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.
Over the past decade, across three large-scale, NIH-funded trials, the Research Unit in Behavioral Interventions (RUBI) Autism Network developed and systematically tested a low-intensity manualized parenting intervention for autistic children ages 3-14 with challenging behaviors.8-10 RUBI teaches families how to foster home environments that support their autistic child, including teaching parents how to understand their child's behaviors as forms of communication, respond and adapt to their child's unique needs, and personalize strategies for their child's needs and preferences (e.g. utilizing visual supports to align with information processing needs; attuning to the negative impact of unpredictable expectations; accommodating sensory needs). RUBI also may be a promising approach to support families as they provide care and support to their autistic adult dependents. RUBI has been found to be acceptable to families, reliably delivered by trained therapists, and effective in reducing challenging behaviors and increasing adaptive skills in children.8-10 In response to the shortage of efficacious interventions for autistic adults, RUBI could serve to be systematically redesigned to better support collaboration between family members and their autistic adult dependents, thereby helping autistic adults lead more meaningful and independent lives. To this end, RUBI was recently redesigned utilizing the Discover, Design/Build, Test (DDBT) Framework,11 which leverages user-centered design, participatory action research, and implementation science to ensure that a modified intervention meets the needs of end users (parents, autistic adults, community providers) and is viable across contexts (home, community). Redesign targets included (1) changes in text examples, in-session activities, and language to be more acceptable and relevant to the autistic adult population, (2) content modifications to align focus on supporting communication and dyad co-regulation, (3) improvement in inclusionary and collaborative engagement strategies, and (4) promotion of the autistic adult's engagement, autonomy, and agency during sessions and when implementing strategies. With the Discover, Design/Build phases successfully completed, a two-year pilot randomized trial will extend our work to the Test phase in order to evaluate the feasibility, acceptability, and efficacy of the newly redesigned RUBI intervention compared to an active control - Introduction to the Science and Lived Experience of Autism (ISLEA). Eighty autistic adults with co-occurring challenging behaviors and their parents will be randomized 1:1 to either RUBI or ISLEA and followed for 20 weeks in order to evaluate key outcomes, including feasibility and acceptability of the redesigned RUBI intervention. This study will also explore the impact of RUBI on autistic adults' challenging behaviors, adaptive skills, and quality of life as well as parent self-efficacy. Successful completion of this proposed pilot study will allow for a future large-scale effectiveness trial of RUBI with autistic adults and their parents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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 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.
Els for Autism Foundation
Jupiter, Florida, United States
NOT_YET_RECRUITINGA.J. Drexel Autism Institute
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGSeattle Children's Autism Center
Seattle, Washington, United States
RECRUITINGEmotion 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.
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.
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.
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.
Top Problems Assessment (TPA)
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.
Time frame: We will administer the TPA to the caregiver and autistic adult at Baseline and weekly through Week 20.
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.
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.
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.
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.
Zarit-Burden Questionnaire
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Zarit-Burden Questionnaire is a 22-item measure that reflects how caregivers feel when taking care of another person.
Time frame: We will administer the Zarit-Burden scale to the caregiver at Baseline and Week 16.
Personal Advocacy Activity Scale (PAAS)
The PAAS measures self-reported personal advocacy activities. The PAAS reflects self-reported personal advocacy activities engaged in over the past 3 months. A total of 25 items (e.g., "In the past 3 months, how many times have you arrived organized and prepared for a meeting?") were written using a scale indicating how frequently respondents have engaged in the behavior in the past 3 months (choices were Not at all, 1-2 times, 3- 4 times, and 5 or more times).
Time frame: We will administer the PAAS to the autistic adult at Baseline and Week 16.
New General Self-Efficacy Scale (NGSE)
The NGSE is an 8-item measure that assesses how much people believe they can achieve their goals, despite difficulties. Using a 5-point rating scale (1= strongly disagree; 3 = neither agree nor disagree; 5 = strongly agree), respondents show how much they agree with eight statements, such as "Even when things are tough, I can perform quite well." Total scores are calculated by taking the average of all questions.
Time frame: We will administer the NGSE to the autistic adult at Baseline and Week 16.
Rosenberg Self-Esteem Scale (RSES)
The RSES is a 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is believed to be uni-dimensional. All items are answered using a 4-point Likert scale format ranging from strongly agree to strongly disagree.
Time frame: We will administer the RSES to the autistic adult at Baseline and Week 16.
Autism and Neurodiversity Attitudes Scale (ANAS)
The ANAS is a 17-item scale that assesses endorsements of neurodiversity beliefs with respect to autism. The ANAS also contains three subscales - Autism Anti-Stigma, Autism Permanence, and Autism as Difference. All items are answered using a 5-point Likert scale format ranging from strongly disagree to strongly agree.
Time frame: We will administer the ANAS to the autistic adult at Baseline and Week 16.
Neurodiversity Support Scale
The Neurodiversity Support Scale is a 8-item scale that assesses how strongly an individual supports the neurodiversity movement. It is adapted from Nario-Redmond et al., 2013. All items are answered using a 7-point Likert scale format ranging from strongly disagree to strongly agree with higher average scores indicting stronger support of the neurodiversity movement.
Time frame: We will administer the Neurodiversity - Movement Support to the autistic adult at Baseline and Week 16.