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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06508515
Enrollment
193
Registered
2024-07-18
Start date
2024-08-27
Completion date
2026-03-31
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

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.

Interventions

BEHAVIORALUnadapted 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.

BEHAVIORALRUBI 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.

Sponsors

University of Washington
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sutter Eyberg Student Behavior InventoryBaseline, Week 12, and Week 24The Sutter Eyberg Student Behavior Inventory is a teacher-report measure used to assess conduct problems in youth ages 2-16. It contains 36 items where teachers are able to indicate the current frequency of behavior problems (Never to Always) and determine whether or not they find the behaviors to be problematic.
FidelityWeek 12An independent evaluator will rate educators' use of RUBIES for participating autistic children.

Secondary

MeasureTime frameDescription
ReachWeek 12Reach will be calculated using adoption data as the number of students with whom educators use RUBIES.
Intervention Appropriateness Measure (IAM)Week 12Educators will complete the Intervention Appropriateness Measure (IAM), a rigorously developed, pragmatic 4-item instrument with strong good internal consistency (a = .87) and test-retest reliability (a = .87).
Implementation Strategy Usability Scale (ISUS)Week 12Usability will be evaluated with educator report on the 10-item Implementation Strategy Usability Scale (ISUS), which is based closely on the well-validated System Usability Scale. Ratings are on a 1 to 5 scale and yield a total score from 0 to 100. Half the items are reverse scored; higher total scores reflect greater usability. The ISUS has good inter-item consistency (a = .83) and sensitivity. Research has also demonstrated that the original version of the ISUS (the SUS) functions similarly-and yields similar scores-for adults and youth as young as 11 years.
24-item Emotion Dysregulation InventoryBaseline, Week 12, and Week 24The Emotion Dysregulation Inventory (EDI) is a questionnaire that assesses emotion regulation and is validated for youth with autism spectrum disorder (ASD). Response options are on a 5-point Likert scale from "not at all" to "very severe" for observed functioning over the past 7 days.
AdoptionWeek 12Adoption is operationalized as the initiation of a educator first use of RUBIES or RUBI at any point during study participation. These data will be collected from educators.
Aberrant Behavior Checklist-Irritability Scale (ABC-I)Baseline, Week 12, Week 24The Aberrant Behavior Checklist-Irritability Scale (ABC-I) is a 15-item, teacher-rated subtest on the ABC. Each item is rated 0-3 with higher scores indicating greater severity.
Social Responsiveness Scale-2 (SRS-2)BaselineThe Social Responsiveness Scale-2 (SRS-2,) a 65-item rating scale that measures social behavior associated with ASD. The SRS-2 has been widely used to distinguish children with a pervasive developmental disorder from those with other psychiatric conditions. The SRS-2 is used for children 4-18 years old.
Clinical Global Impressions (CGI)Week 12The Clinical Global Impressions Scale (CGI) is a clinician-rated mental health assessment tool used to establish global improvement or change following care, treatment or intervention (CGIC). CGIC scores range from 1 (very much improved) through to 7 (very much worse).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJill Locke, PhD

University of Washington

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026