Actively Recruiting
Evaluating Additive Effects of Including Canines in Regulating Together
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-03-18
240
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective is to evaluate the potential additive effect of animal-assisted intervention (AAI) on a manualized behavioral treatment targeting emotion dysregulation (ED) in children with autism spectrum disorder (ASD). Aim 1: Evaluate whether Regulating Together-Canine demonstrates earlier and greater improvement in emotion dysregulation than Regulating Together-Standard. Aim 2: Evaluate if Regulating Together-Canine increases child engagement and learning compared to Regulating Together-Standard. Exploratory Aim: Explore association of physiological arousal (via heart rate tracking) with emotion dysregulation, treatment engagement, and learning.
CONDITIONS
Official Title
Evaluating Additive Effects of Including Canines in Regulating Together
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Concern of emotion dysregulation with a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R)
- Diagnosis of autism spectrum disorder (ASD) confirmed by an experienced clinician and supported by Autism Diagnostic Observation Schedule (ADOS-2) scoring
- Full Scale Intelligence Quotient score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II)
- English is the primary language
- Family agrees to keep prescribed medication stable during the study period
- Age between 8 years 0 months and 15 years 11 months
You will not qualify if you...
- Phobia toward or allergy to canines
- History of aggression toward animals
- Physical aggression toward other children outside the home in the past 2 weeks resulting in injury
- Major neuropsychiatric illness requiring other treatment approaches, including substance use disorders, psychotic disorders/schizophrenia, and bipolar disorder
- Major sensory impairment limiting participation, such as blindness or uncorrected hearing loss
- Lack of legal guardian available to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
C
Carrie Fassler
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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