Pilot Trial of the RUBI Program for Autistic Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autism Spectrum Disorder Behavior Parenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RUBI-A

Recently redesigned version of the RUBI program for autistic adults and their caregivers

Group Type EXPERIMENTAL

RUBI-A

Intervention Type BEHAVIORAL

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

Psychoeducation control condition

Group Type ACTIVE_COMPARATOR

R-ISLEA

Intervention Type BEHAVIORAL

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.

Interventions

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RUBI-A

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.

Intervention Type BEHAVIORAL

R-ISLEA

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No