The Effects of Therapy Dogs on Child Biology and Behavior

NCT03949569 | Completed

• 2 other identifiers: IRB18-0472R21HD094956
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to apply a rigorous experimental design to test whether children's interactions with therapy dogs increase immediate prosocial behavior and reduce immediate biological response to stress.

Conditions

Stress Reaction; Behavior, Social

Keywords

Children; Human-Animal Interaction; Stress; Cortisol

Outcome Measures

Primary Outcomes (3)

• Mean level and Change in Salivary cortisol

  Salivary cortisol will be collected 7 times during the study visit.

  Measured at baseline and over a 45 minute period before and after the psychosocial stress test

• Mean level Prosocial behavior assessed with the Zurich prosocial game

  During the study visit prosocial behavior is assessed through total number of helping behaviors recorded during the Zurich prosocial game.

  Assessed after the 2nd intervention.

• Mean level Behavioral carefulness assessed with the children's game, Operation

  During the study visit, participants will play the game Operation. Behavioral carefulness metrics include number of errors and total time to complete the task.

  Assessed after the 2nd intervention.

Secondary Outcomes (3)

• Mean level and Change in Psychological Well Being assessed by the Positive and Negative Affect Scale for Children (PANAS-C)

  Measured at the beginning of the study visit and before and after each intervention.

• Mean level and Change in galvanic skin response measured with the E4 wristband

  Assessed during both interventions and during the psychosocial stress test.

• Mean level and Change in heart rate measured with the E4 wristband

  Assessed during both interventions and during the psychosocial stress test.

Other Outcomes (1)

• Mean Level and Change in Salivary Oxytocin (pending additional funds)

  Assessed immediately before and after each intervention.

Study Arms (3)

Arm 1

EXPERIMENTAL

In this condition, children will interact with the therapy dog prior to the psychosocial stress task and with the stuffed toy dog prior to the prosocial behavior tests.

Behavioral: Therapy Dog; Behavioral: Stuffed Toy Dog

Arm 2

EXPERIMENTAL

In this condition, children will interact with the stuffed toy prior to the psychosocial stress task collection and with the therapy dog prior to the prosocial behavior tests.

Behavioral: Therapy Dog; Behavioral: Stuffed Toy Dog

Arm 3

EXPERIMENTAL

In this condition, children will watch a 5 minute puppy video prior to the psychosocial stress task collection and with the therapy dog prior to the prosocial behavior tests.

Behavioral: Stuffed Toy Dog; Behavioral: 5 Minute Puppy Video

Interventions

Therapy Dog BEHAVIORAL

Children will undergo a 5 minute unstructured session with either a certified therapy dog or with a dog who is trained and certified for animal-assisted interventions and/or animal-assisted activities. Children will be allowed to talk to, pet, and play with the therapy dog during the interaction.

Arm 1; Arm 2

Stuffed Toy Dog BEHAVIORAL

Children will undergo a 5 minute unstructured session with a stuffed toy dog. Children will be allowed to talk to, pet, and play with the stuffed toy dog during the interaction.

Arm 1; Arm 2; Arm 3

5 Minute Puppy Video BEHAVIORAL

Children will watch a 5 minute puppy video.

Arm 3

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Children between the ages of 8-12 years old

You may not qualify if:

• Limited comprehension of English
• Severe neurological, medical, or psychiatric illnesses (e.g., schizophrenia, psychosis)
• Severe asthma or animal allergies
• Animal phobias
• Use of medications that affect cortisol

Sponsors & Collaborators

• University of Chicago: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

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MeSH Terms

Conditions

Fractures, Stress; Social Behavior; Human-Animal Interaction

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Behavior

Study Officials

• Kristen C Jacobson, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will be unaware of which study arm they are assigned. Individuals performing the interventions will be blind to study condition. The investigator will be blind to study condition until data analysis. Video data will be coded by observers blind to the study condition. The primary outcomes assessor is not blind to study condition.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will use a randomized crossover design. All children will receive two interventions during a single study visit. Children will be assigned to one of three research design arms using a stratified random sampling approach with child sex balanced across arm (N=110 in each group). All children will participate in the same tasks, in the same order. The only difference between research design arms is the timing of the interventions. In one arm the child will interact with the therapy dog prior to the psychosocial stress test and will interact with the stuffed toy dog prior to the behavioral tasks; the reverse is true for children in the second arm. In the third arm, the child will watch a 5 minute puppy video prior to the psychosocial stress test and will interact with the stuffed toy dog prior to the behavioral tasks

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: May 14, 2019
• Study Start: June 15, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication and will be available for up to 5 years post-publication.
• Access Criteria: The PI will evaluate written requests for IPD sharing. All requests must be made from individuals with legitimate research questions and must be compliant with IRB regulations.

Locations

US (1)