Status:
RECRUITING
Pilot Trial of the RUBI Program for Autistic Adults
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Els for Autism
Drexel University
Conditions:
Autism Spectrum Disorder
Behavior
Eligibility:
All Genders
18+ years
Phase:
NA
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-occurr...
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06593613
Start Date
September 1 2024
End Date
December 31 2024
Last Update
September 19 2024
Active Locations (3)
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1
Els for Autism Foundation
Jupiter, Florida, United States, 33458
2
A.J. Drexel Autism Institute
Philadelphia, Pennsylvania, United States, 19104
3
Seattle Children's Autism Center
Seattle, Washington, United States, 98115