Animal-Assisted Interactions in Children With Life-Threatening Conditions and Their Parents

Study Overview
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Brief Summary
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This study will evaluate the effects of animal-assisted interactions (AAI) on stress, anxiety, and quality of life in children with a life-threatening condition and their parents. It is anticipated to be a milestone in understanding the human-animal bond.

Detailed Description
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Objectives: Examine the feasibility of animal-assisted interactions sessions for children with a life-threatening condition and primary caregiver to: Identify and document modifications for a safe and feasible intervention, Obtain recruitment estimates and determine potential recruitment barriers Evaluate elements of implementation fidelity (design, training, delivery/receipt of Treatment, enactment) Verify safety. H1-1: Children and parents (>60%) will complete the interventions and provide positive acceptability data. H1-2: Implementation fidelity can be achieved with the proposed methodology Determine the preliminary efficacy of animal-assisted interactions sessions for: Children with a life-threatening condition (LTC) for the outcome of health-related quality of life Children with a LTC and their primary caregivers for the outcomes of stress and anxiety H2-1 Children with a life-threatening condition who receive animal-assisted interactions will experience improved health-related quality of life (HRQOL) more than patients who do not receive animal-assisted interactions. H2-2a Children with life-threatening condition who receive animal-assisted interactions will experience decreased stress and anxiety more than parents of children who do not receive animal-assisted interactions. H2-2b Primary caregivers of children with a life-threatening condition who receive animal-assisted interactions will experience decreased stress and anxiety more than parents of children who do not receive animal-assisted interactions.

Official Title
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Effects of Animal-Assisted Interactions (AAI) on Quality of Life in Children With Life-Threatening Conditions and Their Parents

Conditions
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Advanced Cancer, Relapsed Cancer, Refractory Cancer

Intervention / Treatment
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* Behavioral: Animal-Assisted Interactions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 3-17 years old Confirmed diagnosis of relapsed or refractory cancer Exclusion Criteria: Reported fear or anxiety of dogs (child or parent)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Animal-Assisted Interactions<br>Children and their caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital. | Behavioral: Animal-Assisted Interactions<br>* Child and caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital.<br>* Other names: AAI;|
| Active Comparator: Usual Care<br>Children and their caregivers randomly assigned to the usual care group will receive usual care which may include play therapy, music therapy or visits with a social worker during their visits to the hospital. | Behavioral: Animal-Assisted Interactions<br>* Child and caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital.<br>* Other names: AAI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Quality of Life | The Peds Quality of Life measure will be administered to children and their parents (proxy) once a month | up to 3 months | 
| Anxiety | The state-trait anxiety inventory will be administered to children and their parents after each intervention or usual care visit | up to 3 months | 
| Stress | Saliva samples to measure cortisol levels will be administered to children after animal-assisted interventions or after completion of measures in usual care group | up to 3 months |