NCT05803343Recruiting
Evaluating Additive Effects of Including Canines in Regulating Together
Evaluating Additive Effects of Including Canines in Regulating Together: A Group Treatment to Address Emotion Dysregulation in Youth With Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 15 Mar 2023
- Start date
- 28 Feb 2023
- Primary completion date
- 21 Jan 2028
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Autism
- NCT number
- NCT05803343
What you commit to
- Study type: Interventional
- Planned participants: 240
- From 28 Feb 2023 to the primary completion date, 21 Jan 2028
- 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.
Other illness
- Participant has a phobia toward or is allergic to canines
- Participant has a history of aggression toward animals
- Presence of comorbid major neuropsychiatric illness warranting other treatment approaches as determined by the study clinician(s) including substance use disorders, psychotic disorders/schizophrenia, and bipolar disorder, among others
- Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
Other
- Participant has had any physical aggression toward other children outside the home in the past 2 weeks that resulted in injury
- A legal guardian is not available to provide informed consent
Who the study is looking for
- Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R)
- Diagnosis of autism spectrum disorder (ASD)
- Diagnosis confirmed by an experienced ASD clinician and further supported by scoring in the range for ASD on the Autism Diagnostic Observation Schedule (ADOS-2)
- A 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 over the course of the study period
Age in the registry: 8 years to 15 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile 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 | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.