Evaluating Additive Effects of Including Canines in Regulating Together

Cincinnati Children's Hospital Medical Center

Status and phase: Enrolling; Phase 2

Conditions: Autism Spectrum Disorder; Emotion Regulation

Treatments: Behavioral: Regulating Together-Canine; Behavioral: Regulating Together-Standard

Study type: Interventional

Funder types: Other

Identifiers

NCT05803343

1R01HD106353

Details and patient eligibility

About

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.

Full 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).

Enrollment: 240 estimated patients

Sex: All

Ages: 8 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Regulating Together-Canine (RT-Canine)

Experimental group

Description:

Participants in this Arm will receive the Regulating Together-Canine intervention.

Treatment:

Behavioral: Regulating Together-Canine

Regulating Together-Standard (RT-Standard)

Active Comparator group

Description:

Participants in this Arm will receive the Regulating Together-Standard intervention.

Treatment:

Behavioral: Regulating Together-Standard