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

NCT06508515 | Recruiting

• 2 other identifiers: STUDY000172612P50MH115837-05
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (8)

• Aberrant Behavior Checklist-Irritability Scale (ABC-I)

  The 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.

  Baseline, Week 12, Week 24

• Top Problems Assessment (TPA)

  The Youth Top Problems (YTP) assessment is an assessment in which youth and caregivers are asked to list the problems they were most concerned about. Upon completion of the list, respondents are asked to assign a severity rating for each problem by answering the questions: how big of a problem is this for you? (0 = not at all to 10 = very, very much). Respondents are then asked to identify which of the problems listed is the biggest problem right now? Which one is the most important to work on? Then the second and third most important until 3 top problems are identified. The YTP shows excellent concurrence with standardized assessments (Kappa ranging from .78 to .91), while also adding specificity for treatment targets (41% of caregivers-, and 79% of youth-identified top problems were not identified by an item amongst elevated standardized assessment subscales).

  Baseline, Week 12, and Week 24

• Adoption

  Adoption 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.

  Baseline, Week 12, and Week 24

• Reach

  Reach will be calculated using adoption data as the number of students with whom educators use RUBIES.

  Baseline, Week 12, and Week 24

• Sutter Eyberg Student Behavior Inventory

  The 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.

  Baseline, Week 12, and Week 24

• 24-item Emotion Dysregulation Inventory

  The 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.

  Baseline, Week 12, and Week 24

• Implementation Strategy Usability Scale (ISUS)

  Usability 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.

  Week 12

• Intervention Appropriateness Measure (IAM)

  Educators 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).

  Week 12

Secondary Outcomes (4)

• Fidelity

  Weekly from Week 1 - Week 12

• Number of participants who complete the Framework for Modifications and Adaptations of Evidence Based Interventions

  Baseline, Week 12, and Week 24

• Social Responsiveness Scale-2 (SRS-2)

  Baseline

• Clinical Global Impressions (CGI)

  Baseline, Week 12, and Week 24

Study Arms (2)

Unadapted Research Units in Behavioral Intervention (RUBI) implementation strategy

ACTIVE COMPARATOR

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

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

RUBI in Educational Settings (RUBIES) implementation strategy

EXPERIMENTAL

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)

Behavioral: RUBI in Educational Settings (RUBIES)-Team

Interventions

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

Unadapted Research Units in Behavioral Intervention (RUBI) implementation strategy

RUBI in Educational Settings (RUBIES)-Team 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.

RUBI in Educational Settings (RUBIES) implementation strategy

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jill Locke, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Allred

CONTACT

(206) 616-9442; rallred@uw.edu

Katie Osterhage

CONTACT

(206) 616-2129; katieost@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 18, 2024
• Study Start: August 27, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (1)