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

Study Overview
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Brief Summary
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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.

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

Conditions
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Brain Injuries

Intervention / Treatment
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* Other: Animal Assisted Therapy
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>animal assisted therapy | Other: Animal Assisted Therapy<br>* 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.<br>* Other names: AAT;|
| Active Comparator: Control<br>Treatment as usual | Other: Control<br>* treatment as usual as dictated by their treatment team<br>* Other names: Treatment as usual;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric brain injury, Animal assisted therapy, inpatient rehabilitation