Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Virginia | OTHER |
Not provided
Not provided
Not provided
Not provided
This study investigates the roles of oxytocin pathways in human-animal interaction.
This study investigates the roles of oxytocin pathways in human-animal interaction. Children will participate in three conditions involving friendly interactions with dogs, or play with toys at a university laboratory. Child and dog saliva and urine will be assayed for oxytocin concentrations. We will assess variation in oxytocin concentrations in relation to different experimental conditions, and in relation to specific behaviors and psychological constructs.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pet Dog Interaction first, then Nonsocial Control, then Unfamiliar Dog Interaction | Experimental | Participant's first study visit involved 25 minutes of interaction with the participant's pet dog. The second study visit involved 25 minutes of individual play with toys. The third study visit involved 25 minutes of interaction with an unfamiliar dog. |
|
| Unfamiliar Dog Interaction first, then Nonsocial Control, then Pet Dog Interaction | Experimental | Participant's first study visit involved 25 minutes of interaction with an unfamiliar dog. The second study visit involved 25 minutes of individual play with toys. The third study visit involved 25 minutes of interaction with the participant's pet dog. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pet dog | Behavioral | Children will interact freely with their pet dog for 25 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Oxytocin, Area Under the Curve | Change from baseline measured as the area under the curve with respect to the initial value (AUCi). | baseline, 15 minutes |
| Urinary Oxytocin, Area Under the Curve | Change from baseline measured as the area under the curve with respect to the initial value (AUCi). | baseline, 50 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Cortisol, Area Under the Curve | Change from baseline measured as the area under the curve with respect to the initial value (AUCi). | baseline, 50 minutes |
| Urinary Vasopressin, Area Under the Curve |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85721 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
None / not applicable
Participants were recruited from the local community through email listservs, print advertisements, social media, and flyers distributed to schools, libraries, museums, and veterinary clinics. Recruitment occurred between February 1, 2019 and February 1, 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pet Dog Interaction First, Then Nonsocial Control, Then Unfamiliar Dog Interaction | Participant's first study visit involved 25 minutes of interaction with the participant's pet dog. The second study visit involved 25 minutes of individual play with toys. The third study visit involved 25 minutes of interaction with an unfamiliar dog. |
| FG001 | Unfamiliar Dog Interaction First, Then Nonsocial Control, Then Pet Dog Interaction | Participant's first study visit involved 25 minutes of interaction with an unfamiliar dog. The second study visit involved 25 minutes of individual play with toys. The third study visit involved 25 minutes of interaction with the participant's pet dog. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Research Visit |
| |||||||||||||
| Second Research Visit |
| |||||||||||||
| Third Research Visit |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pet Dog Interaction First, Then Nonsocial Control, Then Unfamiliar Dog Interaction | Participant's first study visit involved 25 minutes of interaction with the participant's pet dog. The second study visit involved 25 minutes of individual play with toys. The third study visit involved 25 minutes of interaction with an unfamiliar dog. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Salivary Oxytocin, Area Under the Curve | Change from baseline measured as the area under the curve with respect to the initial value (AUCi). | All study participants for whom saliva samples were available for analysis | Posted | Mean | Standard Error | pg/mL x minutes | baseline, 15 minutes |
|
1 hour
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pet Dog Interaction | Participants interacted with their pet dog for 25 minutes |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Evan MacLean | University of Arizona | 520-621-0386 | evanmaclean@arizona.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2024 | Mar 15, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 22, 2018 | Dec 27, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001841 | Human-Animal Bond |
| D000081762 | Human-Animal Interaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Within-subjects, 3 conditions, 2 condition orders balanced across participants
Not provided
Not provided
Personnel analyzing hormones will be blinded to the experimental condition samples were collected from.
| Unfamiliar dog | Behavioral | Children will interact freely with an unfamiliar dog for 25 minutes |
|
| Nonsocial control | Behavioral | Children will play with age-appropriate toys/games for 25 minutes. |
|
Change from baseline measured as the area under the curve with respect to the initial value (AUCi).
| baseline, 50 minutes |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 |
| Unfamiliar Dog Interaction First, Then Nonsocial Control, Then Pet Dog Interaction |
Participant's first study visit involved 25 minutes of interaction with an unfamiliar dog. The second study visit involved 25 minutes of individual play with toys. The third study visit involved 25 minutes of interaction with the participant's pet dog. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants interacted with an assortment of toys |
|
|
|
| Primary | Urinary Oxytocin, Area Under the Curve | Change from baseline measured as the area under the curve with respect to the initial value (AUCi). | All children with urine samples available for analysis | Posted | Mean | Standard Error | pg/ml x minutes | baseline, 50 minutes |
|
|
|
|
| Secondary | Salivary Cortisol, Area Under the Curve | Change from baseline measured as the area under the curve with respect to the initial value (AUCi). | All participants with saliva samples available for analysis | Posted | Mean | Standard Error | pg/mL x minutes | baseline, 50 minutes |
|
|
|
|
| Secondary | Urinary Vasopressin, Area Under the Curve | Change from baseline measured as the area under the curve with respect to the initial value (AUCi). | unable to complete assay for this outcome | Posted | baseline, 50 minutes |
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Unfamiliar Dog Interaction | Participants interacted with an unfamiliar dog for 25 minutes | 0 | 54 | 0 | 54 | 0 | 54 |
| EG002 | Toys Interaction | Participants interacted with an assortment of toys for 25 minutes | 0 | 55 | 0 | 55 | 0 | 55 |
Not provided
Not provided
|
Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition. |
| Mean Difference (Net) |
| -0.0635 |
| 2-Sided |
| 90 |
| -0.931 |
| 0.803 |
Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction |
| Other |
90% credible interval for contrast between conditions |
| Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition. | Mean Difference (Net) | -0.4220 | 2-Sided | 90 | -1.319 | 0.445 | Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction | Other | 90% credible interval for contrast between conditions |
Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition. |
| Mean Difference (Net) |
| -115 |
| 2-Sided |
| 90 |
| -225 |
| -15.5 |
Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction |
| Other |
90% credible interval for contrast between conditions |
| Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition. | Mean Difference (Net) | -115.48 | 2-Sided | 90 | -223 | -16.2 | Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction | Other | 90% credible interval for contrast between conditions |