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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RUBI-A — BEHAVIORAL
    The 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 — BEHAVIORAL
    R-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-A
    Recently redesigned version of the RUBI program for autistic adults and their caregivers
  • Active Comparator: R-ISLEA
    Psychoeducation 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

Locations (3)

FacilityCityStateZIPSite coordinators
Els for Autism FoundationJupiterFlorida33458
Erin Lozott, BCBA-D
Jose Martinez, PhD, BCBA-D
A.J. Drexel Autism InstitutePhiladelphiaPennsylvania19104
Matthew Lerner, PhD
Elizabeth Sheridan, PhD
Seattle Children's Autism CenterSeattleWashington98115
Daina M Tagavi, PhD
206-987-0216
Catherine Dick, PhD

Find similar trials in Jupiter, FL

By specialty

Related Studies