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?

The goal of this clinical trial is to evaluate if a redesigned version of the RUBI parenting intervention can reduce challenging behaviors and improve adaptive skills in autistic adults with co-occurring challenging behaviors. The main questions it aims to answer are: * Is the redesigned RUBI intervention feasible and acceptable for autistic adults and their families? * Does the redesigned RUBI intervention reduce challenging behaviors and enhance the quality of life for autistic adults? * Researchers will compare the redesigned RUBI intervention to an active control group, Introduction to the Science and Lived Experience of Autism (ISLEA), to see if RUBI is more effective in improving outcomes for autistic adults and their families. Participants will: * Attend sessions where they receive either the RUBI intervention or the ISLEA program. * Engage in activities designed to promote communication, co-regulation, and autonomy in the context of supporting autistic adults. * Complete assessments at the start, throughout, and at the end of the 20-week trial to evaluate outcomes such as challenging behaviors, adaptive skills, and quality of life.

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+