Regulating Together for Intellectual Disability: A Group Behavioral Therapy for for Emotion Dysregulation in Autism and Intellectual Disability (RT-ID)

Adapting a Group Intervention for Emotion Dysregulation in Autism and Intellectual Disability

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.

Study Overview

• Status: Recruiting
• Conditions: Intellectual Disability; Autism; Intellectual Disabilities With Other Behavioral Symptoms
• Intervention / Treatment: Behavioral: Regulating Together group therapy

Detailed Description

Up to ten children with autism and co-occurring Intellectual Disability (ASD + ID) ages 8 to 12 years and their caregivers will be enrolled in the study. This study is being done to develop and test a behavior therapy to help children with ASD + ID calm their emotions. Participants will complete assessments at five time points:

Screening (T1); Week 0: Baseline visit (T2); Week 5: Post Active Treatment (T3); Week 10: 5 week follow-up (T4); and Week 15: 10 week follow-up (T5). Participants will receive 5 weeks of intervention, twice per week, following the T2 visit.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grayson Manley, RN; Phone Number: 816-816-6967; Email: gmanley@cmh.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • Children's Mercy
      • Contact: Grayson Manley, RN; Phone Number: 816-816-6967; Email: gmanley@cmh.edu
      • Principal Investigator: Walker McKinney, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Children with autism and co-occurring intellectual disability and their caregiver; Participants will receive Regulating Together - the emotion dysregulation intervention

Behavioral: Regulating Together group therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion Dysregulation Inventory - Reactivity	The Emotion Dysregulation Inventory consists of two subscales. We 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Global Impressions - Improvement (CGI-I)	A trained, independent clinician will rate the CGI at T3 and T5. The CGI-I provides a qualitative measure of treatment response through a rating from 1=very much improved to 7=very much worse.	From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Emotion Regulation Skills Test	A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.	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)	Caregiver-report measures to measure change in internalizing symptoms. For both measures: minimum raw value: 13; maximum raw value: 65; higher scores reflect greater anxiety/depression	From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Aberrant Behavior Checklist, 2nd Edition (ABC-2)	Irritability subscale; a caregiver-report measures to measure change in irritability and related challenging behaviors. Minimum score: 0; Maximum score: 45; higher scores reflect greater irritability	From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Parenting Stress Index, 4th Edition, Short Form	A caregiver-report questionnaire measuring the magnitude of stress in the parent-child system. Minimum score: 36; Maximum score: 180; Higher scores reflect greater parental stress	From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Caregiver and Child Readiness and Satisfaction Surveys	We will assess acceptability as reflected in the average caregiver and child satisfaction rating measured using two study-specific measures. Caregivers will complete the Caregiver Readiness and Satisfaction Survey and children will complete the Child Readiness and Satisfaction Survey.	From enrollment to end of follow up at 15 weeks

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: National Institutes of Health (NIH); National Center for Advancing Translational Sciences (NCATS); Frontiers Clinical & Translational Science Institute
• Investigators: Principal Investigator: Walker McKinney, PhD, Children's Mercy

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Autism; aggression; emotion dysregulation; intellectual disability
• Additional Relevant MeSH Terms: Autism Spectrum Disorder; Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Social Behavior; Autistic Disorder; Intellectual Disability; Aggression
• Other Study ID Numbers: STUDY00004069; KL2TR002367 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Risk for participant identification due to small sample and narrow geographic area

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No