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NCT05803369Completed

DOD Regulating Together Intervention

Regulating Together: Randomized Controlled Trial Examining Predictors, Facilitators, and Barriers to Treatment Success in Emotion Dysregulation and Autism Spectrum Disorder (ASD)

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

Our long-term goal is to validate Regulating Together (emotion regulation intervention) and improve psychosocial outcomes for youth with autism spectrum disorder and emotion dysregulation.

Status (registry)
Completed
Study type
Interventional
Enrollment
125 (actual)
First submitted
14 Mar 2023
Start date
1 Aug 2022
Primary completion date
2 Jun 2026
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Diseases
Autism
NCT number
NCT05803369

What you commit to

  • Study type: Interventional
  • Participants enrolled: 125
  • From 1 Aug 2022 to the primary completion date, 2 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Initiation of new psychosocial intervention within 30 days prior to randomization/first day of treatment.

Other illness

  • 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

Other

  • any physical aggression toward other children outside the home in the past 2 weeks that resulted in serious injury

Who the study is looking for

  • Diagnosis of autism spectrum disorder (ASD)
  • A Full Scale IQ score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II) or other previous Weschler IQ test
  • Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R).
  • Caregivers and child are fluent in speaking English
  • Child functional verbal communication, confirmed via appropriateness for an Autism Diagnostic Observation Schedule (ADOS-2) Module 3.
  • Family willing to keep prescribed medication and outside interventions stable
  • willing to participate in twice weekly 90-minute sessions of either Regulating Together (RT) or Achieving Independence and Mastery in School (AIMS).
  • The guardian must provide written informed consent on behalf of the participant and the participants ages 11-12 years old must provide written informed assent to participate.

Age in the registry: 8 years to 12 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cincinnati Children's Hospital Medical Center
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.