RUBI Program for Autism Spectrum Disorder

(RUBI-A Trial)

Recruiting at 2 trial locations

Overseen By Catherine Dick, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Uncontrolled seizures, Self-injurious behaviors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new version of the RUBI parenting program (RUBI-A) can reduce challenging behaviors and improve life skills for autistic adults living with their parents. Participants will either engage with the redesigned RUBI program or join a control group focused on autism education. The trial seeks to assess whether the RUBI program is more effective in enhancing daily life for autistic adults and their families. It is suitable for autistic adults who live at home, exhibit mild to moderate challenging behaviors such as verbal outbursts, and can attend all sessions with a parent. As an unphased trial, this study provides a unique opportunity to contribute to innovative autism care strategies.

Do I have to stop taking my current medications for the trial?

You don't have to stop taking your current medications, but you need to be on a stable medication plan, meaning no changes in the last 6 weeks and no planned changes for the next 16 weeks.

What prior data suggests that the redesigned RUBI intervention is safe for autistic adults?

Research has shown that the RUBI program is safe. In past studies, researchers used the RUBI program with children and adults on the autism spectrum, demonstrating its effectiveness in addressing challenging behaviors without major side effects. The program teaches skills to parents and caregivers, avoiding medications or medical procedures, making it a low-risk option for participants.

While researchers are updating RUBI for adults, past results from its use with children and families support its safety. The program aims to improve communication and behavior in a supportive way. This evidence suggests that the RUBI program is well-tolerated and safe for autistic adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RUBI-A program because it offers a fresh approach for supporting autistic adults and their caregivers. Unlike traditional treatments that often focus solely on the individual with autism, RUBI-A integrates caregivers into the process, providing them with tools and strategies to better support their loved ones. This redesigned program emphasizes practical, everyday solutions and personalized support, potentially leading to more meaningful improvements in the quality of life for both autistic individuals and their caregivers. By fostering a collaborative environment, RUBI-A hopes to create lasting, positive changes in family dynamics.

What evidence suggests that this trial's treatments could be effective for autism spectrum disorder?

Research has shown that the RUBI Parent Training program effectively reduces challenging behaviors such as irritability and noncompliance in children with autism. Studies have found that this program helps manage disruptive behaviors and is practical and well-received by families. Early results suggest that even shorter versions of the program can have a positive effect. In this trial, participants will receive either the redesigned RUBI-A program for autistic adults and their caregivers or the R-ISLEA psychoeducation control condition. Although the current trial focuses on a redesigned version for adults, the program's proven success in children provides a strong basis for its potential effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Daina M Tagavi, PhD

Principal Investigator

Seattle Children's Hospital

Are You a Good Fit for This Trial?

This trial is for autistic adults with challenging behaviors and their families. Participants will engage in a program to improve communication, co-regulation, and autonomy. They must be willing to attend sessions and complete assessments over a 20-week period.

Inclusion Criteria

Autistic adults with a community diagnosis of autism confirmed through record documentation and SCQ total score > 15

Autistic adults with a parent rated 24-item EDI Reactivity Score > 50 percentile reflecting mild to moderate challenging behaviors

Parents/Legally Authorized Representatives able to attend each session

Exclusion Criteria

Parents/Legally Authorized Representatives unable to attend weekly virtual or in-person sessions over 20 weeks

I am an adult with autism and have serious medical or behavioral needs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the redesigned RUBI intervention or the ISLEA program over a 20-week period

20 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• R-ISLEA
• RUBI-A

Trial Overview The study tests the RUBI parenting intervention against an active control group receiving ISLEA. It aims to see if RUBI can reduce challenging behaviors and enhance quality of life more effectively than ISLEA.

How Is the Trial Designed?

Group I: RUBI-A Experimental Treatment 1 Intervention

Recently redesigned version of the RUBI program for autistic adults and their caregivers

Group II: R-ISLEA Active Control 1 Intervention

Psychoeducation control condition

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

Els for Autism

Collaborator

Trials

1

Recruited

80+

Drexel University

Collaborator

Trials

160

Recruited

48,600+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1750946719300972

RUBI parent training as a group intervention for children ... This study sought to provide preliminary evidence supporting the use of the RUBI Parent Training program as a group intervention.

2. digital.lib.washington.edu digital.lib.washington.edu/researchworks/items/81e4543f-4b1f-4ec8-b8f4-bb4eaf16d872/full

Examining the Efficacy of the RUBI Parent Training Program in ... Results indicate that the RUBI parent training program is efficacious in reducing child disruptive behaviors of irritability and noncompliance ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9055015/

A Preliminary Evaluation of a Brief Behavioral Parent Training ... Challenging behaviors were reduced in the BPT and active control groups. The novel BPT was a feasible and acceptable intervention to target challenging ...

4. researchgate.net researchgate.net/publication/395546547_Effectiveness_of_a_Time-limited_Parent_Training_Program_via_Telehealth_for_Children_With_Autism_Spectrum_Disorder_and_Externalizing_Behavior

Effectiveness of a Time-limited Parent Training Program via ... Method: This study sought to provide preliminary evidence supporting the use of the RUBI Parent Training program as a group intervention. The ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05742464

Training and Implementation of RUBI in Community Mental ... This project is focused on evaluating outcomes related to this statewide clinical training effort in the RUBI parent training program.

6. rubinetwork.org rubinetwork.org/

The RUBI Autism Network RUBI Autism Network is a team of experts in the field of autism spectrum disorder located at five university based medical centers.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9959946/

The RUBI Parent Training for Disruptive Behavior in a ... RUBI-PT was created for use with preschool-aged children with ASD and co-occurring disruptive behaviors such as noncompliance, tantrums, aggression, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04199533

Iterative Redesign of a Behavioral Skills Training Program ... The RUBI program is an evidence-based parent-mediated intervention that improves disruptive behavior in children with ASD. Considering schools serve as the ...

9. jadehealth.org jadehealth.org/learning-hub/rubi-parent-training-program-for-autistic-youth-with-challenging-behaviors/

An Overview of The RUBI Parent Training Program ... RUBI accommodates a wide range of abilities across the autism spectrum, excluding behaviors that pose significant health and safety risks.

10. journals.sagepub.com journals.sagepub.com/doi/10.1177/15346501231170149

An Intervention Program for Families of Adults on the ... In short, findings from this case study provide preliminary promise that RUBI can be delivered to caregivers of adults on the autism spectrum ...