The Effects of Therapy Dogs on Child Biology and Behavior

September 24, 2019 updated by: Kristen Jacobson, University of Chicago

A Pilot Study of the Effects of Interactions With Therapy Dogs on Child Stress Responsivity

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The central goal of the study is to determine whether brief interactions with a therapy dog have an immediate impact on children's biological response to stress, prosocial behaviors, and self-reported mood in comparison to interactions with a stuffed toy dog. The study uses a randomized crossover design with two study arms; all children will receive the both interventions during the same session, with the timing of the intervention randomized across subject. All outcomes will be assessed during a single study visit. No follow-up data will be collected.

The study uses both between-group and within-subject comparisons. Between groups, the investigators predict that children who interact with a therapy dog prior to a psychosocial stress task (Arm 1) will show attenuated cortisol response to the stress task (primary outcome) and reduced physiological stress (secondary outcomes) compared to children who interact with a stuffed toy dog prior to the psychosocial stress task (Arm 2). Conversely, children who interact with the therapy dog immediately prior to the in-lab behavior tasks (Arm 2) will show higher levels of behavioral carefulness and prosocial behavior (primary outcomes) compared to children who interact with the stuffed toy dog prior to the behavior tasks (Arm 1).

Within subjects across both study arms, increases in positive mood and decreases in negative mood (secondary outcomes) will be greatest following interaction with the therapy dog compared to the stuffed toy dog, after controlling for main effects of study arm. Within subjects, physiological markers of stress (secondary outcomes) will be lower during the interaction with the therapy dog than during interaction with the stuffed toy dog.

Investigators will seek additional funds to collect and analyze salivary oxytocin data. The hypothesis is that children will show greater increase in oxytocin following interaction with the therapy dog in comparison to interaction with the stuffed toy dog.

This study will also investigate the mechanisms through which child-dog interactions influence youth stress responsivity, using coded videotaped data from the subset of children in Arm 1 who interact with the therapy dog prior to the psychosocial stress task. It is hypothesized that child behaviors observed during the interaction, such as duration and frequency of eye gaze, petting and stroking behaviors, and use of positive affect, will be inversely correlated with change in cortisol response to stress. Dog behaviors, such as duration and frequency of eye gaze and approach behaviors, will be inversely correlated with children's change in cortisol response to stress.

The study will also investigate whether child characteristics moderate the effects of the child-dog interaction. Investigators hypothesize that the effects of the therapy dog intervention will be stronger among children who currently live with dogs versus non-dog owning children and among children with more positive attitudes towards pets. It is also expected that the effects of the therapy dog interaction will be weaker among children with internalizing problems and for children experiencing higher levels of general stress. Investigators will also test whether the effects of the therapy dog intervention vary across child gender, race/ethnicity, or socioeconomic status, or child personality.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kristen Jacobson, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Children between the ages of 8-12 years old

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
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
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.
Behavioral: Stuffed Toy Dog
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.
Experimental: Arm 2
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
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.
Behavioral: Stuffed Toy Dog
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean level and Change in Salivary cortisol
Time Frame: Measured at baseline and over a 45 minute period before and after the psychosocial stress test
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
Time Frame: Assessed after the 2nd intervention.
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
Time Frame: Assessed after the 2nd intervention.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean level and Change in Psychological Well Being assessed by the Positive and Negative Affect Scale for Children (PANAS-C)
Time Frame: Measured at the beginning of the study visit and before and after each intervention.
The PANAS-C will be administered repeatedly during the study visit.
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
Time Frame: Assessed during both interventions and during the psychosocial stress test.
Participants will wear an E4 wristband during the study visit that records continuous physiological markers of stress.
Assessed during both interventions and during the psychosocial stress test.
Mean level and Change in heart rate measured with the E4 wristband
Time Frame: Assessed during both interventions and during the psychosocial stress test.
Participants will wear an E4 wristband during the study visit that records continuous physiological markers of stress.
Assessed during both interventions and during the psychosocial stress test.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Level and Change in Salivary Oxytocin (pending additional funds)
Time Frame: Assessed immediately before and after each intervention.
Salivary oxytocin will be measured repeatedly during the study visit.
Assessed immediately before and after each intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

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

Investigators

  • Principal Investigator: Kristen C Jacobson, PhD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2019

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

April 30, 2021

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

May 10, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB18-0472
  • R21HD094956 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD underlying research publications

IPD Sharing Time Frame

Data will be available beginning 6 months after publication and will be available for up to 5 years post-publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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