-26
Study Completion Date2024-07-31

Study Record Updates

Study Start Date2021-10-26
Study Completion Date2024-07-31

Terms related to this study

Keywords Provided by Researchers

  • autism
  • elementary schools
  • paraeducators
  • disruptive behavior

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Disruptive Behavior