Iterative Redesign of a Multifaceted Implementation Strategy for a School-based Behavioral Skills Intervention (RUBI)

NCT ID: NCT06508515

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-27
• Study Completion Date: 2026-03-31

Brief Summary

The increased prevalence of autism spectrum disorder (1 in 36 youth) in the United States along with the exorbitant cost of care of supporting one autistic individual with and without intellectual disability across their lifespan ($2.4 and $1.4 million, respectively) creates a sense of urgency to improve outcomes for autistic youth. Schools are the primary setting in which autistic children receive intervention. Despite a growing array of evidence-based interventions (EBI) such as behavioral management, EBIs often are unavailable in schools due to misalignment of existing implementation strategies (IS) with that setting. Large numbers of IS have been described for the education sector, but there is a dire need to identify the most efficient IS to support use of EBI in resource-strapped public schools. This project will apply the local Discover, Design/Build and Test (DDBT) framework to redesign and pilot a multifaceted IS to support educator use of a behavioral skills EBI for autistic children in public schools.

Detailed Description

Specifically, this study will test the effects of the newly redesigned Research Units in Behavioral Intervention in Educational Settings (RUBIES) Implementation Strategy in comparison with the unadapted Research Units in Behavioral Intervention (RUBI) Implementation Strategy on DDBT mechanisms (engagement, usability, appropriateness), proximal implementation outcomes (adoption, fidelity, adaptation, reach) and child outcomes (disruptive behavior, functioning, top problems). Compared with the un-adapted RUBI IS, the newly designed implementation strategy RUBIES-Team will lead to:

H3-1: greater RUBIES usability, engagement, and appropriateness; H3-2: greater RUBIES adoption, fidelity, and reach, with fewer reactive adaptations to the RUBIES IS; H3-3: noninferiority on student disruptive behavior in autistic children; and H3-4: more students with improved behavioral outcomes than deterioration or unchanged outcomes across conditions.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Unadapted Research Units in Behavioral Intervention (RUBI) implementation strategy

Participants in this arm will receive the un-adapted RUBI implementation strategy (i.e., RUBI as usual).

Group Type: ACTIVE_COMPARATOR

Unadapted Research Units in Behavioral Intervention (RUBI) implementation strategy

Intervention Type: BEHAVIORAL

The unadapted RUBI IS involves weekly, one hour educational meetings where sessions involve discussion of homework from the week prior (5 minutes), didactic instruction on targeted behavioral strategies (40 minutes), coaching and consultation around the newly learned strategy (10 minutes), and fidelity review, where RUBI implementation is observed (5 minutes). Finally, Attend\| Behavior® is a HIPAA-compliant mobile application support that is designed to support RUBI delivery and implementation.

RUBI in Educational Settings (RUBIES) implementation strategy

Participants in this arm will receive an adapted version of the RUBI intervention manual that was iteratively redesigned for use in educational settings (i.e., RUBI for Educational Settings; RUBIES)

Group Type: EXPERIMENTAL

RUBI in Educational Settings (RUBIES)-Team

Intervention Type: BEHAVIORAL

RUBIES is an 8-module intervention that provides educators a range of skills to support the building of a behavioral management toolbox to be used, as needed, with autistic children and disruptive behavior. The program emphasizes: 1) tailoring the intervention to the specific child; 2) identifying behavioral function instead of topography as a means to inform behavioral strategy choice; 3) decreasing behavioral excess as well as increasing appropriate behaviors; and 4) using positive behavioral supports, such as antecedent management (e.g., use of visual supports), reinforcement, and functional communication strategies to modify behaviors. All educators will receive RUBIES training across 24 weeks via Zoom.

Interventions

Unadapted Research Units in Behavioral Intervention (RUBI) implementation strategy

The unadapted RUBI IS involves weekly, one hour educational meetings where sessions involve discussion of homework from the week prior (5 minutes), didactic instruction on targeted behavioral strategies (40 minutes), coaching and consultation around the newly learned strategy (10 minutes), and fidelity review, where RUBI implementation is observed (5 minutes). Finally, Attend\| Behavior® is a HIPAA-compliant mobile application support that is designed to support RUBI delivery and implementation.

Intervention Type: BEHAVIORAL

RUBI in Educational Settings (RUBIES)-Team

RUBIES is an 8-module intervention that provides educators a range of skills to support the building of a behavioral management toolbox to be used, as needed, with autistic children and disruptive behavior. The program emphasizes: 1) tailoring the intervention to the specific child; 2) identifying behavioral function instead of topography as a means to inform behavioral strategy choice; 3) decreasing behavioral excess as well as increasing appropriate behaviors; and 4) using positive behavioral supports, such as antecedent management (e.g., use of visual supports), reinforcement, and functional communication strategies to modify behaviors. All educators will receive RUBIES training across 24 weeks via Zoom.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Elementary School Personnel. Elementary school personnel must be 18+ and employed by the school district and work directly with autistic students at their school. Elementary school personnel with varying levels of experience and training backgrounds will be included. Participants will not be excluded given their gender identity, age, demographics, racial/ethnic background, or past experience.

Exclusion Criteria

• Students will be excluded from this study if they are not planning to stay in the school or the classroom for the duration of the study. Participants will not be excluded given their gender identity, demographics, racial/ethnic background, or ASD symptomology or behavior.

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jill Locke

Associate Professor, Department of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jill Locke, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ryan Allred

Role: CONTACT

rallred@uw.edu

(206) 616-9442

Katie Osterhage

Role: CONTACT

katieost@uw.edu

(206) 616-2129

Facility Contacts

Jill J Locke, PhD

Role: primary

Other Identifiers

2P50MH115837-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00017261

Identifier Type: -

Identifier Source: org_study_id