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Recruiting
NCT07624448
Regulating Together for Intellectual Disability: A Group Behavioral Therapy for for Emotion Dysregulation in Autism and Intellectual Disability
Conditions: Autism, Intellectual Disabilities With Other Behavioral Symptoms, Intellectual Disability
Sex: All
Ages: 8 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Children's Mercy Hospital Kansas City
Location: Children's Mercy Kansas City Missouri
Summary
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
Child Participant Inclusion Criteria:
* 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.
* Use of flexible phrase speech or greater
* Meeting clinically significant emotion dysregulation criteria
* Willing to participate in twice weekly 90-minute sessions
* Family is willing to keep prescribed psychiatric medication and outside behavioral interventions stable
* Parent, guardian, or legally authorized representative (LAR) must provide written permission on behalf of the participant
Child Participant Exclusion Criteria:
* 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
Caregiver Inclusion Criteria:
* Age ≥ 18 years
* Lives and cares for their child with ASD+ID for \> 50% of the year
* Fluent in spoken English.
* Willing to participate in twice weekly 90-minute sessions, including one virtual session weekly
Caregiver Exclusion Criteria:
-Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
Source: ClinicalTrials.gov (NCT07624448). StuddyBuddy aggregates publicly available trial information.