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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03852264
Other study ID # 1808883345
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 8, 2019
Est. completion date January 10, 2022

Study information

Verified date September 2022
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 10, 2022
Est. primary completion date January 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 10 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Arizona Tucson Arizona

Sponsors (2)

Lead Sponsor Collaborator
University of Arizona University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of salivary oxytocin (pg/mL) Concentration of salivary oxytocin measured by immunoassay (pg/mL) 15 minutes
Primary Concentration of salivary vasopressin (pg/mL) Concentration of salivary vasopressin measured by immunoassay (pg/mL) 15 minutes
Primary Concentration of urinary oxytocin (pg/mL) Concentration of urinary oxytocin measured by immunoassay (pg/mL) 50 minutes
Primary Concentration of urinary vasopressin (pg/mL) Concentration of urinary vasopressin measured by immunoassay (pg/mL) 50 minutes
Primary Concentration of salivary cortisol (ug/dL) Concentration of salivary cortisol measured by immunoassay (ug/dL) 50 minutes
Secondary Principal component score reflecting positive affect 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. 30 minutes
Secondary Principal component score reflecting affiliative social behavior 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. 30 minutes
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