COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Therapy Dogs on Child Biology and Behavior

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949569
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kristen Jacobson, University of Chicago

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Stress Reaction Behavior, Social Behavioral: Therapy Dog Behavioral: Stuffed Toy Dog Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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 two 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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Basic Science
Official Title: A Pilot Study of the Effects of Interactions With Therapy Dogs on Child Stress Responsivity
Actual Study Start Date : June 15, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949569


Contacts
Layout table for location contacts
Contact: Kristen C Jacobson, PhD (773)834-0265 kjacobso@bsd.uchicago.edu
Contact: Lauren N Pasetes, BA (773)834-7128 lpasetes@yoda.bsd.uchicago.edu

Locations
Layout table for location information
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Lauren N Pasetes, BA    773-834-7128 ext 4-7128    lpasetes@yoda.bsd.uchicago.edu   
Contact: Rena Redic, PhD    773-834-2244 ext 4-2244    rredic@yoda.bsd.uchicago.edu   
Principal Investigator: Kristen Jacobson, PhD         
Sponsors and Collaborators
University of Chicago
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Kristen C Jacobson, PhD University of Chicago
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Kristen Jacobson, PI, Associate Professor of Psychiatry & Behavioral Neuroscience, University of Chicago
ClinicalTrials.gov Identifier: NCT03949569    
Other Study ID Numbers: IRB18-0472
R21HD094956 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD underlying research publications
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristen Jacobson, University of Chicago:
Children
Human-Animal Interaction
Stress
Cortisol
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Stress
Fractures, Bone
Wounds and Injuries