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

Primary Purpose

Brain Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Animal Assisted Therapy
Control
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring Pediatric brain injury, Animal assisted therapy, inpatient rehabilitation

Eligibility Criteria

4 Years - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

animal assisted therapy

Treatment as usual

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Salivary Oxytocin
Level of oxytocin present in patient's saliva

Full Information

First Posted
January 21, 2022
Last Updated
June 13, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Miami University, Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05250180
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
September 20, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Miami University, Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
Pediatric brain injury, Animal assisted therapy, inpatient rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
animal assisted therapy
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Treatment as usual
Intervention Type
Other
Intervention Name(s)
Animal Assisted Therapy
Other Intervention Name(s)
AAT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Treatment as usual
Intervention Description
treatment as usual as dictated by their treatment team
Primary Outcome Measure Information:
Title
Patient Participation/engagement
Description
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.
Time Frame
throughout study completion - an average of 2 weeks
Title
Objective Engagement rating.
Description
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.
Time Frame
throughout study completion - an average of 2 weeks
Secondary Outcome Measure Information:
Title
Patient-reported mood
Description
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.
Time Frame
throughout study completion - an average of 2 weeks
Title
Objective mood assessment
Description
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.
Time Frame
throughout study completion - an average of 2 weeks
Title
Automated mood assessment
Description
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.
Time Frame
throughout study completion - an average of 2 weeks
Title
Physiological distress
Description
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.
Time Frame
throughout study completion - an average of 2 weeks
Title
Salivary Oxytocin
Description
Level of oxytocin present in patient's saliva
Time Frame
throughout study completion - an average of 2 weeks
Other Pre-specified Outcome Measures:
Title
Anthropomorphism
Description
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.
Time Frame
throughout study completion - an average of 2 weeks
Title
Patient-animal rapport
Description
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.
Time Frame
throughout study completion - an average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Narad, PhD
Phone
15138038902
Email
megan.narad@cchmc.org
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Narad, PhD
Phone
513-803-8902
Email
megan.narad@cchmc.org

12. IPD Sharing Statement

Learn more about this trial

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

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