Autism Spectrum DisorderRUBIESNCT05093686
RUBIES in Educational Settings
A study testing RUBIES in people with Autism Spectrum Disorder and Disruptive Behavior, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
The proposed three-year pilot randomized trial aims to test the effectiveness of the newly-redesigned paraeducator-delivered RUBI for use in Educational Settings (RUBIES) intervention compared to usual care training in reducing disruptive behavior in 80 elementary-school children with ASD. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Disruptive Behavior
- What is being tested?
- RUBIES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2021to 31 Jul 2024
- Phase
- Interventional
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Paraeducators must be employed by the school district and work directly with children with ASD in the classroom at their school.
- Students with ASD will be included if they: 1) have a documented ASD diagnosis and a Social Responsiveness Scale-2 total raw score > 70 for males and 65 for females; 2) are enrolled in a Kindergarten-5th grade general or special education classroom and participate in a general education classroom for a minimum of 4 hours/week; 3) have a participating paraeducator; 4) have a teacher-rated Aberrant Behavior Checklist-Irritability (ABC-I) subscale score >15,; and 5) have a stable educational plan and placement.
Who cannot join
- Paraeducator is not supporting a student with autism in a general education classroom
- Student does not have a diagnosis of ASD or elevated disruptive behavior problems
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Research Institute
Seattle, Washington, 98105
Karen Bearss, PhD, 206-987-2880, karen.bearss@seattlechildrens.org
About this study
Official title: Exploring Mechanisms of Change in a Pilot Trial of the RUBI Program in Educational Settings
The proposed three-year pilot randomized trial aims to test the effectiveness of the newly-redesigned paraeducator-delivered RUBI for use in Educational Settings (RUBIES) intervention compared to usual care training in reducing disruptive behavior in 80 elementary-school children with ASD. Given the critical need to understand not just whether, but also how interventions work, this study also will examine paraeducator- and child-level mechanistic pathways of the RUBIES intervention.
Read the detailed description
Autism spectrum disorder (ASD) is a pervasive developmental disorder characterized by deficits in social communication and the presence of restricted and/or repetitive behavior, with prevalence estimates as high as 1 in 54 children in the US. Approximately 50% of children with ASD exhibit disruptive behaviors, such as tantrums, aggression, and noncompliance, a rate that is higher than neurotypical peers in the school environment. Disruptive behaviors impact meaningful engagement in academic tasks and with peers, as well as result in placement in more restrictive settings, higher use of restraint procedures, and suspension, all of which have lasting negative impacts. School-based behavioral management approaches, while effective, are time-consuming and resource-intensive, resulting in high costs and delays in intervention deployment. There is a need for a paradigm shift in the care model for disruptive behaviors in the classroom, specifically an efficient and pragmatic intervention model that builds capacity with direct care providers, which in turn streamlines the intervention process, reduces the need for intensive behavioral supports (thus lowering costs), and increases the number of children with ASD who can be served.
Over the past decade, the Research Units in Behavioral Interventions (RUBI) Autism Network developed and systematically tested a low-intensity (11-session) manualized intervention for parents of children ages 3 to 14 with ASD and co-occurring disruptive behavior. Results across three large scale trials have demonstrated that RUBI significantly reduces child disruptive behavior, and treatment recipients are highly engaged in the intervention. To date, no studies have evaluated the effectiveness of RUBI in schools, the most accessed service system for children with ASD.
