Actively Recruiting

Phase Not Applicable
Age: 4Years - 24Years
All Genders
ID05250180

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

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-05-08

90

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

E

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying children and adolescents aged 4 to 21 who are undergoing inpatient rehabilitation after an acquired brain injury (ABI), such as traumatic brain injury, brain tumor, or infection. The study aims to find out whether involving dogs in physical and occupational therapy sessions improves patient engagement during rehabilitation. The project also seeks to understand how dog involvement affects engagement and to identify which patients might benefit the most from this approach. Participants will be randomly assigned to have dog-assisted therapy incorporated into their physical and occupational therapy sessions on two days during their stay—once in the first week and once in the second week. The dog will be integrated into therapy based on each patient's functioning level and therapy goals. The other group will receive usual treatment as determined by their care team without dog involvement. This crossover design allows comparison between therapy with and without dogs. During the approximately two-week study period, researchers will closely observe and rate patient participation and engagement in therapy sessions. They will also assess mood through patient reports, objective and automated measures, physiological distress, and salivary oxytocin levels. These measures will help understand the effects of dog-assisted therapy. The study involves informed consent from families and assent from participants, with careful monitoring throughout the rehabilitation stay.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 4Years - 24Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be admitted to inpatient rehabilitation for acquired brain injury such as TBI, brain tumor, or infection
  • Age between 4 and 21 years at screening
  • Both males and females are eligible
  • Family must provide informed consent
  • Child or adolescent must provide assent by signature
  • Rancho score greater than 2 at enrollment
Not Eligible

You will not qualify if you...

  • Significant allergy to dogs
  • Significant fear of dogs
  • On contact precautions or have a communicable disease posing risk to dog or handler
  • Compromised immune system where dog interaction poses significant risk
  • History of developmental delay before acquired brain injury
  • Participant or family history of animal abuse or cruelty
  • Rancho score of 2 or less

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 2 weeks

Participants receive inpatient rehabilitation therapy sessions with and without animal assisted therapy integrated into their physical and occupational therapy sessions on two days during their stay.

Therapy sessions on 2 days with animal assisted therapy integrated, plus usual therapy sessions as scheduled

Trial Site Locations

Total: 1 location

1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

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Research Team

M

Megan Narad, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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