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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765099
• Other study ID #: VICC PED 18166
• Status: Completed
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Advanced Cancer
• Refractory Cancer
• Relapsed Cancer

Intervention

Behavioral:
• Animal-Assisted Interactions
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.

Locations

Country	Name	City	State
United States	Monroe Carell Jr Children's Hospital at Vanderbilt	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	Human Animal Bond Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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