# Evaluating additive effects of including canines in Regulating Together: A Group Treatment to Address Emotion Dysregulation in youth with autism spectrum disorder

> **NIH NIH R01** · CINCINNATI CHILDRENS HOSP MED CTR · 2022 · $683,622

## Abstract

Project Summary/Abstract
 The primary objective of this R01 application 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). ED in youth with ASD has been linked to significantly higher rates of psychiatric
hospitalizations, suicidal ideation, use of psychotropic medications, school disciplinary actions, peer rejection,
failed college and employment transitions, and poorer quality of life. Our group developed Regulating Together
(RT), an intensive group-based treatment with a concurrent parent group that employs evidence-based
intervention techniques of cognitive behavioral therapy, parent training, and mindfulness and acceptance-based
therapy. Preliminary evidence for its feasibility and efficacy has been demonstrated, including reductions in
emotional reactivity and dysphoria and increases in heart rate variability and cognitive flexibility at 10-weeks
following intervention. Despite this, change did not occur immediately post intervention. Animal Assisted
Interventions (AAI) have emerged as a promising approach for youth with ASD, demonstrating improvements in
irritability, hyperactivity, positive affect, and quality of life. AAI also has shown to increase in-session engagement
and learning. Yet, AAI has not yet been utilized to systematically target ED in ASD nor has it been examined in
conjunction with a manualized intervention.
 In the current study, we propose a multi-site randomized clinical trial of RT with and without a canine
present to evaluate its immediate and longer-term efficacy. In 240 youth (ages 8-12 years) with ASD, we will
assess RT with AAI (RT-Canine) and without AAI (RT-Standard) on primary ED symptom of reactivity, and
secondary outcomes, including dysphoria, caregiver stress, cognitive flexibility, mindfulness awareness, and
emotion regulation skills knowledge. We hypothesize that the canines will increase therapeutic engagement
measured through alliance, motivation, and improved behavior, which will then increase intervention session
level learning, and ultimately immediate and long-term intervention outcomes. Furthermore, based on our
preliminary evidence, we also will explore an objective outcomes measure of heart rate/heart rate variability and
its relationship to engagement, learning, and ED symptom outcomes.
 This proposal is relevant to the NICHD Human-Animal Interaction funding opportunity by addressing the
critical public health issue of ASD through examination of AAI efficacy by utilizing standardized data collection
outcome methods. In addition, we closely address protection for both the canines and the youth with ASD
throughout the proposal. Finally, we will make a concerted effort to include youth from minority groups, as
emphasized in the FOA. Ultimately, findings from our study have the potential to expand both ASD and AAI
research, with immense impact on ...

## Key facts

- **NIH application ID:** 10531772
- **Project number:** 1R01HD106353-01A1
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** Rebecca Shaffer
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $683,622
- **Award type:** 1
- **Project period:** 2022-09-01 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10531772

## Citation

> US National Institutes of Health, RePORTER application 10531772, Evaluating additive effects of including canines in Regulating Together: A Group Treatment to Address Emotion Dysregulation in youth with autism spectrum disorder (1R01HD106353-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10531772. Licensed CC0.

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