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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Patient Participation/engagement [Срок оценки: throughout study completion - an average of 2 weeks]
• Objective Engagement rating. [Срок оценки: throughout study completion - an average of 2 weeks]

Вторичные конечные точки (5)

• Patient-reported mood [Срок оценки: throughout study completion - an average of 2 weeks]
• Objective mood assessment [Срок оценки: throughout study completion - an average of 2 weeks]
• Automated mood assessment [Срок оценки: throughout study completion - an average of 2 weeks]
• Physiological distress [Срок оценки: throughout study completion - an average of 2 weeks]
• Salivary Oxytocin [Срок оценки: throughout study completion - an average of 2 weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cincinnati Children's Hospital Medical Center — Cincinnati

Идентификаторы

NCT: NCT05250180 · Cin AAT for ABI · 1R01HD106416

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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