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Completed

NCT Number: NCT04310345

Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents

This study will evaluate the effects of human-animal interaction on reducing anxiety, depression, worry, and pain and enhancing quality of life in children ages 6-17 years old with a life threatening cancer and their parent caregivers.

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

About this study

Objectives:

  • To examine the feasibility of human-animal interaction (HAI) sessions for children with a life threatening cancer and a primary caregiver, specifically to:
  • To identify and document necessary modifications for a safe and feasible intervention
  • To obtain recruitment estimates and determine potential recruitment barriers
  • To evaluate elements of implementation fidelity (design, training, delivery/receipt of treatment, enactment)
  • To verify safety
  • To determine the preliminary efficacy of human-animal interaction sessions:
  • On children with a life threatening cancer for the outcomes of qualify of life, anxiety, depression, worry, and pain
  • On caregivers of children with a life threatening cancer for the outcomes of stress and anxiety

Exploratory Objective:

  • To explore mechanisms (reduced salivary cortisol and urinary norepinephrine levels) associated with 8 weeks of human-animal interaction.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Child:

  • Children age 6-17 years old that have been diagnosed with advanced cancer as defined by any stage of relapsed, recurrent or refractory cancer
  • Able to understand English or Spanish to complete consents and surveys

Parent or Guardian:

  • Parent or guardian as determined by person who brings child to >50% of their clinic visits
  • Able to understand English or Spanish to complete consents and surveys

Exclusion criteria

for both Children and Parent/Guardian:

  • Self-reported fear of or allergies to canines
  • Cognitive impairment as identified by healthcare team or inability to complete consenting process

Treatment and study plan

Animal-Assisted Interactions

Behavioral

Child and caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.

Primary outcomes

  1. Pediatric Quality of Life

    Time frame: Up to 2 months

    The Pediatric Quality of Life Inventory (PedsQL) was administered to children and their parents (proxy for child quality of life) at baseline, week 4, and week 8 visits. Weeks 4 and 8 were after interacting with a therapy dog. Baseline surveys collected without seeing a therapy dog. The PedsQL Measurement is a validated scale to assess health-related quality of life in children and adolescents with acute and chronic health conditions. Scores are scaled from 1-100, with higher scores indicative of better quality of life.

  2. Anxiety

    Time frame: Up to 2 months

    The state-trait anxiety inventory State sub scale was administered to children (STAI-Child) and their parents (STAI) at baseline, week 4, and week 8. The 20-item STAI-CH is a validated scale for anxiety in children aged 5-17; the 20-item STAI is validated to assess anxiety in adult participants. The State subscale is intended to assess level of anxiety at the time of survey administration. Possible range of scores of the STAI-CH State subscale is 20-60, while the possible range from the STAI state subscale for adults is 20-80. Higher scores are indicative of increased anxiety. Baseline data were obtained without seeing a therapy dog, whereas STAI-CH and STAI surveys were conducted after seeing the therapy dog at weeks 4 and 8.

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

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

Registry information

Official study title

Exploring the Impact of Human-Animal Interactions on Children With Life-Threatening Conditions and Their Parents

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 17, 2020
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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