Evaluating Additive Effects of Including Canines in Regulating Together
NCT ID: NCT05803343
Last Updated: 2024-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2023-02-28
2027-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Regulating Together-Canine (RT-Canine)
Participants in this Arm will receive the Regulating Together-Canine intervention.
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-Standard)
Participants in this Arm will receive the Regulating Together-Standard intervention.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
8 Years
15 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Rebecca Shaffer, Psy.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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