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New treatment option for Autism Spectrum Disorder
Official title Evaluating Additive Effects of Including Canines in Regulating Together
ClinicalTrials.gov ID: NCT05803343
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 15
You may be able to join if
- 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...
- A Full Scale Intelligence Quotient score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II)
- English is the primary language
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 15 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.