Recruiting

RUBI Program

Sponsor:

Seattle Children's Hospital

Code:

NCT06593613

Conditions

Autism Spectrum Disorder

Behavior

Parenting

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RUBI-A

R-ISLEA

Study Details

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

Study ID

NCT06593613

Start date

Sep 1, 2024

Status verified date

Sep, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RUBI-A

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

active comparator: R-ISLEA

Psychoeducation control condition

Interventions

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.

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.

Primary outcome measure

  • 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. ]
  • 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. ]
  • Aberrant Behavior Checklist (ABC) [ Time Frame: We will administer the ABC to the caregiver at Baseline and Week 20. ]
  • 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. ]
  • Top Problems Assessment (TPA) [ Time Frame: We will administer the TPA to the caregiver and autistic adult at Baseline and weekly through Week 20. ]

Central Contacts and Locations

Central contacts

Daina M Tagavi, PhD

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

Catherine Dick, PhD

catherine.dick@seattlechildrens.org

Locations

Seattle Children's Autism Center

Recruiting

Seattle, Washington, United States, 98115

Contacts

Daina M Tagavi, PhD

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

Catherine Dick, PhD

catherine.dick@seattlechildrens.org

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2024-09-19.