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Completed

NCT Number: NCT06508515

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

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.

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Sutter Eyberg Student Behavior Inventory

    Time frame: Baseline, Week 12, and Week 24

    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.

  2. Fidelity

    Time frame: Week 12

    An independent evaluator will rate educators' use of RUBIES for participating autistic children.

Secondary outcomes

  1. Reach

    Time frame: Week 12

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

  2. Intervention Appropriateness Measure (IAM)

    Time frame: Week 12

    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).

  3. Implementation Strategy Usability Scale (ISUS)

    Time frame: Week 12

    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.

  4. 24-item Emotion Dysregulation Inventory

    Time frame: Baseline, Week 12, and Week 24

    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.

  5. Adoption

    Time frame: Week 12

    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.

  6. Aberrant Behavior Checklist-Irritability Scale (ABC-I)

    Time frame: Baseline, Week 12, Week 24

    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.

  7. Social Responsiveness Scale-2 (SRS-2)

    Time frame: Baseline

    The 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.

  8. Clinical Global Impressions (CGI)

    Time frame: Week 12

    The 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).

Other outcomes

  1. Top Problems Assessment (TPA)

    Time frame: Baseline, Week 12, Week 24

    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 4 = very big problem). 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).

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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