With NIMH funding from the University of Washington ALACRITY Center grant (P50MH115837), RUBI content was iteratively redesigned in collaboration with elementary school stakeholders (administrators, teachers, paraeducators) for use in educational settings using the novel Discover, Design, Build, and Test Framework, which combines human-centered design and implementation science. In addition, target end-users (paraeducators) were identified as they: 1) provide direct support to children with ASD in both general and special education classrooms for the majority of the school day; and 2) often do not receive specialized training on effective behavioral management strategies designed to support the unique needs of children with ASD. The proposed three-year pilot randomized trial extends our work to test the effectiveness of the newly-redesigned RUBI for use in Educational Settings (RUBIES) intervention compared to usual care training (UCT) in reducing disruptive behavior in 80 elementary-school children with ASD. Given the critical need to understand not just whether, but also how interventions work, this study also will examine paraeducator- and child-level mechanistic pathways of the RUBIES intervention. Study aims include:
Aim 1: Examine the acceptability and feasibility of RUBIES with paraeducators supporting children with ASD and disruptive behavior in schools. We will measure RUBIES' acceptability (attendance, attrition, satisfaction) and feasibility (demonstration of successful study design) to determine whether paraeducators can successfully implement the RUBIES intervention in schools.
Aim 2: Conduct exploratory analyses of the impact of RUBIES compared to Usual Care Training (UCT) on disruptive behavior. Results will allow us to estimate the means, standard deviations and intraclass correlations of RUBIES compared to UCT on disruptive behavior outcomes, which will be essential for sample size/power calculations for a future definitive longitudinal RCT. Exploratory Hypothesis 1: At Week 24, children whose paraeducator was randomized to RUBIES will exhibit lower rates of observed and reported disruptive behavior compared to children whose paraeducator received UCT.
Aim 3: Conduct exploratory analyses on RUBIES' proposed paraeducator- and child-level mechanisms of change on child disruptive behavior. Exploratory Hypothesis 2: RUBIES will improve paraeducator-level mechanisms (gains in knowledge; use of more effective strategies) which will improve child disruptive behavior compared to UCT. Exploratory Hypothesis 3: RUBIES will improve child-level mechanisms (functional communication skills) which will improve child disruptive behavior compared to UCT.
Specifically, a three-year pilot effectiveness randomized controlled trial will be conducted with 80 paraeducators who support a child with ASD (n=80) from 40 public elementary schools. The child's primary teacher (N=80) and caregiver (N=80) also will be consented to contribute to outcome data on the child's behavior. Thus, 80 "triads" made up of a child-paraeducator-teacher will be enrolled. Data will be collected at baseline, Weeks 8, 12 and 24. Schools will be recruited in three cohorts that align with the school year (Years 1 and 2: N=15 schools, 30 paraeducators, 30 children with ASD, and 30 teachers; Year 3: N=10 schools, 20 paraeducators, 20 children with ASD, and 20 teachers).
Successful completion of the proposed study will allow for a large-scale effectiveness trial of RUBIES in public schools, which has the potential to improve the quality of life for children with ASD across the country.
- Conditions
- Autism Spectrum Disorder, Disruptive Behavior
- Being tested
- RUBIES, Usual Care Training
- Keywords
- autism, elementary schools, paraeducators, disruptive behavior
- Medical subject headings
- Autism Spectrum Disorder, Problem Behavior, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUBIESBehavioural
Also called RUBI in Educational Settings
RUBIES is an 8 module intervention that begins with foundational education on ASD (Session1), followed by introducing basic applied behavior analysis principles (Session 2). Instruction is then provided on strategies that can prevent problematic behaviors from occurring (Session 3 and 4). Reinforcement (Session 5) reviews the use of tangible and social reinforcers tools to promote new/desired behaviors while planned ignoring and functional communication training (Session 6) teaches that disruptive behavior can serve as a form of communication while ignoring disruptive communicative attempts. Sessions conclude with instruction on effective ways to deliver commands to promote compliance (Session 7) and targeting approaches to ensure positive behavior gains can maintain over time and strategies can be used across classrooms and staff (Session 8).
