RECRUITING

Pilot Trial of the RUBI Program for Autistic Adults

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06593613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Autistic adults will:
  2. 1. be age ≥ 18 years;
  3. 2. live at home with their parent and be able to attend each session;
  4. 3. have a community diagnosis of autism (confirmed through record documentation) and Social Communication Questionnaire (SCQ) total score \> 15;
  5. 4. have a parent rated 24-item EDI Reactivity Score \> 50 percentile, which reflects mild to moderate challenging behaviors (e.g., outbursts; verbal aggression);
  6. 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;
  7. 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.
  8. * Parents/Legally Authorized Representatives will be able to:
  9. 1. attend each session.
  1. * 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.
  2. * Parents/Legally Authorized Representatives where they are unable to attend weekly virtual or in person sessions over the course of 20 weeks.

Contacts and Locations

Study Contact

Daina M Tagavi, PhD
CONTACT
206-987-0216
daina.tagavi@seattlechildrens.org
Catherine Dick, PhD
CONTACT
catherine.dick@seattlechildrens.org

Principal Investigator

Daina M Tagavi, PhD
PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital

Study Locations (Sites)

Els for Autism Foundation
Jupiter, Florida, 33458
United States
A.J. Drexel Autism Institute
Philadelphia, Pennsylvania, 19104
United States
Seattle Children's Autism Center
Seattle, Washington, 98115
United States

Collaborators and Investigators

Sponsor: Seattle Children's Hospital

  • Daina M Tagavi, PhD, PRINCIPAL_INVESTIGATOR, Seattle Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2024-09-01
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Behavior
  • Parenting