Evaluating Additive Effects of Including Canines in Regulating Together

Conditions

• Autism Spectrum Disorder
• Emotion Regulation

Eligibility Criteria

Sex

ALL

Age

8 Years - 15 Years

Healthy Volunteers

Not accepted

Interventions

• Regulating Together-Canine — BEHAVIORAL
  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 — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Feb 28, 2023

Status verified

Mar 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Emotion Dysregulation Inventory-Reactivity (EDI-R) [ Time Frame: Through study completion ]

Central Contacts

• Carrie Fassler
  513-803-3580
  [email protected]

Locations (1)

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