Actively Recruiting
Evaluating Additive Effects of Including Canines in Regulating Together: A Group Treatment to Address Emotion Dysregulation in Youth With Autism Spectrum Disorder
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-03-18
240
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating whether adding animal-assisted intervention (AAI) with canines to a manualized behavioral treatment can improve emotion dysregulation in children with autism spectrum disorder (ASD). The study aims to compare the effects of the Regulating Together-Canine program against the standard version without dogs, focusing on improvements in emotion regulation, child engagement, and learning. It also explores how physiological arousal, measured through heart rate tracking, relates to emotion dysregulation and treatment outcomes. Children aged 8 to 15 with ASD and emotion dysregulation will be randomly assigned to one of two group treatments: Regulating Together-Canine (RT-C) or Regulating Together-Standard (RT-S). Both interventions involve intensive outpatient group sessions twice weekly for five weeks, including concurrent groups for youth and caregivers. RT-C includes the presence of a dog that supports relaxation and curriculum concepts, while RT-S uses evidence-based behavioral techniques without animal assistance. Participants will attend five research visits and complete assessments at screening, baseline, post-treatment, and follow-ups at 10 weeks and 6 months after treatment. Measures include emotion dysregulation inventory scores and heart rate monitoring. Caregivers and children will complete questionnaires and engage in skill-building activities with homework to reinforce learning. The study evaluates emotion regulation changes and treatment engagement over time, with safety and progress monitored throughout the trial period.
CONDITIONS
Brief Title
Evaluating Additive Effects of Including Canines in Regulating Together
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged between 8 years 0 months and 15 years 11 months
- Diagnosis of autism spectrum disorder confirmed by an experienced clinician and supported by Autism Diagnostic Observation Schedule (ADOS-2) scores
- Concern of emotion dysregulation with a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R)
- Full Scale Intelligence Quotient score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II)
- English is the primary language
- Family willing to keep prescribed medication stable during the study period
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 within the past 2 weeks that resulted in injury
- Major neuropsychiatric illnesses requiring other treatments, including substance use disorders, psychotic disorders, schizophrenia, or bipolar disorder
- Major sensory impairments limiting participation, such as blindness or uncorrected hearing loss
- No legal guardian available to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants take part in an intensive outpatient group intervention involving children and caregivers. The intervention occurs twice weekly for five weeks, with sessions lasting 1.5 hours each. Participants are randomly assigned to either Regulating Together-Canine (with dogs) or Regulating Together-Standard (without dogs).
10 group sessions over 5 weeks
Duration - 6 months
Participants complete outcome assessments at 1-2 weeks, 10 weeks, and 6 months after treatment completion to evaluate progress and emotion dysregulation.
4 visits (1 baseline, 1 post-treatment, 1 at 10 weeks, 1 at 6 months)
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
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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