Clinical trial NCT06508515: Iterative Redesign of a Multifaceted Implementation Strategy for a School-based Behavioral Skills Intervention (RUBI)
Official title: Iterative Redesign of a Multifaceted Implementation Strategy for a School-based Behavioral Skills Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-07-18
Enrollment: 160
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.
* 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.

Primary outcomes:
measure: Aberrant Behavior Checklist-Irritability Scale (ABC-I)
timeFrame: Baseline, Week 12, Week 24
measure: Top Problems Assessment (TPA)
timeFrame: Baseline, Week 12, and Week 24
measure: Adoption
timeFrame: Baseline, Week 12, and Week 24
measure: Reach
timeFrame: Baseline, Week 12, and Week 24
measure: Sutter Eyberg Student Behavior Inventory
timeFrame: Baseline, Week 12, and Week 24
measure: 24-item Emotion Dysregulation Inventory
timeFrame: Baseline, Week 12, and Week 24
measure: Implementation Strategy Usability Scale (ISUS)
timeFrame: Week 12
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Week 12
Secondary outcomes:
measure: Fidelity
timeFrame: Weekly from Week 1 - Week 12
measure: Number of participants who complete the Framework for Modifications and Adaptations of Evidence Based Interventions
timeFrame: Baseline, Week 12, and Week 24
measure: Social Responsiveness Scale-2 (SRS-2)
timeFrame: Baseline
measure: Clinical Global Impressions (CGI)
timeFrame: Baseline, Week 12, and Week 24
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jill Locke, PhD
role: PRINCIPAL_INVESTIGATOR
References: