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

NCT ID: NCT05250180

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-22

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Brain Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

animal assisted therapy

Group Type EXPERIMENTAL

Animal Assisted Therapy

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

treatment as usual as dictated by their treatment team

Interventions

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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.

Intervention Type OTHER

Control

treatment as usual as dictated by their treatment team

Intervention Type OTHER

Other Intervention Names

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AAT Treatment as usual

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Miami University

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Megan Narad, PhD

Role: CONTACT

15138038902

Facility Contacts

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Megan Narad, PhD

Role: primary

513-803-8902

Other Identifiers

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1R01HD106416

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Cin AAT for ABI

Identifier Type: -

Identifier Source: org_study_id

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