Autism Spectrum DisorderNCT04199533
Iterative Redesign of a Behavioral Skills Training Program for Use in Educational Settings
An observational study of Autism Spectrum Disorder and Disruptive Behavior, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Disruptive Behavior
- What is being tested?
- RUBI and RUBIES
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Elementary school personnel who work with students with autism spectrum disorder
Who may be able to join
- 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
Who cannot join
- -School personnel who do not have contact with youth with ASD during the work day
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Disruptive Behavior
- Being tested
- RUBI, RUBIES
- Medical subject headings
- Autism Spectrum Disorder, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUBIBehavioural
Parent-mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis
RUBIESBehavioural
School-staff mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. Receives: Behavioral: RUBI | |
| 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. Receives: Behavioral: RUBIES | |
| RUBIES Redesign | Two separate demonstration studies comprising 6 staff members each will focus on informing final RUBIES adaptation or pruning needs. Receives: Behavioral: RUBIES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start1 Sep 2019
- Primary completion30 Jun 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Karen Bearss, University of Washington
- Investigators
- Karen Bearss, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199533
- Sponsor's protocol ID
- SCH-STUDY00001890
- Other IDs
- 1P50MH115837
- Status last verified
- May 2022
- First submitted
- 9 Oct 2019
- Last updated
- 20 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iterative Redesign of a Behavioral Skills Training Program for Use in Educational Settings
- ClinicalTrials.gov ID
- NCT04199533
- Acronym / sponsor ID
- SCH-STUDY00001890
- Conditions
- Autism Spectrum Disorder, Disruptive Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
| RUBI Redesign | – | Behavioral: RUBITwo 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. |
| RUBIES Collaborative Design | – | Behavioral: RUBIESEight 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. |
| RUBIES Redesign | – | Behavioral: RUBIESTwo separate demonstration studies comprising 6 staff members each will focus on informing final RUBIES adaptation or pruning needs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Elementary school personnel who work with students with autism spectrum disorder
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -School personnel who do not have contact with youth with ASD during the work day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RUBIParent-mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis | Behavioural | RUBI Redesign |
| RUBIESSchool-staff mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis | Behavioural | RUBIES Collaborative Design, RUBIES Redesign |
Primary outcome
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).
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).
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).
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).
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).
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).
2 secondary outcomes
Intervention Usability Scale (IUS)
Time frame: Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)
Intervention Usability Scale (IUS)
Time frame: Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Bearss, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Disruptive Behavior, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM): 5-point scale (time frame: Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.