Brain Injuries
Conditions
Keywords
Pediatric brain injury, Animal assisted therapy, inpatient rehabilitation
Brief summary
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.
Interventions
OTHERAnimal 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.
OTHERControl
treatment as usual as dictated by their treatment team
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Miami University
Ohio State University
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 24 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Engagement rating. | throughout study completion - an average of 2 weeks | 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. |
| Patient Participation/engagement | throughout study completion - an average of 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective mood assessment | throughout study completion - an average of 2 weeks | 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. |
| Physiological distress | throughout study completion - an average of 2 weeks | 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. |
| Salivary Oxytocin | throughout study completion - an average of 2 weeks | Level of oxytocin present in patient's saliva |
| Automated mood assessment | throughout study completion - an average of 2 weeks | 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. |
| Patient-reported mood | throughout study completion - an average of 2 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anthropomorphism | throughout study completion - an average of 2 weeks | 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. |
| Patient-animal rapport | throughout study completion - an average of 2 weeks | 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. |
Countries
United States
Contacts
Primary ContactMegan Narad, PhD
Outcome results
None listed