Pilot Randomized Trial of the RUBI Program for Families of Autistic Adults

Seattle Children's Hospital3 sites in 1 country80 target enrollmentSeptember 1, 2024

ConditionsAutism Spectrum Disorder Behavior Parenting

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Autism Spectrum Disorder
Sponsor: Seattle Children's Hospital
Enrollment: 80
Locations: 3
Primary Endpoint: Emotion Dysregulation Inventory (EDI)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2024

End Date

December 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seattle Children's Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Autistic adults will:
•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);
•have receptive language \> 18 months as measured on the Mullen Scales of Early Learning (MSEL) Receptive Language subtest or similar measure of receptive language;
•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:
•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.

Outcomes

Primary Outcomes

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.

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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

Adaptive Behavior Assessment System - Third Edition (ABAS-3)(We will administer the ABAS-3 to the caregiver at Baseline and Week 20.)
World Health Organization QOL Assessment-Brief (WHO-QOL-BRIEF)(We will administer the WHO-QOL-BRIEF to the autistic adult at Baseline and Week 20.)
RUBI Knowledge Assessment and ISLEA Proximal Knowledge Measure(We will administer the knowledge questionnaire to the caregiver and autistic adult at Baseline and Week 16.)
Zarit-Burden Questionnaire(We will administer the Zarit-Burden scale to the caregiver at Baseline and Week 16.)
Autism-Specific Parenting Self-Efficacy Scale(We will administer the self-efficacy scale to the caregiver at Baseline and Week 16.)
Personal Advocacy Activity Scale (PAAS)(We will administer the PAAS to the autistic adult at Baseline and Week 16.)
New General Self-Efficacy Scale (NGSE)(We will administer the NGSE to the autistic adult at Baseline and Week 16.)
Rosenberg Self-Esteem Scale (RSES)(We will administer the RSES to the autistic adult at Baseline and Week 16.)
Autism and Neurodiversity Attitudes Scale (ANAS)(We will administer the ANAS to the autistic adult at Baseline and Week 16.)
Neurodiversity Support Scale(We will administer the Neurodiversity - Movement Support to the autistic adult at Baseline and Week 16.)