NCT07624448 · RECRUITING
Regulating Together for Intellectual Disability and Autism: A Group Behavioral Therapy for for Emotion Dysregulation
This study is adapting and testing a group behavioral program called Regulating Together. It is for children ages 8 to 12 with autism and intellectual disability, and for their parents. The goal is to help families manage irritability, aggression, and other hard behaviors. It is not a drug and not a phase-rated trial. It is an early program-building study.
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-09-03