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

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

Plain Language Summary

Simplified for easier understanding

This study tests whether including trained therapy dogs in a structured emotion regulation program makes the program more effective for children with autism spectrum disorder (ASD) who struggle with emotion dysregulation. Many children with autism experience intense, rapid, and difficult-to-manage emotional reactions — outbursts, meltdowns, and extreme distress — that significantly impair daily life, family functioning, and school participation. The base program being tested is called Regulating Together, a structured group intervention designed to teach children and parents co-regulation skills. The study adds trained canine-assisted therapy sessions to see whether the presence of a therapy dog enhances engagement, emotional calming, and learning. Eligible participants are children aged 8 to 15 with a confirmed ASD diagnosis, significant emotion dysregulation on a standardized scale, an IQ of 65 or above, and English as their primary language. Children who have a phobia of or allergy to dogs, a history of aggression toward animals, recent physical aggression toward other children resulting in injury, serious co-occurring psychiatric conditions, or major sensory impairments are not eligible. Children and their parents participate in the Regulating Together program with or without canine-assisted sessions and are assessed on emotion dysregulation, behavioral symptoms, and quality of life at multiple points. This research is important because emotion dysregulation is one of the most impactful and least treated aspects of autism in childhood, and evidence-based programs that are both effective and engaging for this population are urgently needed.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

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NCT05803343


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