Evaluating the RUBI Program for Autistic Adults

Pilot Randomized Trial of the RUBI Program for Families of Autistic Adults

This study is testing a new program called RUBI to see if it can help autistic adults manage challenging behaviors and improve their quality of life compared to another program.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Seattle Children's Hospital (other)
• Locations: 3 sites (Jupiter, Florida and 2 other locations)
• Trial ID: NCT06593613 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of a redesigned RUBI parenting intervention for autistic adults experiencing challenging behaviors. Participants will either receive the RUBI intervention or an active control program called ISLEA, with a focus on enhancing communication, co-regulation, and autonomy. The study will evaluate the feasibility and acceptability of the RUBI program, as well as its impact on reducing challenging behaviors and improving the quality of life for autistic adults and their families.

Who should consider this trial

Good fit: Ideal candidates for this study are autistic adults aged 18 and older who live at home with their parents and exhibit mild to moderate challenging behaviors.

Not a fit: Patients who are not living at home with a parent or who do not exhibit challenging behaviors may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the quality of life and adaptive skills for autistic adults and their families.

How similar studies have performed: Previous studies have shown the RUBI intervention to be effective for children, but this adaptation for adults is a novel approach.

Eligibility criteria

Inclusion Criteria:

* Autistic adults will:

  1. be age ≥ 18 years;
  2. live at home with their parent and be able to attend each session;
  3. have a community diagnosis of autism (confirmed through record documentation) and Social Communication Questionnaire (SCQ) total score \> 15;
  4. have a parent rated 24-item EDI Reactivity Score \> 50 percentile, which reflects mild to moderate challenging behaviors (e.g., outbursts; verbal aggression);
  5. have receptive language \> 18 months as measured on the Mullen Scales of Early Learning (MSEL) Receptive Language subtest or similar measure of receptive language;
  6. have a stable educational/vocational plan and be medication free or on stable medication (no changes in prior 6 weeks or planned changes for 16 weeks). Individuals on stable medication will be included as this enhances sample representativeness.
* Parents/Legally Authorized Representatives will be able to:

  1. attend each session.

Exclusion Criteria:

* Autistic adults with: (1) serious medical conditions requiring immediate care (e.g., uncontrolled seizures) or (2) serious behavioral challenges where safety to self and/or others is of concern and that warrant more immediate or intensive treatment (e.g., self-injurious behaviors or aggression resulting in tissue damage). This will be evaluated through case panel with study site Principal Investigators.
* Parents/Legally Authorized Representatives where they are unable to attend weekly virtual or in person sessions over the course of 20 weeks.

Where this trial is running

Jupiter, Florida and 2 other locations

• Els for Autism Foundation — Jupiter, Florida, United States (NOT_YET_RECRUITING)
• A.J. Drexel Autism Institute — Philadelphia, Pennsylvania, United States (NOT_YET_RECRUITING)
• Seattle Children's Autism Center — Seattle, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Daina M Tagavi, PhD — Seattle Children's Hospital
• Study coordinator: Daina M Tagavi, PhD

Conditions: Autism Spectrum Disorder, Behavior, Parenting