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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
Related publications
- Regulating Together: Caregivers' experiences in a shared journey through an emotion dysregulation intervention for autistic youth.Res Dev Disabil · 2026 · PMID 42217453
This page is information, not medical advice. Discuss any trial with your doctor.