Pilot Trial of the RUBI Program for Autistic Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeattle Children's Hospital
About 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.
Eligibility criteria
Qualifiers
be age ≥ 18 years;
live at home with their parent and be able to attend each session;
have a community diagnosis of autism (confirmed through record documentation) and Social Communication Questionnaire (SCQ) total score > 15;
have a parent rated 24-item EDI Reactivity Score > 50 percentile, which reflects mild to moderate challenging behaviors (e.g., outbursts; verbal aggression);
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RUBI-A
- R-ISLEA
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Seattle Children's Hospital
Lead sponsor
Els for Autism
Collaborator
Drexel University
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov