Regulating Together for Emotion Dysregulation in ASD and Intellectual Disability (group therapy)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study adapts Regulating Together materials into an outpatient, group-based program for children with ASD and ID who have emotion dysregulation. Up to ten children aged 8–12 and their caregivers will participate in 5 weeks of twice-weekly, 90-minute sessions, with assessments at five time points (baseline, post-treatment, and follow-ups at weeks 10 and 15). The program aims to improve psychosocial outcomes by teaching emotion regulation strategies and monitoring changes over time. Safety and eligibility criteria ensure participants have diagnosed ASD and ID, English fluency, and willingness to maintain stable medications and outside therapies during the study.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Mercy
  Kansas City, Missouri, United States Recruiting

Study contacts

• Principal investigator: Walker McKinney, PhD — Children's Mercy
• Study coordinator: Grayson Manley, RN
• Email: gmanley@cmh.edu
• Phone: 816-816-6967

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.