Recruiting

Regulating Together

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT07624448

Conditions

Autism

Intellectual Disabilities With Other Behavioral Symptoms

Intellectual Disability

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

Interventions

Regulating Together group therapy

Study Details

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 Disabilities With Other Behavioral Symptoms

Intellectual Disability

Study ID

NCT07624448

Start date

Oct, 2027

Status verified date

Sep, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Participants will receive Regulating Together - the emotion dysregulation intervention

Interventions

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.

Primary outcome measure

  • Emotion Dysregulation Inventory - Reactivity [ Time Frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed ]

Central Contacts and Locations

Central contacts

Grayson Manley, RN

816-816-6967gmanley@cmh.edu

Locations

Children's Mercy

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Grayson Manley, RN

816-816-6967gmanley@cmh.edu

Principal Investigator:

Walker McKinney, PhD

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Autism
  • intellectual disability
  • emotion dysregulation
  • aggression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City on 2026-09-03.