Regulating Together for Intellectual Disability and Autism: A Group Behavioral Therapy for for Emotion Dysregulation

NCT07624448 | Recruiting

• 2 other identifiers: STUDY00004069KL2TR002367
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism; Intellectual Disability; Intellectual Disabilities With Other Behavioral Symptoms

Keywords

Autism; intellectual disability; emotion dysregulation; aggression

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Secondary Outcomes (6)

• Caregiver and Child Readiness and Satisfaction Surveys

  From enrollment to end of follow up at 15 weeks

• Emotion Regulation Skills Test

  From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

• Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression Scales (Parent-Proxy)

  From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

• Clinician Global Impressions - Improvement (CGI-I)

  From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

• Parenting Stress Index, 4th Edition, Short Form

  From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Study Arms (1)

Children with autism and co-occurring intellectual disability and their caregiver

EXPERIMENTAL

Participants will receive Regulating Together - the emotion dysregulation intervention

Behavioral: Regulating Together group therapy

Interventions

Regulating Together group therapy BEHAVIORAL

Regulating 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.

Children with autism and co-occurring intellectual disability and their caregiver

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• Children's Mercy Hospital Kansas City: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Children's Mercy

Kansas City, Missouri, 64108, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Intellectual Disability; Aggression

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Study Officials

• Walker McKinney, PhD

  Children's Mercy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grayson Manley, RN

CONTACT

816-816-6967; gmanley@cmh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)