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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: RUBI-AExperimental treatment 1 intervention
Group B: R-ISLEAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Emotion Dysregulation Inventory (EDI)
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.
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 20.2
Open Source Challenging Behavior Scale (OS-CBS)
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).
Time frame
We will administer the OS-CBS to the caregiver at Baseline, Week 8, Week 16, and Week 20.3
Aberrant Behavior Checklist (ABC)
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.
Time frame
We will administer the ABC to the caregiver at Baseline and Week 20.4
Home Situations Questionnaire - Autism Spectrum Disorder (HSQ-ASD)
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.
Time frame
We will administer the HSQ-ASD to the caregiver at Baseline, Week 8, Week 16, and Week 20.Secondary outcomes
1
Adaptive Behavior Assessment System - Third Edition (ABAS-3)
The ABAS-3 is a norm-referenced measure that assesses adaptive behavior and related skills for individuals from birth through 89 years. Information may be provided by parents or the individual themselves. Scores help describe a person's general adaptive behavior, as well as functioning in 11 related skill areas: Communication, Community Use, Functional Academics, School/Home Living, Health and Safety, Leisure, Self-Care, Self-Direction, Social, Work (for older adolescents and adults), and Motor.
Time frame
We will administer the ABAS-3 to the caregiver at Baseline and Week 20.2
World Health Organization QOL Assessment-Brief (WHO-QOL-BRIEF)
The WHO-QOL-BRIEF is a 26-item self-report QoL measure using a 5-point scale, with higher scores indicating better QoL. Questions assess QoL in the domains of physical/psychological health, social relationships, and environment. The WHO-QOL is sensitive to intervention change and has strong internal consistency (α = 0.71-0.82) with autistic adults, who have been shown to accurately report their own QoL (ratings comparable to parents). We will be utilizing both the WHO-QOL-BRIEF, which includes the Disabilities Supplement and Autism Spectrum QoL Supplement.
Time frame
We will administer the WHO-QOL-BRIEF to the autistic adult at Baseline and Week 20.3
RUBI Knowledge Assessment and ISLEA Proximal Knowledge Measure
The RUBI Knowledge Assessment and ISLEA Proximal Knowledge Measure were designed by study team members to evaluate intervention-specific knowledge gained from pre to post treatment.
Time frame
We will administer the knowledge questionnaire to the caregiver and autistic adult at Baseline and Week 16.4
Autism-Specific Parenting Self-Efficacy Scale
The Autism-Specific Parenting Self-Efficacy Scale is a 17-item measure of parents' confidence in their ability to manage the unique parenting challenges of raising an autistic child. (mean alpha = 0.91, indicating a high level of internal consistency across scale items).
Time frame
We will administer the self-efficacy scale to the caregiver at Baseline and Week 16.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Seattle Children's Hospital
Lead sponsor
Els for Autism
Collaborator
Drexel University
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov