An observational study in Autism Spectrum Disorder and Disruptive Behavior, sponsored by University of Washington. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-05-20.
Sponsored by University of Washington · Observational
This study proposes to redesign the RUBI Parent Training program, a low-intensity intervention for youth with autism spectrum disorder and disruptive behavior, for use by school personnel in the classroom. Using a mixed-methods approach, 40 school staff members from 20 elementary schools will be recruited to inform current classroom behavior management practices and RUBI redesign needs.
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.
1,755 studies on the registry are indexed under Autism Spectrum Disorder; 507 are open to participants now.
This study's enrollment of 40 is below the median of 102 across 328 observational studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Elementary school personnel who work with students with autism spectrum disorder
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-School personnel who do not have contact with youth with ASD during the work day
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.
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.
Behavioral: RUBI
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.
Behavioral: RUBIES
Two separate demonstration studies comprising 6 staff members each will focus on informing final RUBIES adaptation or pruning needs.
Behavioral: RUBIES
Parent-mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis
School-staff mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis
Acceptability of Intervention Measure (AIM): 5-point scale
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).
Time frame: Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
Acceptability of Intervention Measure (AIM): 5-point scale
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).
Time frame: Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
Intervention Appropriateness Measure (IAM): 5-point scale
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).
Time frame: Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
Intervention Appropriateness Measure (IAM): 5-point scale
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).
Time frame: Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
Feasibility of Intervention Measure (FIM): 5-point scale
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).
Time frame: Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
Feasibility of Intervention Measure (FIM): 5-point scale
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).
Time frame: Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
Intervention Usability Scale (IUS)
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.
Time frame: Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
Intervention Usability Scale (IUS)
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.
Time frame: Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
Teacher Demographics
Measures individual characteristics (age, sex, gender identity, race/ethnicity, years' experience, etc.).
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
School Demographics
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.
Time frame: Collected over the course of the 12 month study through public record review of schools where participants are employed
Ran from Sep 2019 to primary completion in Jun 2021, 21 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.