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

Brain Injuries Clinical Trial

Official title:

Using Dogs to Promote Therapeutic Engagement During Inpatient Rehabilitation Following Pediatric Acquired Brain Injury: Understanding Mechanisms and Moderators of Treatment Response.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250180
• Other study ID #: Cin AAT for ABI
• Secondary ID: 1R01HD106416
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Megan Narad, PhD
• Phone: 15138038902
• Email: megan.narad[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Miami University, Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropomorphism	Anthropomorphism is the tendency to attribute human like characteristics, particularly internal states and capabilities, to non-human entities. Patient level of anthropomorphism will be assessed via the 12-item Individual Differences in Anthropomorphism Questionnaire - Child Form.	throughout study completion - an average of 2 weeks
Other	Patient-animal rapport	patient-animal rapport will be assessed via the patient-animal closeness measure. Patients are presented with 7 images and asked to select a number between 1 and 7 that best describes the amount of overlap between the patient and the dog.	throughout study completion - an average of 2 weeks
Primary	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
Primary	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	Patient-reported mood	Symptom Inventory Short form is a 4-item scale that asks participants to rate their level of happiness, fatigue, distraction, and irritability on a scale from 1-10.	throughout study completion - an average of 2 weeks
Secondary	Objective mood assessment	Objective mood assessment will be completed via behavioral coding of session videos using Noldus Observer software. Coders will code six overarching constructs - Positive affect, negative affect, anxious-fearful affect, neutral affect, touch-physical contact, and persistence on task - with clearly defined and operationalized behaviors that contribute to each construct.	throughout study completion - an average of 2 weeks
Secondary	Automated mood assessment	Automated mood assessment will be completed using Noldus FaceReader software. FaceReader is a robust automated system for the recognition of a number of specific properties in facial images, including a neutral state as well as the six basic or universal expressions - happy, sad, angry, surprised, scared, and disgusted.	throughout study completion - an average of 2 weeks
Secondary	Physiological distress	Physiological variables - electrodermal activity, heart rate, and heart rate variability - will be collected continuously throughout each therapy session via Empatica E4 wristband. The average electrodermal activity, mean heart rate, heart rate variability (RMSSD: Square root of the mean squared differences of successive intervals) will be used as indicators of physiological distress during sessions.	throughout study completion - an average of 2 weeks
Secondary	Salivary Oxytocin	Level of oxytocin present in patient's saliva	throughout study completion - an average of 2 weeks