Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 2:41 AM
Ignite Modification Date: 2025-12-25 @ 2:41 AM
NCT ID: NCT04199533
Brief Summary: This study proposes to redesign the RUBI Parent Training program, a low-intensity intervention for youth with autism spectrum disorder and disruptive behavior, for use by school personnel in the classroom. Using a mixed-methods approach, 40 school staff members from 20 elementary schools will be recruited to inform current classroom behavior management practices and RUBI redesign needs.
Detailed Description: Approximately 50% of children with autism spectrum disorder (ASD) exhibit disruptive behaviors such as tantrums, aggression, and noncompliance that significantly impact social, adaptive, and academic functioning. The RUBI program is an evidence-based parent-mediated intervention that improves disruptive behavior in children with ASD. Considering schools serve as the primary intervention setting for children with ASD, and teachers and school staff often struggle to address challenging behavior, there is an opportunity to meaningfully improve care by adapting RUBI for delivery in schools. To address these needs, the Discover, Design/Build, Test (DDBT) framework,which leverages user-centered design and implementation science, will be used to engage 40 end users from 20 elementary schools to inform current classroom behavior management practices and redesign needs for the RUBI curriculum to ensure that the modified curriculum (RUBI in Educational Settings; RUBIES) is useful and useable for school personnel who work with children with ASD. Specific aims include: Aim 1: Identify the contextual constraints and end users (teachers, school psychologists, behavior technicians, classroom aides) relevant to the management of disruptive behavior in the classroom. Through in-class behavioral observations and interviews, Aim 1 will allow us to understand the values and priorities of the school context and end users directly involved with children with ASD (e.g. resources, work flow, policies). Aim 2: Identify targets for RUBI redesign. Using in-depth intervention demonstration of RUBI paired with behavioral rehearsal, prospective think-aloud, and structured assessment methods, Aim 2 will allow us to determine which RUBI components should be retained, eliminated, or modified to address the needs of the context and end-users identified in Aim 1. Aim 3: Iteratively adapt RUBI content and procedures based on identified targets for redesign and continual user testing to improve the hypothesized mechanisms of redesign (usability) and perceptual implementation outcomes (feasibility, acceptability, and appropriateness). Aim 3 will allow us to determine the extent to which redesigned RUBI, or RUBIES, improves usability and implementation outcomes.
Study: NCT04199533
Study Brief:
Protocol Section: NCT04199533