Animal Assisted Therapy After Pediatric Brain Injury: Mediators and Moderators of Treatment Response.
Using Dogs to Promote Therapeutic Engagement During Inpatient Rehabilitation Following Pediatric Acquired Brain Injury: Understanding Mechanisms and Moderators of Treatment Response.
2 other identifiers
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2022
CompletedFirst Posted
Study publicly available on registry
February 22, 2022
CompletedStudy Start
First participant enrolled
July 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedMay 8, 2025
May 1, 2025
3.7 years
January 21, 2022
May 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient Participation/engagement
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.
throughout study completion - an average of 2 weeks
Objective Engagement rating.
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.
throughout study completion - an average of 2 weeks
Secondary Outcomes (5)
Patient-reported mood
throughout study completion - an average of 2 weeks
Objective mood assessment
throughout study completion - an average of 2 weeks
Automated 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
Other Outcomes (2)
Anthropomorphism
throughout study completion - an average of 2 weeks
Patient-animal rapport
throughout study completion - an average of 2 weeks
Study Arms (2)
Intervention
EXPERIMENTALanimal assisted therapy
Control
ACTIVE COMPARATORTreatment as usual
Interventions
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.
treatment as usual as dictated by their treatment team
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2022
First Posted
February 22, 2022
Study Start
July 22, 2022
Primary Completion
April 1, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
May 8, 2025
Record last verified: 2025-05