NCT05803343NARecruiting

Evaluating Additive Effects of Including Canines in Regulating Together

Children's Hospital Medical Center, Cincinnati

Start Date

2/28/2023

Completion Date

1/21/2028

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.

Detailed Description

Children between the ages of 8 years 0 months and 15 years 11 months with Autism Spectrum Disorder (ASD) and emotion dysregulation (ED) and their caregivers will participate in 5 research visits and 10 group intervention sessions. They are randomly assigned to either Regulating Together-Standard group (no dog), or Regulating Together-Canine group (with dog). Characterization measures will be completed at Screen (T1). All outcome measures will be completed at Baseline (T2), Post-treatment (1-2 weeks following treatment completion, T3), 10 week post treatment completion follow up (T4), and 6 month post treatment completion follow up (T5).

Eligibility Criteria

Age Range: 8 years to 15 years

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

Interventions

BEHAVIORAL

Regulating Together-Canine

BEHAVIORAL

Regulating Together-Standard

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Conditions

Autism Spectrum DisorderEmotion Regulation

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States