Evaluating Additive Effects of Including Canines in Regulating Together

Autism Spectrum Disorder Clinical Trial

Official title:

Evaluating Additive Effects of Including Canines in Regulating Together: A Group Treatment to Address Emotion Dysregulation in Youth With Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05803343
• Other study ID #: 1R01HD106353
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: July 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Carrie Fassler
• Phone: 513-803-3580
• Email: carrie.fassler[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Emotion Regulation

Intervention

Behavioral:
• Regulating 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.
• Regulating 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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion