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

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Brain Injuries

Treatments: Other: Animal Assisted Therapy; Other: Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05250180

1R01HD106416 (U.S. NIH Grant/Contract)

Cin AAT for ABI

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 4 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Intervention

Experimental group

Description:

animal assisted therapy

Treatment:

Other: Animal Assisted Therapy

Control

Active Comparator group

Description:

Treatment as usual

Treatment:

Other: Control