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

University of Washington

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Unadapted Research Units in Behavioral Intervention (RUBI) implementation strategy; Behavioral: RUBI in Educational Settings (RUBIES)-Team

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06508515

STUDY00017261

2P50MH115837-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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.
• Autistic Children who work with a Elementary School Personnel. To participate, autistic students must be between the ages of 5-12 from a participating public elementary school who: (1) have school documentation of an autism classification which will be confirmed through caregiver provision of documentation of a confirmed ASD diagnosis and a score that is above the mean on either the Emotion Dysregulation Inventory or the Sutter Eyberg Student Behavior Inventory; (2) be enrolled in a Kindergarten-5th grade general or special education classroom and participate in an inclusive classroom setting for a minimum of 10% of their weekly hours (4 hours/week); (3) have a participating educator enrolled that meets the inclusion criteria for Elementary School Personnel

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.
• Elementary School Personnel will be excluded if they are not working with an autistic student who meets the inclusion criteria.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Unadapted Research Units in Behavioral Intervention (RUBI) implementation strategy

Active Comparator group

Description:

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

Treatment:

Behavioral: Unadapted Research Units in Behavioral Intervention (RUBI) implementation strategy

RUBI in Educational Settings (RUBIES) implementation strategy

Experimental group

Description:

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)

Treatment:

Behavioral: RUBI in Educational Settings (RUBIES)-Team