DOD Regulating Together Intervention (NCT05803369) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
DOD Regulating Together Intervention
United States144 participantsStarted 2022-08-01
Plain-language summary
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.
Who can participate
Age range8 Years – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Initiation of new psychosocial intervention within 30 days prior to randomization/first day of treatment.
* any physical aggression toward other children outside the home in the past 2 weeks that resulted in serious injury
* 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
What they're measuring
1
Emotion Dysregulation Inventory- Reactivity
Timeframe: Through study completion, about 29 weeks
Trial details
NCT IDNCT05803369
SponsorChildren's Hospital Medical Center, Cincinnati