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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Regulating Together-Canine
BehavioralRT-C is an animal assisted, intensive outpatient group intervention for children with autism spectrum disorder and emotion dysregulation. RT-C meets for 1.5 hours, twice weekly for five weeks with concurrent youth and caregiver groups. The children progress through skills including relaxation training, arousal ratings, problem size, mindfulness, problem solving, and cognitive flexibility. The caregivers learn crisis management, reward systems, and coaching strategies for topics taught to the children. Homework is utilized to reinforce use of skills outside the group. The canines are present throughout as both a calming presence and teaching assistant. Children will be able to interact with the dog when practicing relaxation at the beginning of each session and throughout the session. Additionally, the dog will help to emphasize certain curriculum concepts.
Regulating Together-Standard
BehavioralRT-S an established, intensive outpatient group intervention for children with autism spectrum disorder and emotion dysregulation. It engages both caregivers and children and utilizes evidence-based intervention techniques including cognitive behavioral therapy (CBT), visuals, reinforcements, and scaffolding, and newer interventions such as mindfulness and acceptance-based therapy.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Regulating Together-Canine (RT-Canine)Experimental treatment 1 intervention
Group B: Regulating Together-Standard (RT-Standard)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Emotion Dysregulation Inventory-Reactivity (EDI-R)
The EDI-R is a parent-report measure that consists of two scales, Reactivity which captures poorly regulated negative emotional responses and Dysphoria characterized by decreased uptake of positive affect and lack of motivation. Higher scores indicate higher emotional reactivity.
Time frame
Through study completionSponsors and contacts
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Source ClinicalTrials.gov