Animal Assisted Therapy After Pediatric Brain Injury: Mediators and Moderators of Treatment Response.

Using Dogs to Promote Therapeutic Engagement During Inpatient Rehabilitation Following Pediatric Acquired Brain Injury: Understanding Mechanisms and Moderators of Treatment Response.

Children requiring inpatient rehabilitation treatment following acquired brain injury (ABI) are at risk for poor engagement in rehabilitative therapies. A within subject crossover design will be used to determine whether involving dogs in physical and occupational therapies while receiving inpatient rehabilitation improves patient engagement, how involving dogs improves engagement, and identify who is most likely to benefit. This project addresses the critical need to establish an evidence base for animal-assisted therapies in pediatric rehabilitation, incorporates innovative methods, and has the potential to lead to improved clinical care for children and adolescents receiving intensive rehabilitation following ABI.

Study Overview

• Status: Recruiting
• Conditions: Brain Injuries
• Intervention / Treatment: Other: Animal Assisted Therapy; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Narad, PhD; Phone Number: 15138038902; Email: megan.narad@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Megan Narad, PhD; Phone Number: 513-803-8902; Email: megan.narad@cchmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 17 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis: Participants must be admitted to the inpatient rehabilitation unit for treatment of an acquired brain injury (TBI, brain tumor, infection, etc).
• Consent: The family must provide informed consent by parents or legal guardians.
• Assent: The child/adolescent must provide a signature indicating assent to participate in the study.
• Age at the time of screening: 4-21 years old
• Sex: includes both males and females
• Responsiveness: Rancho score greater than 2 at the time of enrollment (as noted in the medical chart).

Exclusion Criteria:

• Allergies: Patient has a significant allergy to dogs
• Fear: Patient has a significant fear of dogs
• Disease: Participant is on contact precautions or has a communicable disease that may pose a risk to the dog or dog handler or has a compromised immune system where interacting with the dog and/or handler would be of significant risk to the patient.
• Medical History: History of developmental delay prior to ABI.
• Behavioral History: Participant or family has a history of animal abuse or cruelty.
• Responsiveness: Rancho score of 2 or less

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Treatment as usual	Other: Control; treatment as usual as dictated by their treatment team; Other Names: Treatment as usual
Experimental: Intervention; animal assisted therapy	Other: Animal Assisted Therapy; Patients enrolled in the study will be randomly scheduled to have a dog be a part of their PT and OT sessions on two days (one in the first week and one in the second week) during their stay. On these days, the therapist will lead the therapy session and integrate the dog at whatever level is appropriate based on the patient's level of functioning and therapy goals.; Other Names: AAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Participation/engagement	Patient engagement/participation will be assessed via the Pittsburgh Rehabilitation Participation Scale (PRPS) is a 6-item Likert-type, clinician-rated measure that quantifies observed patient participation/engagement in their therapy sessions. Therapists will report their observations regarding patient's completion of exercises, effort applied to exercises, and level of support needed to complete activities.	throughout study completion - an average of 2 weeks
Objective Engagement rating.	An objective measure of session engagement assessed via behavioral coding of video recorded therapy sessions. Coders will provide an objective measure of engagement by rating the patient in-session engagement based on the PRPS. Behaviors reflective of ratings on the PRPS will be clearly operationalized with anchors for each rating clearly defined.	throughout study completion - an average of 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported mood	Symptom Inventory Short form is a 4-item scale that asks participants to rate their level of happiness, fatigue, distraction, and irritability on a scale from 1-10.	throughout study completion - an average of 2 weeks
Objective mood assessment	Objective mood assessment will be completed via behavioral coding of session videos using Noldus Observer software. Coders will code six overarching constructs - Positive affect, negative affect, anxious-fearful affect, neutral affect, touch-physical contact, and persistence on task - with clearly defined and operationalized behaviors that contribute to each construct.	throughout study completion - an average of 2 weeks
Automated mood assessment	Automated mood assessment will be completed using Noldus FaceReader software. FaceReader is a robust automated system for the recognition of a number of specific properties in facial images, including a neutral state as well as the six basic or universal expressions - happy, sad, angry, surprised, scared, and disgusted.	throughout study completion - an average of 2 weeks
Physiological distress	Physiological variables - electrodermal activity, heart rate, and heart rate variability - will be collected continuously throughout each therapy session via Empatica E4 wristband. The average electrodermal activity, mean heart rate, heart rate variability (RMSSD: Square root of the mean squared differences of successive intervals) will be used as indicators of physiological distress during sessions.	throughout study completion - an average of 2 weeks
Salivary Oxytocin	Level of oxytocin present in patient's saliva	throughout study completion - an average of 2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropomorphism	Anthropomorphism is the tendency to attribute human like characteristics, particularly internal states and capabilities, to non-human entities. Patient level of anthropomorphism will be assessed via the 12-item Individual Differences in Anthropomorphism Questionnaire - Child Form.	throughout study completion - an average of 2 weeks
Patient-animal rapport	patient-animal rapport will be assessed via the patient-animal closeness measure. Patients are presented with 7 images and asked to select a number between 1 and 7 that best describes the amount of overlap between the patient and the dog.	throughout study completion - an average of 2 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Ohio State University; Miami University

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Animal assisted therapy; Pediatric brain injury; inpatient rehabilitation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries
• Other Study ID Numbers: Cin AAT for ABI; 1R01HD106416 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No