RecruitingNot ApplicableNCT05803343

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

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

240 participants

Start Date

Feb 28, 2023

Study Type

INTERVENTIONAL

Conditions

Autism Spectrum Disorder Emotion Regulation

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

Min Age: 8 YearsMax Age: 15 Years

Inclusion Criteria6

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 Criteria6

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

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Interventions

BEHAVIORALRegulating Together-Canine

RT-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.

BEHAVIORALRegulating Together-Standard

RT-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.