Human-Animal BondNCT03852264
Oxytocin Pathways and the Health Effects of Human-Animal Interaction
A study testing Pet dog and Unfamiliar dog in people with Human-Animal Bond and Human-Animal Interaction, run by University of Arizona at 1 site in United States.
Trial summary
This study investigates the roles of oxytocin pathways in human-animal interaction. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Human-Animal Bond, Human-Animal Interaction
- What is being tested?
- Pet dog and Unfamiliar dog
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2019to 10 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants in this study will include typically-developing children between 8-10 years who have lived with a companion dog in the household for at least 6 months.
Who cannot join
- known medical diseases or injuries involving the central nervous or endocrine systems, major physical abnormalities, seizures, and significant sensory, cognitive, or motor impairments, current use of psychoactive medications
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the roles of oxytocin pathways in human-animal interaction.
Read the detailed description
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.
- Conditions
- Human-Animal Bond, Human-Animal Interaction
- Being tested
- Pet dog, Unfamiliar dog, Nonsocial control
- Keywords
- Oxytocin, Cortisol, Human-animal interaction
- Medical subject headings
- Human-Animal Bond, Human-Animal Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pet dogBehavioural
Children will interact freely with their pet dog for 25 minutes.
Unfamiliar dogBehavioural
Children will interact freely with an unfamiliar dog for 25 minutes
Nonsocial controlBehavioural
Children will play with age-appropriate toys/games for 25 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pet dog; Behavioral: Unfamiliar dog; Behavioral: Nonsocial control |
| 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. Receives: Behavioral: Pet dog; Behavioral: Unfamiliar dog; Behavioral: Nonsocial control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Oxytocin, Area Under the Curve
Change from baseline measured as the area under the curve with respect to the initial value (AUCi).
Measured: 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).
Measured: baseline, 50 minutes
Secondary outcomes (2)
Salivary Cortisol, Area Under the Curve
Change from baseline measured as the area under the curve with respect to the initial value (AUCi).
Measured: baseline, 50 minutes
Urinary Vasopressin, Area Under the Curve
Change from baseline measured as the area under the curve with respect to the initial value (AUCi).
Measured: baseline, 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start8 Mar 2019
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human-Animal BondStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Within-subjects, 3 conditions, 2 condition orders balanced across participants
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852264
- Sponsor's protocol ID
- 1808883345
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2019
- Last updated
- 12 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Pathways and the Health Effects of Human-Animal Interaction
- ClinicalTrials.gov ID
- NCT03852264
- Acronym / sponsor ID
- 1808883345
- Conditions
- Human-Animal Bond, Human-Animal Interaction
- Keywords
- Oxytocin, Cortisol, Human-animal interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- University of Virginia
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Posted 12 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the roles of oxytocin pathways in human-animal interaction.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Within-subjects, 3 conditions, 2 condition orders balanced across participants
| Arm | Type | Receives |
|---|---|---|
| Pet Dog Interaction first, then Nonsocial Control, then Unfamiliar Dog Interaction | Experimental | Behavioral: Pet dog, Behavioral: Unfamiliar dog, Behavioral: Nonsocial controlParticipant'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 | Behavioral: Pet dog, Behavioral: Unfamiliar dog, Behavioral: Nonsocial controlParticipant'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. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants in this study will include typically-developing children between 8-10 years who have lived with a companion dog in the household for at least 6 months.
Key exclusion criteria (1 listed)
- known medical diseases or injuries involving the central nervous or endocrine systems, major physical abnormalities, seizures, and significant sensory, cognitive, or motor impairments, current use of psychoactive medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pet dogChildren will interact freely with their pet dog for 25 minutes. | Behavioural | Pet Dog Interaction first, then Nonsocial Control, then Unfamiliar Dog Interaction, Unfamiliar Dog Interaction first, then Nonsocial Control, then Pet Dog Interaction |
| Unfamiliar dogChildren will interact freely with an unfamiliar dog for 25 minutes | Behavioural | Pet Dog Interaction first, then Nonsocial Control, then Unfamiliar Dog Interaction, Unfamiliar Dog Interaction first, then Nonsocial Control, then Pet Dog Interaction |
| Nonsocial controlChildren will play with age-appropriate toys/games for 25 minutes. | Behavioural | Pet Dog Interaction first, then Nonsocial Control, then Unfamiliar Dog Interaction, Unfamiliar Dog Interaction first, then Nonsocial Control, then Pet Dog Interaction |
Primary outcome
Salivary Oxytocin, Area Under the Curve
Time frame: baseline, 15 minutes
Change from baseline measured as the area under the curve with respect to the initial value (AUCi).
Urinary Oxytocin, Area Under the Curve
Time frame: baseline, 50 minutes
Change from baseline measured as the area under the curve with respect to the initial value (AUCi).
2 secondary outcomes
Salivary Cortisol, Area Under the Curve
Time frame: baseline, 50 minutes
Urinary Vasopressin, Area Under the Curve
Time frame: baseline, 50 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pet dog and Unfamiliar dog in people with Human-Animal Bond and Human-Animal Interaction, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Oxytocin, Area Under the Curve (time frame: baseline, 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.