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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04199533
• Other study ID #: SCH-STUDY00001890
• Secondary ID: 1P50MH115837
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Disruptive Behavior
• Problem Behavior

Intervention

Behavioral:
• RUBI
Parent-mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis
• RUBIES
School-staff mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis

Locations

Country	Name	City	State
United States	Seattle Public Schools	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Teacher Demographics	Measures individual characteristics (age, sex, gender identity, race/ethnicity, years' experience, etc.).	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
Other	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.	Collected over the course of the 12 month study through public record review of schools where participants are employed
Primary	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 (a = .89) and test-retest reliability were good (a = .83).	Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
Primary	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 (a = .89) and test-retest reliability were good (a = .83).	Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
Primary	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 (a = .87) and test-retest reliability were good (a = .87).	Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
Primary	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 (a = .87) and test-retest reliability were good (a = .87).	Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
Primary	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 (a = .89) and test-retest reliability were good (a = .88).	Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
Primary	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 (a = .89) and test-retest reliability were good (a = .88).	Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
Secondary	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.	Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
Secondary	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.	Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)