Animal Assisted Therapy After Pediatric Brain Injury: Mediators and Moderators of Treatment Response.
- Conditions
- Brain Injuries
- Interventions
- Other: Animal Assisted TherapyOther: Control
- Registration Number
- NCT05250180
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention Animal Assisted Therapy animal assisted therapy Control Control Treatment as usual
- Primary Outcome Measures
Name Time Method Patient Participation/engagement throughout study completion - an average of 2 weeks 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. throughout study completion - an average of 2 weeks 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
Name Time Method Patient-reported mood throughout study completion - an average of 2 weeks 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.
Automated mood assessment throughout study completion - an average of 2 weeks 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.
Objective mood assessment throughout study completion - an average of 2 weeks 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.
Physiological distress throughout study completion - an average of 2 weeks 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 throughout study completion - an average of 2 weeks Level of oxytocin present in patient's saliva
Trial Locations
- Locations (1)
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States