About this trial
The goal of this study is to help children with autism and a co-occurring intellectual disability and their families learn practical strategies for managing issues like irritability, aggression, and other challenging behaviors. The main objective of this study is:
To adapt current Regulating Together materials to create an outpatient group program for emotion dysregulation in autism and co-occurring intellectual disability (ASD + ID) that will improve psychosocial outcomes for youth with ASD + ID.
Eligibility criteria
Qualifiers
Males, females, or non-binary youth between 8 and 12 years of age
Confirmed diagnosis of Autism Spectrum Disorder (ASD)
Confirmed diagnosis of Intellectual Disability
Fluent in spoken English.
Disqualifiers
Initiation of new psychosocial intervention within 30 days prior to first day of treatment
Presence of physical aggression in the child directed towards a peer outside the home (i.e., non-siblings) that resulted in injury within 30 days prior to screening. Other significant disruptive, aggressive, self-injurious, or sexually inappropriate behavior felt to be dangerous or overly disruptive to the group sessions will be reviewed by the study team on an individual basis.
Presence of comorbid major neuropsychiatric illness warranting other treatment approaches
Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
Trial design
Treatments tested in this trial
- Regulating Together group therapy
Treatment groups
Sponsors and collaborators
Children's Mercy Hospital Kansas City
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator