Pilot Trial of the RUBI Program for Autistic Adults

NCT06593613 | Recruiting

• 1 other identifier: SCH STUDY00004782
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Autism Spectrum Disorder; Behavior; Parenting

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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.

  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.

  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.

  We will administer the TPA to the caregiver and autistic adult at Baseline and weekly through Week 20.

Secondary Outcomes (10)

• 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.

• Autism-Specific Parenting Self-Efficacy Scale

  We will administer the self-efficacy scale to the caregiver at Baseline and Week 16.

• Zarit-Burden Questionnaire

  We will administer the Zarit-Burden scale to the caregiver at Baseline and Week 16.

Study Arms (2)

RUBI-A

EXPERIMENTAL

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

Behavioral: RUBI-A

R-ISLEA

ACTIVE COMPARATOR

Psychoeducation control condition

Behavioral: R-ISLEA

Interventions

RUBI-A 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.

RUBI-A

R-ISLEA 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.

R-ISLEA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Els for Autism: collaborator
• Drexel University: collaborator
• University of Washington: collaborator

Study Sites (3)

Els for Autism Foundation

Jupiter, Florida, 33458, United States

NOT YET RECRUITING

A.J. Drexel Autism Institute

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Seattle Children's Autism Center

Seattle, Washington, 98115, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Daina M Tagavi, PhD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daina M Tagavi, PhD

CONTACT

206-987-0216; daina.tagavi@seattlechildrens.org

Catherine Dick, PhD

CONTACT

catherine.dick@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)