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NCT Number: NCT07624448

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

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy

Kansas City, Missouri, 64108, United States

Location status: Recruiting

Location contact

Grayson Manley, RN

CONTACT

[email protected]

816-816-6967

Walker McKinney, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Emotion Dysregulation Inventory - Reactivity

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

    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.

Secondary outcomes

  1. Caregiver and Child Readiness and Satisfaction Surveys

    Time frame: From enrollment to end of follow up at 15 weeks

    The investigators 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.

  2. Emotion Regulation Skills Test

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

    A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.

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

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

    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

  4. Clinician Global Impressions - Improvement (CGI-I)

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

    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.

  5. Parenting Stress Index, 4th Edition, Short Form

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

    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

  6. Aberrant Behavior Checklist, 2nd Edition (ABC-2)

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Grayson Manley, RN

CONTACT

[email protected]

816-816-6967

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: RT-ID

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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