Pilot Trial of the RUBI Program for Autistic Adults
Launched by SEATTLE CHILDREN'S HOSPITAL · Sep 9, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a program called RUBI, which is designed to help autistic adults who experience challenging behaviors. The main goal is to see if this new version of the RUBI program can help reduce these behaviors and improve daily living skills for participants. The trial will compare the RUBI program with another program called ISLEA, which focuses on understanding autism. Researchers want to find out if the RUBI program is both practical and beneficial for autistic adults and their families.
To be eligible for the trial, participants must be at least 18 years old, live at home with a parent, and have a confirmed diagnosis of autism. They should also have mild to moderate challenging behaviors, as rated by their parents, and be able to attend sessions consistently. Throughout the 20-week trial, participants will join sessions to learn skills that promote better communication and independence. They will also complete assessments to track their progress in areas like behavior and quality of life. This trial is currently recruiting participants, and it’s a great opportunity for those looking for support in managing behaviors associated with autism.
Gender
ALL
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.
About Seattle Children's Hospital
Seattle Children's Hospital is a leading pediatric healthcare institution dedicated to advancing the health and well-being of children through innovative clinical research and trials. As a prominent sponsor of clinical studies, the hospital focuses on developing new treatments and therapies that address the unique medical needs of children. With a commitment to excellence, Seattle Children's Hospital collaborates with a network of researchers, healthcare professionals, and academic institutions to ensure rigorous scientific standards and ethical practices in all its clinical investigations. By prioritizing patient safety and scientific integrity, the hospital aims to contribute to the global body of knowledge in pediatric medicine and improve outcomes for children with various health conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jupiter, Florida, United States
Philadelphia, Pennsylvania, United States
Seattle, Washington, United States
Patients applied
Trial Officials
Daina M Tagavi, PhD
Principal Investigator
Seattle Children's Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported