Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05803343

Conditions

Autism Spectrum Disorder

Emotion Regulation

Eligibility Criteria

Sex: All

Age: 8 - 15

Healthy Volunteers: Not accepted

Interventions

Regulating Together-Canine

Regulating Together-Standard

Study Details

Brief 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.

Conditions

Autism Spectrum Disorder

Emotion Regulation

Study ID

NCT05803343

Start date

Feb 28, 2023

Status verified date

Jul, 2026

Completion date

Jan 21, 2028

Anticipated

Primary completion date

Jan 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 15

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Regulating Together-Canine (RT-Canine)

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

active comparator: Regulating Together-Standard (RT-Standard)

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

Interventions

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.

Primary outcome measure

  • Emotion Dysregulation Inventory-Reactivity (EDI-R) [ Time Frame: Through study completion ]

Central Contacts and Locations

Central contacts

Carrie Fassler

513-803-3580carrie.fassler@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Carrie Fassler

5138033580carrie.fassler@cchmc.org

Principal Investigator:

Rebecca Shaffer, Psy.D.

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-07-08.