Clinical trial NCT05250180: Animal Assisted Therapy After Pediatric Brain Injury: Mediators and Moderators of Treatment Response.
Official title: Using Dogs to Promote Therapeutic Engagement During Inpatient Rehabilitation Following Pediatric Acquired Brain Injury: Understanding Mechanisms and Moderators of Treatment Response.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Injuries
Keywords: Pediatric brain injury
Animal assisted therapy
inpatient rehabilitation
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Miami University
name: Ohio State University
First posted: 2022-02-22
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Patient Participation/engagement
timeFrame: throughout study completion - an average of 2 weeks
measure: Objective Engagement rating.
timeFrame: throughout study completion - an average of 2 weeks
Secondary outcomes:
measure: Patient-reported mood
timeFrame: throughout study completion - an average of 2 weeks
measure: Objective mood assessment
timeFrame: throughout study completion - an average of 2 weeks
measure: Automated mood assessment
timeFrame: throughout study completion - an average of 2 weeks
measure: Physiological distress
timeFrame: throughout study completion - an average of 2 weeks
measure: Salivary Oxytocin
timeFrame: throughout study completion - an average of 2 weeks
Other outcomes:
measure: Anthropomorphism
timeFrame: throughout study completion - an average of 2 weeks
measure: Patient-animal rapport
timeFrame: throughout study completion - an average of 2 weeks
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References: