- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04199533
Iterative Redesign of a Behavioral Skills Training Program for Use in Educational Settings
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Approximately 50% of children with autism spectrum disorder (ASD) exhibit disruptive behaviors such as tantrums, aggression, and noncompliance that significantly impact social, adaptive, and academic functioning. The RUBI program is an evidence-based parent-mediated intervention that improves disruptive behavior in children with ASD. Considering schools serve as the primary intervention setting for children with ASD, and teachers and school staff often struggle to address challenging behavior, there is an opportunity to meaningfully improve care by adapting RUBI for delivery in schools. To address these needs, the Discover, Design/Build, Test (DDBT) framework,which leverages user-centered design and implementation science, will be used to engage 40 end users from 20 elementary schools to inform current classroom behavior management practices and redesign needs for the RUBI curriculum to ensure that the modified curriculum (RUBI in Educational Settings; RUBIES) is useful and useable for school personnel who work with children with ASD. Specific aims include:
Aim 1: Identify the contextual constraints and end users (teachers, school psychologists, behavior technicians, classroom aides) relevant to the management of disruptive behavior in the classroom. Through in-class behavioral observations and interviews, Aim 1 will allow us to understand the values and priorities of the school context and end users directly involved with children with ASD (e.g. resources, work flow, policies).
Aim 2: Identify targets for RUBI redesign. Using in-depth intervention demonstration of RUBI paired with behavioral rehearsal, prospective think-aloud, and structured assessment methods, Aim 2 will allow us to determine which RUBI components should be retained, eliminated, or modified to address the needs of the context and end-users identified in Aim 1.
Aim 3: Iteratively adapt RUBI content and procedures based on identified targets for redesign and continual user testing to improve the hypothesized mechanisms of redesign (usability) and perceptual implementation outcomes (feasibility, acceptability, and appropriateness). Aim 3 will allow us to determine the extent to which redesigned RUBI, or RUBIES, improves usability and implementation outcomes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98105
- Seattle Public Schools
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Elementary school (kindergarten through 5th grade) personnel (i.e. general and special education teachers, school psychologist, paraprofessionals)
- Works with at least one student with ASD for part of the day
Exclusion Criteria:
-School personnel who do not have contact with youth with ASD during the work day
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Classroom Observation
The investigators will use day-long observational and interview procedures with eight staff from four schools.
The classroom observation will focus on documenting episodes of classroom disruptive behavior, including antecedents and consequences to the behaviors.
The interview will involve discussing with staff decision-making processes and current needs around classroom behavioral management.
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RUBI Redesign
Two separate demonstration studies comprising 6 staff members each will focus on informing adaptation or pruning needs related to RUBI content and structure to ensure the redesigned curriculum (RUBIES) is contextually appropriate for schools.
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Parent-mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis
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RUBIES Collaborative Design
Eight staff from 4 schools will attend one of four 2-hour in-person feedback sessions to support collaborative feedback around RUBI redesign, including feasibility and appropriateness and methods supporting implementation.
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School-staff mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis
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RUBIES Redesign
Two separate demonstration studies comprising 6 staff members each will focus on informing final RUBIES adaptation or pruning needs.
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School-staff mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of Intervention Measure (AIM): 5-point scale
Time Frame: Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
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The 4-item AIM assesses participants' acceptability of RUBI(ES).
Raters score items on a 5-point scale ranging from (1) "Completely Disagree" to (5) "Completely Agree".
Internal consistency (α = .89)
and test-retest reliability were good (α = .83).
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Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
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Acceptability of Intervention Measure (AIM): 5-point scale
Time Frame: Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
|
The 4-item AIM assesses participants' acceptability of RUBI(ES).
Raters score items on a 5-point scale ranging from (1) "Completely Disagree" to (5) "Completely Agree".
Internal consistency (α = .89)
and test-retest reliability were good (α = .83).
|
Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
|
Intervention Appropriateness Measure (IAM): 5-point scale
Time Frame: Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
|
The 4-item IAM assesses the appropriateness of RUBI(ES).
Raters score each item on a 5-point scale ranging from (1) "Completely Disagree" to (5) "Completely Agree".
Internal consistency (α = .87)
and test-retest reliability were good (α = .87).
|
Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
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Intervention Appropriateness Measure (IAM): 5-point scale
Time Frame: Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
|
The 4-item IAM assesses the appropriateness of RUBI(ES).
Raters score each item on a 5-point scale ranging from (1) "Completely Disagree" to (5) "Completely Agree".
Internal consistency (α = .87)
and test-retest reliability were good (α = .87).
|
Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
|
Feasibility of Intervention Measure (FIM): 5-point scale
Time Frame: Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
|
The 4-item FIM assesses the feasibility of RUBI(ES).
Raters score each item on a 5-point scale ranging from (1) "Completely Disagree" to (5) "Completely Agree".
Internal consistency (α = .89)
and test-retest reliability were good (α = .88).
|
Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
|
Feasibility of Intervention Measure (FIM): 5-point scale
Time Frame: Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
|
The 4-item FIM assesses the feasibility of RUBI(ES).
Raters score each item on a 5-point scale ranging from (1) "Completely Disagree" to (5) "Completely Agree".
Internal consistency (α = .89)
and test-retest reliability were good (α = .88).
|
Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention Usability Scale (IUS)
Time Frame: Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
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The 10-item IUS is adapted from the System Usability Scale and assesses intervention usability on a 5-point scale ranging from (1) "Strongly Disagree" to (5) "Strongly Agree."
A score ≥70 on the IUS demonstrates "good" or better usability.
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Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
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Intervention Usability Scale (IUS)
Time Frame: Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
|
The 10-item IUS is adapted from the System Usability Scale and assesses intervention usability on a 5-point scale ranging from (1) "Strongly Disagree" to (5) "Strongly Agree."
A score ≥70 on the IUS demonstrates "good" or better usability.
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Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Teacher Demographics
Time Frame: Completed by participants at the in-class behavior observation, 4-hour RUBI Redesign meeting, 2 hour RUBIES Collaborative design meeting, or 4 hour RUBIES Redesign meeting
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Measures individual characteristics (age, sex, gender identity, race/ethnicity, years' experience, etc.).
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Completed by participants at the in-class behavior observation, 4-hour RUBI Redesign meeting, 2 hour RUBIES Collaborative design meeting, or 4 hour RUBIES Redesign meeting
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School Demographics
Time Frame: Collected over the course of the 12 month study through public record review of schools where participants are employed
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School Demographics (free/reduced price lunch rate, school size, number of students with disabilities, resources, services, etc.) will be collected through the Office of the Superintendent of Public Instruction and school records.
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Collected over the course of the 12 month study through public record review of schools where participants are employed
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen Bearss, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCH-STUDY00001890
- 1P50MH115837 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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