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.
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.
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
Single group
Regulating Together group therapy
BehavioralRegulating Together is the original curriculum developed for autistic youth that uses evidence-based therapeutic strategies including relaxation techniques, parent management training, and mindfulness to help regulate emotions. This study will adapt the original Regulating Together curriculum to focus on behavioral interventions to treat emotion dysregulation in Autism with a co-occurring intellectual disability.
Emotion Dysregulation Inventory - Reactivity
The Emotion Dysregulation Inventory consists of two subscales. The investigators will use the Reactivity subscale which captures poorly regulated negative emotional responses and a dysphoria subscale characterized by increased negative affect and lack of motivation. Minimum raw score: 0; Maximum raw score: 96; Higher scores reflect higher emotional reactivity.
Caregiver and Child Readiness and Satisfaction Surveys
The investigators will assess acceptability as reflected in the average caregiver and child satisfaction rating measured using two study-specific measures. Caregivers will complete the Caregiver Readiness and Satisfaction Survey and children will complete the Child Readiness and Satisfaction Survey.
Emotion Regulation Skills Test
A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression Scales (Parent-Proxy)
Caregiver-report measures to measure change in internalizing symptoms. For both measures: minimum raw value: 13; maximum raw value: 65; higher scores reflect greater anxiety/depression
Clinician Global Impressions - Improvement (CGI-I)
A trained, independent clinician will rate the CGI at T3 and T5. The CGI-I provides a qualitative measure of treatment response through a rating from 1=very much improved to 7=very much worse.
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Children's Mercy Hospital Kansas City
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator
