Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oxytocin Pathways and the Health Effects of Human-Animal Interaction

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: NCT03852264
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : July 7, 2021
Sponsor:
Collaborator:
University of Virginia
Information provided by (Responsible Party):
University of Arizona

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:
This study investigates the roles of oxytocin and vasopressin in human-animal interaction. Children will participate in three conditions involving friendly interactions with dogs, or play with toys at a university laboratory.

Condition or disease Intervention/treatment Phase
HAI Behavioral: Pet dog Behavioral: Unfamiliar dog Behavioral: Nonsocial control Not Applicable

Detailed Description:
Oxytocin (OT) and arginine vasopressin (AVP) are neuropeptides that play critical roles in social behavior, cognition, stress physiology, and physical health. OT is released in adult humans and dogs during affiliative forms of human-animal interaction (HAI), and HAI attenuates AVP release in dogs. Thus, HAI may provide a safe and effective approach for stimulating endogenous OT release, and inhibiting endogenous AVP activity. The investigators will recruit a sample of typically developing 8-10 year old children who will engage in structured HAI sessions with a familiar companion dog or unfamiliar dog, compared to a nonsocial control condition.
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 : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Within-subjects, 3 conditions, order counterbalanced across participants
Masking: Single (Outcomes Assessor)
Masking Description: Personnel analyzing hormones will be blinded to the experimental condition samples were collected from.
Primary Purpose: Basic Science
Official Title: Oxytocin Pathways and the Health Effects of Human-Animal Interaction
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : July 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Oxytocin

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

Intervention Details:
  • Behavioral: Pet dog
    Children will interact freely with their pet dog for 25 minutes.
  • Behavioral: Unfamiliar dog
    Children will interact freely with an unfamiliar dog for 25 minutes
  • Behavioral: Nonsocial control
    Children will play with age-appropriate toys/games for 25 minutes.

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. Concentration of salivary oxytocin (pg/mL) [ Time Frame: 15 minutes ]
    Concentration of salivary oxytocin measured by immunoassay (pg/mL)

  2. Concentration of salivary vasopressin (pg/mL) [ Time Frame: 15 minutes ]
    Concentration of salivary vasopressin measured by immunoassay (pg/mL)

  3. Concentration of urinary oxytocin (pg/mL) [ Time Frame: 50 minutes ]
    Concentration of urinary oxytocin measured by immunoassay (pg/mL)

  4. Concentration of urinary vasopressin (pg/mL) [ Time Frame: 50 minutes ]
    Concentration of urinary vasopressin measured by immunoassay (pg/mL)

  5. Concentration of salivary cortisol (ug/dL) [ Time Frame: 50 minutes ]
    Concentration of salivary cortisol measured by immunoassay (ug/dL)


Secondary Outcome Measures :
  1. Principal component score reflecting positive affect [ Time Frame: 30 minutes ]
    Principal component score from frequency and duration of positive affect indicators (smiling, laughing) coded by ethogram. Frequency and duration of smiling and laughing will be combined to report positive affect in an aggregate principal component score.

  2. Principal component score reflecting affiliative social behavior [ Time Frame: 30 minutes ]
    Principal component score from frequency and duration of affiliative behaviors (physical contact, eye gaze, dog-directed speech) coded by ethogram. Frequency and duration of physical contact, eye gaze, and dog-directed speech will be combined to report affiliative behavior in an aggregate principal component score.


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 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants in this study will include typically-developing children between 8-10 years. Enrollment will be limited to individuals who self-identify as white and not Hispanic or Latino for reasons related to the epigenetic analyses

Exclusion Criteria:

  • known medical diseases or injuries involving the central nervous or endocrine systems, major physical abnormalities, seizures, and significant sensory, cognitive, or motor impairments
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): NCT03852264


Locations
Layout table for location information
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85721
Contact: Elizabeth Carranza    520-621-2646    ecarranza@arizona.edu   
Contact: Evan MacLean    520-621-0386    evanmaclean@email.arizona.edu   
Principal Investigator: Evan L MacLean, PhD         
Principal Investigator: Stacey R Tecot, PhD         
Sponsors and Collaborators
University of Arizona
University of Virginia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03852264    
Other Study ID Numbers: 1808883345
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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 University of Arizona:
Oxytocin
Vasopressin
Cortisol
Human-animal interaction