Using Dogs to Promote Therapeutic Engagement During Inpatient Rehabilitation Following Pediatric Acquired Brain Injury: Understanding Mechanisms and Moderators of Treatment Response.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Injuries
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Patient Participation/engagement
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Patient Participation/engagement
Time Frame: 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.
Objective Engagement rating.
Time Frame: 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.
Secondary Outcomes
- Patient-reported mood(throughout study completion - an average of 2 weeks)
- Automated mood assessment(throughout study completion - an average of 2 weeks)
- Objective mood assessment(throughout study completion - an average of 2 weeks)
- Physiological distress(throughout study completion - an average of 2 weeks)
- Salivary Oxytocin(throughout study completion - an average of 2 weeks)