Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT05803369
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
12 Years
Study:
NCT05803369
Study Brief:
Protocol Section:
NCT05803369