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.

Overview

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

• Other Animal 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.
• Other Control
  treatment as usual as dictated by their treatment team

Primary outcome measures

• Patient Participation/engagement [Time frame: throughout study completion - an average of 2 weeks]
• Objective Engagement rating. [Time frame: throughout study completion - an average of 2 weeks]

Secondary outcome measures (5)

• Patient-reported mood [Time frame: throughout study completion - an average of 2 weeks]
• Objective mood assessment [Time frame: throughout study completion - an average of 2 weeks]
• Automated mood assessment [Time frame: throughout study completion - an average of 2 weeks]
• Physiological distress [Time frame: throughout study completion - an average of 2 weeks]
• Salivary Oxytocin [Time frame: throughout study completion - an average of 2 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Cincinnati Children's Hospital Medical Center — Cincinnati

Identifiers

NCT: NCT05250180 · Cin AAT for ABI · 1R01HD106416

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