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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07624448). StuddyBuddy aggregates publicly available trial information.