The Role of Therapy Dogs in Reducing Depression, Anxiety, and Loneliness Among Hospitalized Children

NCT05551156 | Completed

• 1 other identifier: HM20023539
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to test whether an animal-assisted intervention (AAI) is better than conversation with another person or treatment as usual for improving mood, anxiety, loneliness, quality of life, and indicators of health care services such as number of hospitalizations, length of hospital stay, and cost of services for children and adolescents.

Conditions

Hospitalized Children

Outcome Measures

Primary Outcomes (4)

• Change in Depression

  Depressive symptomology will be measured with the 13-item Mood and Feelings Questionnaire (MFQ) which are rated on a 3 point scale. Higher scores indicate greater depression.

  Baseline to end of treatment (about 5 days), 1 month after treatment

• Change in Anxiety

  Anxiety will be measured using the 6-item state scale of the State-Trait Anxiety Inventory for Children (STAI-C) which are rated on a 3 point scale. Higher scores indicate more anxiety.

  Baseline to end of treatment (about 5 days), 1 month after treatment

• Change in Mood

  Mood will be measured using the Smiley Face Assessment Scale in which participants select which face fits their current mood. The scale depicts five emoticons from very sad to very happy.

  Baseline to end of treatment (about 5 days), 1 month after treatment

• Change in Loneliness

  Child loneliness will be assessed using the 11-item version of the De Jong Gierveld Loneliness Scale for children which are answered on a 5 point scale. Higher scores indicate greater loneliness.

  Baseline to end of treatment (about 5 days), 1 month after treatment

Study Arms (3)

Animal-assisted interaction

EXPERIMENTAL

A dog-handler team will visit participants in their hospital room

Behavioral: Animal-assisted interaction

Conversational interaction

EXPERIMENTAL

Conversational interaction with the participants and the dog-handler

Behavioral: Conversational interaction

Treatment as usual

NO INTERVENTION

Participants will received the regular services currently being received in the hospital

Interventions

Animal-assisted interaction BEHAVIORAL

Visits will occur on 3 consecutive days during your participant's inpatient hospital stay. A dog-handler team or a handler alone will visit participants with a dog for approximately 20 minutes at a convenient time for the participant. During this visit, the participant will be able to pet the dog if they wish. The handler will talk with the participants about the dog, the weather, sports, or other light topics. Participants can also suggest light topics to talk about as well.

Animal-assisted interaction

Conversational interaction BEHAVIORAL

Visits will occur on 3 consecutive days during your participant's inpatient hospital stay. A dog-handler team or a handler alone will visit participants without a dog for approximately 20 minutes at a convenient time for the participant. During this visit, the handler will talk with the participants about the weather, sports, or other light topics. Participants can also suggest light topics to talk about as well.

Conversational interaction

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Projected to be admitted to the hospital for the upcoming five days
• between 8-17 years of age
• speak English
• be able to provide assent (understand what the study is about and what activities are involved)
• Age 18+
• English-speaking
• Access to working phone, email, or address so that follow-up measures can be completed/sent.

You may not qualify if:

• Fear of or allergy to dogs
• documented contact precautions
• cognitive impairment that prevents consent/assent or completion of measures
• inability to participate in the study in the clinical judgment of their healthcare provider.
• Inability to understand documents written in English
• Fear of or allergy to dogs

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Purina Mills, Inc: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (8)

• Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.

  PMID: 20668659 BACKGROUND

• Administration HRaS. The Loneliness Epidemic. https://www.hrsa.gov/enews/past-issues/2019/january-17/loneliness-epidemic. Published 2019. Accessed January 23, 2021.

  BACKGROUND

• Dell NA, Pelham M, Murphy AM. Loneliness and depressive symptoms in middle aged and older adults experiencing serious mental illness. Psychiatr Rehabil J. 2019 Jun;42(2):113-120. doi: 10.1037/prj0000347. Epub 2019 Jan 21.

  PMID: 30667243 BACKGROUND

• Meltzer H, Bebbington P, Dennis MS, Jenkins R, McManus S, Brugha TS. Feelings of loneliness among adults with mental disorder. Soc Psychiatry Psychiatr Epidemiol. 2013 Jan;48(1):5-13. doi: 10.1007/s00127-012-0515-8. Epub 2012 May 9.

  PMID: 22570258 BACKGROUND

• Wells DL. The state of research on human-animal relations: implications for human health. Anthrozoös. 2019;32(2):169-181.

  BACKGROUND

• Krause-Parello CA, Gulick, E.E., Basin, B. Loneliness, depression, and physical activity in older adults: The therapeutic role of human-animal interactions. Anthrozoös. 2019;32(2):239-254.

  BACKGROUND

• Barker SB, Dawson KS. The effects of animal-assisted therapy on anxiety ratings of hospitalized psychiatric patients. Psychiatr Serv. 1998 Jun;49(6):797-801. doi: 10.1176/ps.49.6.797.

  PMID: 9634160 BACKGROUND

• Barker SB, Pandurangi AK, Best AM. Effects of animal-assisted therapy on patients' anxiety, fear, and depression before ECT. J ECT. 2003 Mar;19(1):38-44. doi: 10.1097/00124509-200303000-00008.

  PMID: 12621276 BACKGROUND

Study Officials

• Nancy R Gee, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: June 30, 2023
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)