Pilot Trial of the RUBI Program for Autistic Adults
This study is testing a redesigned program called RUBI-A to help autistic adults who experience challenging behaviors. Researchers want to see if RUBI-A can reduce these behaviors and improve daily living skills. You would be comparing RUBI-A to another program called R-ISLEA, which teaches about autism but doesn't focus on specific behavior strategies. The study will measure changes in emotions, challenging behaviors, and overall behavior using questionnaires filled out by caregivers and the autistic adults themselves. This trial is for autistic adults aged 18 and older who live at home with a parent and have a confirmed autism diagnosis. The goal is to find out if RUBI-A is practical, acceptable, and effective in improving the quality of life for autistic adults and their families.
- Study design
- This is an interventional study comparing two different behavioral programs, RUBI-A and R-ISLEA. It plans to enroll 80 participants.
- What's involved
- Participants will attend sessions and complete questionnaires at the start, at 8 weeks, 16 weeks, and 20 weeks into the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 20 weeks, with assessments at baseline, week 8, week 16, and week 20.
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Pilot Trial of the RUBI Program for Autistic Adults
At a glance
Conditions
NCT06593613
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
A.J. Drexel Autism Institute
Philadelphia, Pennsylvaniastudy coordinator listed
Not yet recruiting
Seattle Children's Autism Center
Seattle, Washingtonstudy coordinator listed
Recruiting
Els for Autism Foundation
Jupiter, Floridano site contact published
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Daina M Tagavi, PhD · PRINCIPAL_INVESTIGATOR · Seattle Children's Hospital
Who to contact
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What this trial measures
- Emotion Dysregulation Inventory (EDI)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.
The EDI is an informant report measure of emotion dysregulation over the past 7 days, rated on a five-point scale from "not at all" to "very severe." The EDI produces scores for Reactivity and Dysphoria. Cronbach's alpha ranges from .90-.97.
- Open Source Challenging Behavior Scale (OS-CBS)We will administer the OS-CBS to the caregiver at Baseline, Week 8, Week 16, and Week 20.
The OS-CBS is an 18-item questionnaire that asks caregivers to rate, over the past month, how much of a problem a specific behavior is, using a 5-point Likert Scale (1 = Not at all a problem, 2 = Mild Problem, 3 = Moderate Problem, 4 = Severe Problem, 5 = Very Severe Problem).
- Aberrant Behavior Checklist (ABC)We will administer the ABC to the caregiver at Baseline and Week 20.
The ABC measures behavioral challenges in individuals with developmental disabilities. It contains 58 items, with 5 subscales: Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactivity/Noncompliance, and Inappropriate Speech. Items are scored from 0 (never a problem) to 3 (severe problem). Higher scores indicate greater problems in that area. The ABC has high subscale internal consistency (mean alpha = 0.91), excellent test-retest reliability (mean r = 0.98), acceptable inter-rater reliability (mean r = 0.63). The ABC has been used in previous RUBI trials and is sensitive to change with intervention.
- Home Situations Questionnaire - Autism Spectrum Disorder (HSQ-ASD)We will administer the HSQ-ASD to the caregiver at Baseline, Week 8, Week 16, and Week 20.
The HSQ-ASD is a 24-item parent-rated measure of challenging daily routines for autistic individuals. The scale yields per-item mean scores of 0 to 9 (higher scores = greater situational challenges). Based on prior studies, a 25% decrease reflects meaningful improvement in behaviors during daily routine activities.
- Top Problems Assessment (TPA)We will administer the TPA to the caregiver and autistic adult at Baseline and weekly through Week 20.
The TPA entails gathering severity ratings (scale of 0-4) of the top three problems the autistic adult and parent independently identify as most important to them. Psychometric analyses of the TPA have showed substantial evidence of test-retest reliability (.69-.91), convergent and discriminant validity, and sensitivity to clinical change with treatment.