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

Vanderbilt University Medical Center

Status: Completed

Conditions: Advanced Cancer; Relapsed Cancer; Refractory Cancer

Treatments: Behavioral: Animal-Assisted Interactions

Study type: Interventional

Funder types: Other

Identifiers

NCT03765099

VICC PED 18166

Details and patient eligibility

About

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.

Full description

Objectives:

1. 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

2. 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.

Enrollment: 70 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Animal-Assisted Interactions

Experimental group

Description:

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.

Treatment:

Behavioral: Animal-Assisted Interactions

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Animal-Assisted Interactions