NCT05803343 Evaluating Additive Effects of Including Canines in Regulating Together
| NCT ID | NCT05803343 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-02-28 |
| Primary Completion | 2028-01-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2023-02-28 with a primary completion date of 2028-01-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Participant has a phobia toward or is allergic to canines * Participant has a history of aggression toward animals * Participant has had any physical aggression toward other children outside the home in the past 2 weeks that resulted in injury * 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 * A legal guardian is not available to provide informed consent
Contact & Investigator
Rebecca Shaffer, Psy.D.
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT05803343 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 15 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05803343 currently recruiting?
Yes, NCT05803343 is actively recruiting participants. Contact the research team at carrie.fassler@cchmc.org for enrollment information.
Where is the NCT05803343 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT05803343 clinical trial?
NCT05803343 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Rebecca Shaffer, Psy.D. at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 240 participants.