Usual Care TrainingBehavioural
Usual Care Training is an 8 module psychoeducation program that will provide foundational information on autism spectrum disorders, including the diagnostic criteria, appropriate educational services, common interventions, and how to promote social skills in the classroom.
| Study group | Role | What they receive |
|---|---|---|
| RUBIES | Experimental | RUBIES provides paraeducators in training on behavioral strategies based on principles of applied behavior analysis to target student disruptive behaviors in the classroom Receives: Behavioral: RUBIES |
| Usual Care Treatment | Active comparator | Usual Care Treatment provides paraeducators with foundational psychoeducation on autism spectrum disorders. Receives: Behavioral: Usual Care Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist
After 24 weeks of treatment, students whose paraeducator received RUBIES will show greater reduction in classroom disruptive behavior as evidenced by reduction on the Aberrant Behavior Checklist Irritability Subscale compared to students whose paraeducator received Usual Care Treatment.
Measured: 24 Weeks
Secondary outcomes (3)
Knowledge of Behavioral Principles
After 24 weeks of treatment, students whose paraeducator received RUBIES will show greater knowledge in behavioral principles as evidenced by higher scores on the Knowledge of Behavioral Principles measure compared to students whose paraeducator received Usual Care Treatment.
Measured: 24Weeks
RUBIES fidelity
After 24 weeks of treatment, paraeducators who received training in RUBIES will demonstrate observed higher implementation of evidence-based strategies based on applied behavior analysis compared to students whose paraeducator received Usual Care Treatment.
Measured: 24 Weeks
Student Behavior Observation
After 24 weeks of treatment, students whose paraeducator received RUBIES will demonstrate lower observed rates of disruptive behavior in the classroom compared to students whose paraeducator received Usual Care Treatment.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start26 Oct 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Simple 1:1 random assignment will be used to assign half (n=40) of the paraeducator/teacher/child triads to remote training in RUBIES, allowing for personalized delivery and tailoring of RUBIES to the paraeducator-child dyad, and the other half (n=40 dyads) to Usual Care Training (UCT, an "Autism 101" attention control condition) over a three-year period. No greater than 10% paraeducator turnover each year is expected based on prior studies.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Bearss, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093686
- Sponsor's protocol ID
- SCH-STUDY00003191
- Acronym
- RUBIES
- Status last verified
- May 2023
- First submitted
- 3 Oct 2021
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bearss K, Shih W, Tagavi DM, Kuo Y, Fettig A, Locke J. A Pilot Feasibility Randomized Trial of the RUBI in Educational Settings Intervention With Paraeducators Supporting Autistic Students in Public Elementary Schools. J Autism Dev Disord. 2025 Oct 15:10.1007/s10803-025-07072-8. doi: 10.1007/s10803-025-07072-8. Online ahead of print.
PubMed 41091357
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Mechanisms of Change in a Pilot Trial of the RUBI Program in Educational Settings
- ClinicalTrials.gov ID
- NCT05093686
- Acronym / sponsor ID
- RUBIES / SCH-STUDY00003191
- Conditions
- Autism Spectrum Disorder, Disruptive Behavior
- Keywords
- autism, elementary schools, paraeducators, disruptive behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 26 Oct 2021 (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.
The proposed three-year pilot randomized trial aims to test the effectiveness of the newly-redesigned paraeducator-delivered RUBI for use in Educational Settings (RUBIES) intervention compared to usual care training in reducing disruptive behavior in 80 elementary-school children with ASD. Given the critical need to understand not just whether, but also how interventions work, this study also will examine paraeducator- and child-level mechanistic pathways of the RUBIES intervention.
Detailed description
Autism spectrum disorder (ASD) is a pervasive developmental disorder characterized by deficits in social communication and the presence of restricted and/or repetitive behavior, with prevalence estimates as high as 1 in 54 children in the US. Approximately 50% of children with ASD exhibit disruptive behaviors, such as tantrums, aggression, and noncompliance, a rate that is higher than neurotypical peers in the school environment. Disruptive behaviors impact meaningful engagement in academic tasks and with peers, as well as result in placement in more restrictive settings, higher use of restraint procedures, and suspension, all of which have lasting negative impacts. School-based behavioral management approaches, while effective, are time-consuming and resource-intensive, resulting in high costs and delays in intervention deployment. There is a need for a paradigm shift in the care model for disruptive behaviors in the classroom, specifically an efficient and pragmatic intervention model that builds capacity with direct care providers, which in turn streamlines the intervention process, reduces the need for intensive behavioral supports (thus lowering costs), and increases the number of children with ASD who can be served.
