Back to resultsEvaluating Additive Effects of Including Canines in Regulating Together
Primary Purpose
Autism Spectrum Disorder, Emotion Regulation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regulating Together-Canine
Regulating Together-Standard
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
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
Sites / Locations
- Cincinnati Children's Hospital Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Regulating Together-Canine (RT-Canine)
Regulating Together-Standard (RT-Standard)
Arm Description
Participants in this Arm will receive the Regulating Together-Canine intervention.
Participants in this Arm will receive the Regulating Together-Standard intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05803343
First Posted
March 15, 2023
Last Updated
July 27, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT05803343
Brief Title
Evaluating Additive Effects of Including Canines in Regulating Together
Official Title
Evaluating Additive Effects of Including Canines in Regulating Together: A Group Treatment to Address Emotion Dysregulation in Youth With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Emotion Regulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Regulating Together-Canine (RT-Canine)
Arm Type
Experimental
Arm Description
Participants in this Arm will receive the Regulating Together-Canine intervention.
Arm Title
Regulating Together-Standard (RT-Standard)
Arm Type
Active Comparator
Arm Description
Participants in this Arm will receive the Regulating Together-Standard intervention.
Intervention Type
Behavioral
Intervention Name(s)
Regulating Together-Canine
Other Intervention Name(s)
RT-Canine, RT-C
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Regulating Together-Standard
Other Intervention Name(s)
RT-Standard, RT-S
Intervention Description
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 Information:
Title
Emotion Dysregulation Inventory-Reactivity (EDI-R)
Description
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.
Time Frame
Through study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carrie Fassler
Phone
513-803-3580
Email
carrie.fassler@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Shaffer, Psy.D.
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Fassler
Phone
513-803-3580
Email
carrie.fassler@cchmc.org
First Name & Middle Initial & Last Name & Degree
Rebecca Shaffer, Psy.D.
12. IPD Sharing Statement
Learn more about this trial
Evaluating Additive Effects of Including Canines in Regulating Together
We'll reach out to this number within 24 hrs