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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 15
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Carrie Fassler
carrie.fassler@cchmc.org
513-803-3580
Time Frame
Start Date: 2023-02-28
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 240
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov