RECRUITING

Evaluating Additive Effects of Including Canines in Regulating Together

Conditions

Autism Spectrum Disorder Emotion Regulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-28

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05803343

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 15 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Carrie Fassler

CONTACT

513-803-3580

carrie.fassler@cchmc.org

Principal Investigator

Rebecca Shaffer, Psy.D.

PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Rebecca Shaffer, Psy.D., PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-28

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-02-28

Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

Autism Spectrum Disorder
Emotion Regulation