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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-24
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Animal Assisted Therapy

    Other intervention

    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

    Other intervention

    treatment as usual as dictated by their treatment team

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
throughout study completion - an average of 2 weeks
2

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.

Time frame
throughout study completion - an average of 2 weeks

Secondary outcomes

1

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.

Time frame
throughout study completion - an average of 2 weeks
2

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.

Time frame
throughout study completion - an average of 2 weeks
3

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.

Time frame
throughout study completion - an average of 2 weeks
4

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.

Time frame
throughout study completion - an average of 2 weeks

Other outcomes

1

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.

Time frame
throughout study completion - an average of 2 weeks
2

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.

Time frame
throughout study completion - an average of 2 weeks

Sponsors and contacts

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Children's Hospital Medical Center, Cincinnati

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Miami University

Collaborator

Ohio State University

Collaborator