Clinical trial NCT06593613: Pilot Trial of the RUBI Program for Autistic Adults
Official title: Pilot Randomized Trial of the RUBI Program for Families of Autistic Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Behavior
Parenting
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Els for Autism
name: Drexel University
name: University of Washington
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Autistic adults will:

  1. be age ≥ 18 years;
  2. live at home with their parent and be able to attend each session;
  3. have a community diagnosis of autism (confirmed through record documentation) and Social Communication Questionnaire (SCQ) total score \> 15;
  4. have a parent rated 24-item EDI Reactivity Score \> 50 percentile, which reflects mild to moderate challenging behaviors (e.g., outbursts; verbal aggression);
  5. have receptive language \> 18 months as measured on the Mullen Scales of Early Learning (MSEL) Receptive Language subtest or similar measure of receptive language;
  6. have a stable educational/vocational plan and be medication free or on stable medication (no changes in prior 6 weeks or planned changes for 16 weeks). Individuals on stable medication will be included as this enhances sample representativeness.
* Parents/Legally Authorized Representatives will be able to:

  1. attend each session.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Emotion Dysregulation Inventory (EDI)
timeFrame: 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.
measure: Open Source Challenging Behavior Scale (OS-CBS)
timeFrame: We will administer the OS-CBS to the caregiver at Baseline, Week 8, Week 16, and Week 20.
measure: Aberrant Behavior Checklist (ABC)
timeFrame: We will administer the ABC to the caregiver at Baseline and Week 20.
measure: Home Situations Questionnaire - Autism Spectrum Disorder (HSQ-ASD)
timeFrame: We will administer the HSQ-ASD to the caregiver at Baseline, Week 8, Week 16, and Week 20.
measure: Top Problems Assessment (TPA)
timeFrame: We will administer the TPA to the caregiver and autistic adult at Baseline and weekly through Week 20.
Secondary outcomes:
measure: Adaptive Behavior Assessment System - Third Edition (ABAS-3)
timeFrame: We will administer the ABAS-3 to the caregiver at Baseline and Week 20.
measure: World Health Organization QOL Assessment-Brief (WHO-QOL-BRIEF)
timeFrame: We will administer the WHO-QOL-BRIEF to the autistic adult at Baseline and Week 20.
measure: RUBI Knowledge Assessment and ISLEA Proximal Knowledge Measure
timeFrame: We will administer the knowledge questionnaire to the caregiver and autistic adult at Baseline and Week 16.
measure: Autism-Specific Parenting Self-Efficacy Scale
timeFrame: We will administer the self-efficacy scale to the caregiver at Baseline and Week 16.
measure: Zarit-Burden Questionnaire
timeFrame: We will administer the Zarit-Burden scale to the caregiver at Baseline and Week 16.
measure: Personal Advocacy Activity Scale (PAAS)
timeFrame: We will administer the PAAS to the autistic adult at Baseline and Week 16.
measure: New General Self-Efficacy Scale (NGSE)
timeFrame: We will administer the NGSE to the autistic adult at Baseline and Week 16.
measure: Rosenberg Self-Esteem Scale (RSES)
timeFrame: We will administer the RSES to the autistic adult at Baseline and Week 16.
measure: Autism and Neurodiversity Attitudes Scale (ANAS)
timeFrame: We will administer the ANAS to the autistic adult at Baseline and Week 16.
measure: Neurodiversity Support Scale
timeFrame: We will administer the Neurodiversity - Movement Support to the autistic adult at Baseline and Week 16.
Other outcomes:
Locations:
city: Jupiter
country: United States
facility: Els for Autism Foundation
state: Florida
city: Philadelphia
country: United States
facility: A.J. Drexel Autism Institute
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Autism Center
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Daina M Tagavi, PhD
role: PRINCIPAL_INVESTIGATOR
References: