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Completed

NCT Number: NCT04199533

Iterative Redesign of a Behavioral Skills Training Program for Use in Educational Settings

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.

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Key information

Conditions

Autism Spectrum Disorder Behavior Behavioral Symptoms Child Behavior Child Development Disorders, Pervasive Disruptive Behavior Mental Disorders Neurodevelopmental Disorders Problem Behavior

Sex eligibility

All sexes

Study type

Observational

Primary location

Seattle Public Schools

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

RUBI

Behavioral

Parent-mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis

RUBIES

Behavioral

School-staff mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis

Primary outcomes

  1. Acceptability of Intervention Measure (AIM): 5-point scale

    Time frame: Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)

    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).

  2. 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).

  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).

  4. 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).

  5. 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).

  6. 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).

Secondary outcomes

  1. Intervention Usability Scale (IUS)

    Time frame: Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)

    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.

  2. 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.

Other outcomes

  1. 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

    Measures individual characteristics (age, sex, gender identity, race/ethnicity, years' experience, etc.).

  2. School Demographics

    Time frame: Collected over the course of the 12 month study through public record review of schools where participants are employed

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2019
Registry last updated
May 20, 2022

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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