Pilot Trial of the RUBI Program for Autistic Adults
Part of paid clinical trials in Jupiter, Florida.
- Sponsor
- Seattle Children's Hospital
- Study ID
- NCT06593613
- Status
- Recruiting
Conditions
- Autism Spectrum Disorder
- Behavior
- Parenting
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- RUBI-A — BEHAVIORALThe RUBI-A intervention includes 9 sessions covering Behavioral Principles, Prevention Strategies, Visual Supports, Reinforcement, Co-Regulation, Supporting Communication, Effective Instructions, Teaching Skills, and Generalization and Maintenance. RUBI teaches skills to help build a behavioral "toolbox" for challenging behaviors and adaptive skills. RUBI emphasizes: 1) tailoring the intervention to the specific individual; 2) identifying behavioral function instead of topography to inform behavioral strategy choice; 3) increasing appropriate behaviors; and 4) using positive behavioral supports,39,40 such as antecedent management (e.g., use of visual supports), reinforcement, and functional communication strategies to support independence, self-help, and safety skills.
- R-ISLEA — BEHAVIORALR-ISLEA training focuses on increasing core knowledge and understanding of autism, but it does not provide specific guidance on behavioral strategies for managing challenging behaviors. Developed by autism experts at Drexel University in collaboration with autistic self-advocates, ISLEA is a commercially available psychoeducation program designed for educators, direct support staff, families, caregivers, and autistic individuals. If English is not the language of care for a dyad, subtitles in the preferred language will be provided for the webinars, and interpreters will be available for the live sessions.
Study Details
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.
Key Dates
- Start date
- Sep 1, 2024
- Status verified
- Sep 2024
- Primary completion
- Dec 31, 2024
- Completion
- Dec 31, 2024
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: RUBI-ARecently redesigned version of the RUBI program for autistic adults and their caregivers
- Active Comparator: R-ISLEAPsychoeducation control condition
Primary Outcome Measure
Emotion Dysregulation Inventory (EDI) [ Time Frame: We will use the 24-item Caregiver Reactivity scale for screening, the full 30-item Caregiver form at Baseline, Week 8, Week 16, and Week 20, and the 13-item Self-Report scale at Baseline, Week 8, Week 16, and Week 20. ]
Central Contacts
- Daina M Tagavi, PhD206-987-0216
- Catherine Dick, PhD
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Els for Autism Foundation | Jupiter | Florida | 33458 | Erin Lozott, BCBA-D Jose Martinez, PhD, BCBA-D |
| A.J. Drexel Autism Institute | Philadelphia | Pennsylvania | 19104 | Matthew Lerner, PhD Elizabeth Sheridan, PhD |
| Seattle Children's Autism Center | Seattle | Washington | 98115 | Catherine Dick, PhD |
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