Over the past decade, the Research Units in Behavioral Interventions (RUBI) Autism Network developed and systematically tested a low-intensity (11-session) manualized intervention for parents of children ages 3 to 14 with ASD and co-occurring disruptive behavior. Results across three large scale trials have demonstrated that RUBI significantly reduces child disruptive behavior, and treatment recipients are highly engaged in the intervention. To date, no studies have evaluated the effectiveness of RUBI in schools, the most accessed service system for children with ASD.
With NIMH funding from the University of Washington ALACRITY Center grant (P50MH115837), RUBI content was iteratively redesigned in collaboration with elementary school stakeholders (administrators, teachers, paraeducators) for use in educational settings using the novel Discover, Design, Build, and Test Framework, which combines human-centered design and implementation science. In addition, target end-users (paraeducators) were identified as they: 1) provide direct support to children with ASD in both general and special education classrooms for the majority of the school day; and 2) often do not receive specialized training on effective behavioral management strategies designed to support the unique needs of children with ASD. The proposed three-year pilot randomized trial extends our work to test the effectiveness of the newly-redesigned RUBI for use in Educational Settings (RUBIES) intervention compared to usual care training (UCT) in reducing disruptive behavior in 80 elementary-school children with ASD. Given the critical need to understand not just whether, but also how interventions work, this study also will examine paraeducator- and child-level mechanistic pathways of the RUBIES intervention. Study aims include:
Aim 1: Examine the acceptability and feasibility of RUBIES with paraeducators supporting children with ASD and disruptive behavior in schools. We will measure RUBIES' acceptability (attendance, attrition, satisfaction) and feasibility (demonstration of successful study design) to determine whether paraeducators can successfully implement the RUBIES intervention in schools.
Aim 2: Conduct exploratory analyses of the impact of RUBIES compared to Usual Care Training (UCT) on disruptive behavior. Results will allow us to estimate the means, standard deviations and intraclass correlations of RUBIES compared to UCT on disruptive behavior outcomes, which will be essential for sample size/power calculations for a future definitive longitudinal RCT. Exploratory Hypothesis 1: At Week 24, children whose paraeducator was randomized to RUBIES will exhibit lower rates of observed and reported disruptive behavior compared to children whose paraeducator received UCT.
Aim 3: Conduct exploratory analyses on RUBIES' proposed paraeducator- and child-level mechanisms of change on child disruptive behavior. Exploratory Hypothesis 2: RUBIES will improve paraeducator-level mechanisms (gains in knowledge; use of more effective strategies) which will improve child disruptive behavior compared to UCT. Exploratory Hypothesis 3: RUBIES will improve child-level mechanisms (functional communication skills) which will improve child disruptive behavior compared to UCT.
Specifically, a three-year pilot effectiveness randomized controlled trial will be conducted with 80 paraeducators who support a child with ASD (n=80) from 40 public elementary schools. The child's primary teacher (N=80) and caregiver (N=80) also will be consented to contribute to outcome data on the child's behavior. Thus, 80 "triads" made up of a child-paraeducator-teacher will be enrolled. Data will be collected at baseline, Weeks 8, 12 and 24. Schools will be recruited in three cohorts that align with the school year (Years 1 and 2: N=15 schools, 30 paraeducators, 30 children with ASD, and 30 teachers; Year 3: N=10 schools, 20 paraeducators, 20 children with ASD, and 20 teachers).
Successful completion of the proposed study will allow for a large-scale effectiveness trial of RUBIES in public schools, which has the potential to improve the quality of life for children with ASD across the country.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Simple 1:1 random assignment will be used to assign half (n=40) of the paraeducator/teacher/child triads to remote training in RUBIES, allowing for personalized delivery and tailoring of RUBIES to the paraeducator-child dyad, and the other half (n=40 dyads) to Usual Care Training (UCT, an "Autism 101" attention control condition) over a three-year period. No greater than 10% paraeducator turnover each year is expected based on prior studies.
| Arm | Type | Receives |
|---|---|---|
| RUBIES | Experimental | Behavioral: RUBIESRUBIES provides paraeducators in training on behavioral strategies based on principles of applied behavior analysis to target student disruptive behaviors in the classroom |
| Usual Care Treatment | Active comparator | Behavioral: Usual Care TrainingUsual Care Treatment provides paraeducators with foundational psychoeducation on autism spectrum disorders. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Paraeducators must be employed by the school district and work directly with children with ASD in the classroom at their school.
- Students with ASD will be included if they: 1) have a documented ASD diagnosis and a Social Responsiveness Scale-2 total raw score > 70 for males and 65 for females; 2) are enrolled in a Kindergarten-5th grade general or special education classroom and participate in a general education classroom for a minimum of 4 hours/week; 3) have a participating paraeducator; 4) have a teacher-rated Aberrant Behavior Checklist-Irritability (ABC-I) subscale score >15,; and 5) have a stable educational plan and placement.
Key exclusion criteria (2 listed)
- Paraeducator is not supporting a student with autism in a general education classroom
- Student does not have a diagnosis of ASD or elevated disruptive behavior problems
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 |
|---|---|---|
| RUBIESAlso: RUBI in Educational SettingsRUBIES is an 8 module intervention that begins with foundational education on ASD (Session1), followed by introducing basic applied behavior analysis principles (Session 2). Instruction is then provided on strategies that can prevent problematic behaviors from occurring (Session 3 and 4). Reinforcement (Session 5) reviews the use of tangible and social reinforcers tools to promote new/desired behaviors while planned ignoring and functional communication training (Session 6) teaches that disruptive behavior can serve as a form of communication while ignoring disruptive communicative attempts. Sessions conclude with instruction on effective ways to deliver commands to promote compliance (Session 7) and targeting approaches to ensure positive behavior gains can maintain over time and strategies can be used across classrooms and staff (Session 8). | Behavioural | RUBIES |
| Usual Care TrainingUsual Care Training is an 8 module psychoeducation program that will provide foundational information on autism spectrum disorders, including the diagnostic criteria, appropriate educational services, common interventions, and how to promote social skills in the classroom. | Behavioural | Usual Care Treatment |
Primary outcome
Aberrant Behavior Checklist
Time frame: 24 Weeks
After 24 weeks of treatment, students whose paraeducator received RUBIES will show greater reduction in classroom disruptive behavior as evidenced by reduction on the Aberrant Behavior Checklist Irritability Subscale compared to students whose paraeducator received Usual Care Treatment.
3 secondary outcomes
Knowledge of Behavioral Principles
Time frame: 24Weeks
RUBIES fidelity
Time frame: 24 Weeks
Student Behavior Observation
Time frame: 24 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Derived from this study: PubMed 41091357Bearss K, Shih W, Tagavi DM, Kuo Y, Fettig A, Locke J. A Pilot Feasibility Randomized Trial of the RUBI in Educational Settings Intervention With Paraeducators Supporting Autistic Students in Public Elementary Schools. J Autism Dev Disord. 2025 Oct 15:10.1007/s10803-025-07072-8. doi: 10.1007/s10803-025-07072-8. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RUBIES in people with Autism Spectrum Disorder and Disruptive Behavior, run by Seattle Children's Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 8 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Bearss, PhD (206-987-2880, karen.bearss@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05093686, which also lists 1 linked publication.
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 8 May 2023.