Evaluating Additive Effects of Including Canines in Regulating Together
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-15
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Regulating Together-Canine
- Regulating Together-Standard
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov