Stress ReactionNCT03949569
The Effects of Therapy Dogs on Child Biology and Behavior
A study testing Therapy Dog, Stuffed Toy Dog and 5 Minute Puppy Video in people with Stress Reaction and Behavior, Social, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Reaction, Behavior, Social
- What is being tested?
- Therapy Dog, Stuffed Toy Dog and 5 Minute Puppy Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2019to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of 8-12 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: A Pilot Study of the Effects of Interactions With Therapy Dogs on Child Stress Responsivity
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.
Read the 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). As an additional control, children will also watch a 5 minute puppy video prior to the prosocial stress task and will then interact with a stuffed toy dog prior to the psychosocial stress task (Arm 3).
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.
- Conditions
- Stress Reaction, Behavior, Social
- Being tested
- Therapy Dog, Stuffed Toy Dog, 5 Minute Puppy Video
- Keywords
- Children, Human-Animal Interaction, Stress, Cortisol
- Medical subject headings
- Fractures, Stress, Social Behavior, Human-Animal Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy DogBehavioural
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.
Stuffed Toy DogBehavioural
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.
5 Minute Puppy VideoBehavioural
Children will watch a 5 minute puppy video.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 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. Receives: Behavioral: Therapy Dog; Behavioral: Stuffed Toy Dog |
| Arm 2 | Experimental | 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. Receives: Behavioral: Therapy Dog; Behavioral: Stuffed Toy Dog |
| Arm 3 | Experimental | In this condition, children will watch a 5 minute puppy video prior to the psychosocial stress task collection and with the therapy dog prior to the prosocial behavior tests. Receives: Behavioral: Stuffed Toy Dog; Behavioral: 5 Minute Puppy Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean level and Change in Salivary cortisol
Salivary cortisol will be collected 7 times during the study visit.
Measured: Measured at baseline and over a 45 minute period before and after the psychosocial stress test
Mean level Prosocial behavior assessed with the Zurich prosocial game
During the study visit prosocial behavior is assessed through total number of helping behaviors recorded during the Zurich prosocial game.
Measured: Assessed after the 2nd intervention.
Mean level Behavioral carefulness assessed with the children's game, Operation
During the study visit, participants will play the game Operation. Behavioral carefulness metrics include number of errors and total time to complete the task.
Measured: Assessed after the 2nd intervention.
Secondary outcomes (3)
Mean level and Change in Psychological Well Being assessed by the Positive and Negative Affect Scale for Children (PANAS-C)
The PANAS-C will be administered repeatedly during the study visit.
Measured: Measured at the beginning of the study visit and before and after each intervention.
Mean level and Change in galvanic skin response measured with the E4 wristband
Participants will wear an E4 wristband during the study visit that records continuous physiological markers of stress.
Measured: Assessed during both interventions and during the psychosocial stress test.
Mean level and Change in heart rate measured with the E4 wristband
Participants will wear an E4 wristband during the study visit that records continuous physiological markers of stress.
Measured: Assessed during both interventions and during the psychosocial stress test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start15 Jun 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Stress ReactionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Randomised
- Intervention model
- Crossover
- 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 three 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. In the third arm, the child will watch a 5 minute puppy video prior to the psychosocial stress test and will interact with the stuffed toy dog prior to the behavioral tasks
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Kristen C Jacobson, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949569
- Sponsor's protocol ID
- IRB18-0472
- Other IDs
- R21HD094956
- Status last verified
- May 2024
- First submitted
- 5 Apr 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD underlying research publications
Publications
Merikangas KR, He JP, Brody D, Fisher PW, Bourdon K, Koretz DS. Prevalence and treatment of mental disorders among US children in the 2001-2004 NHANES. Pediatrics. 2010 Jan;125(1):75-81. doi: 10.1542/peds.2008-2598. Epub 2009 Dec 14.
PubMed 20008426Costello EJ, Egger H, Angold A. 10-year research update review: the epidemiology of child and adolescent psychiatric disorders: I. Methods and public health burden. J Am Acad Child Adolesc Psychiatry. 2005 Oct;44(10):972-86. doi: 10.1097/01.chi.0000172552.41596.6f.
PubMed 16175102Merikangas KR, He JP, Burstein M, Swanson SA, Avenevoli S, Cui L, Benjet C, Georgiades K, Swendsen J. Lifetime prevalence of mental disorders in U.S. adolescents: results from the National Comorbidity Survey Replication--Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980-9. doi: 10.1016/j.jaac.2010.05.017. Epub 2010 Jul 31.
PubMed 20855043Lewinsohn PM, Zinbarg R, Seeley JR, Lewinsohn M, Sack WH. Lifetime comorbidity among anxiety disorders and between anxiety disorders and other mental disorders in adolescents. J Anxiety Disord. 1997 Jul-Aug;11(4):377-94. doi: 10.1016/s0887-6185(97)00017-0.
PubMed 9276783Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in the United States. Int J Methods Psychiatr Res. 2012 Sep;21(3):169-84. doi: 10.1002/mpr.1359. Epub 2012 Aug 1.
PubMed 22865617Kiecolt-Glaser JK, McGuire L, Robles TF, Glaser R. Emotions, morbidity, and mortality: new perspectives from psychoneuroimmunology. Annu Rev Psychol. 2002;53:83-107. doi: 10.1146/annurev.psych.53.100901.135217.
PubMed 11752480Miller GE, Chen E, Parker KJ. Psychological stress in childhood and susceptibility to the chronic diseases of aging: moving toward a model of behavioral and biological mechanisms. Psychol Bull. 2011 Nov;137(6):959-97. doi: 10.1037/a0024768.
PubMed 21787044Adam EK, Kumari M. Assessing salivary cortisol in large-scale, epidemiological research. Psychoneuroendocrinology. 2009 Nov;34(10):1423-36. doi: 10.1016/j.psyneuen.2009.06.011. Epub 2009 Jul 31.
PubMed 19647372Sapolsky RM, Romero LM, Munck AU. How do glucocorticoids influence stress responses? Integrating permissive, suppressive, stimulatory, and preparative actions. Endocr Rev. 2000 Feb;21(1):55-89. doi: 10.1210/edrv.21.1.0389.
PubMed 10696570McEwen BS. Stress, adaptation, and disease. Allostasis and allostatic load. Ann N Y Acad Sci. 1998 May 1;840:33-44. doi: 10.1111/j.1749-6632.1998.tb09546.x.
PubMed 9629234Gunnar MR, Quevedo KM. Early care experiences and HPA axis regulation in children: a mechanism for later trauma vulnerability. Prog Brain Res. 2008;167:137-49. doi: 10.1016/S0079-6123(07)67010-1.
PubMed 18037012Miller GE, Chen E, Zhou ES. If it goes up, must it come down? Chronic stress and the hypothalamic-pituitary-adrenocortical axis in humans. Psychol Bull. 2007 Jan;133(1):25-45. doi: 10.1037/0033-2909.133.1.25.
PubMed 17201569Klein ZA, Romeo RD. Changes in hypothalamic-pituitary-adrenal stress responsiveness before and after puberty in rats. Horm Behav. 2013 Jul;64(2):357-63. doi: 10.1016/j.yhbeh.2013.01.012. Epub 2013 Mar 7.
PubMed 23465865Lightman SL. The neuroendocrinology of stress: a never ending story. J Neuroendocrinol. 2008 Jun;20(6):880-4. doi: 10.1111/j.1365-2826.2008.01711.x.
PubMed 18601712Costello EJ, He JP, Sampson NA, Kessler RC, Merikangas KR. Services for adolescents with psychiatric disorders: 12-month data from the National Comorbidity Survey-Adolescent. Psychiatr Serv. 2014 Mar 1;65(3):359-66. doi: 10.1176/appi.ps.201100518.
PubMed 24233052
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effects of Interactions With Therapy Dogs on Child Stress Responsivity
- ClinicalTrials.gov ID
- NCT03949569
- Acronym / sponsor ID
- IRB18-0472
- Conditions
- Stress Reaction, Behavior, Social
- Keywords
- Children, Human-Animal Interaction, Stress, Cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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). As an additional control, children will also watch a 5 minute puppy video prior to the prosocial stress task and will then interact with a stuffed toy dog prior to the psychosocial stress task (Arm 3).
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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 three 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. In the third arm, the child will watch a 5 minute puppy video prior to the psychosocial stress test and will interact with the stuffed toy dog prior to the behavioral tasks
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Therapy Dog, Behavioral: Stuffed Toy DogIn 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. |
| Arm 2 | Experimental | Behavioral: Therapy Dog, Behavioral: Stuffed Toy DogIn 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. |
| Arm 3 | Experimental | Behavioral: Stuffed Toy Dog, Behavioral: 5 Minute Puppy VideoIn this condition, children will watch a 5 minute puppy video prior to the psychosocial stress task collection and with the therapy dog prior to the prosocial behavior tests. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the ages of 8-12 years old
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Therapy DogChildren 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. | Behavioural | Arm 1, Arm 2 |
| Stuffed Toy DogChildren 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. | Behavioural | Arm 1, Arm 2, Arm 3 |
| 5 Minute Puppy VideoChildren will watch a 5 minute puppy video. | Behavioural | Arm 3 |
Primary outcome
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.
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.
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.
3 secondary outcomes
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.
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.
Mean level and Change in heart rate measured with the E4 wristband
Time frame: Assessed during both interventions and during the psychosocial stress test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 20008426Merikangas KR, He JP, Brody D, Fisher PW, Bourdon K, Koretz DS. Prevalence and treatment of mental disorders among US children in the 2001-2004 NHANES. Pediatrics. 2010 Jan;125(1):75-81. doi: 10.1542/peds.2008-2598. Epub 2009 Dec 14.
- Background: PubMed 16175102Costello EJ, Egger H, Angold A. 10-year research update review: the epidemiology of child and adolescent psychiatric disorders: I. Methods and public health burden. J Am Acad Child Adolesc Psychiatry. 2005 Oct;44(10):972-86. doi: 10.1097/01.chi.0000172552.41596.6f.
- Background: PubMed 20855043Merikangas KR, He JP, Burstein M, Swanson SA, Avenevoli S, Cui L, Benjet C, Georgiades K, Swendsen J. Lifetime prevalence of mental disorders in U.S. adolescents: results from the National Comorbidity Survey Replication--Adolescent Supplement (NCS-A). J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):980-9. doi: 10.1016/j.jaac.2010.05.017. Epub 2010 Jul 31.
- Background: PubMed 9276783Lewinsohn PM, Zinbarg R, Seeley JR, Lewinsohn M, Sack WH. Lifetime comorbidity among anxiety disorders and between anxiety disorders and other mental disorders in adolescents. J Anxiety Disord. 1997 Jul-Aug;11(4):377-94. doi: 10.1016/s0887-6185(97)00017-0.
- Background: PubMed 22865617Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in the United States. Int J Methods Psychiatr Res. 2012 Sep;21(3):169-84. doi: 10.1002/mpr.1359. Epub 2012 Aug 1.
- Background: PubMed 11752480Kiecolt-Glaser JK, McGuire L, Robles TF, Glaser R. Emotions, morbidity, and mortality: new perspectives from psychoneuroimmunology. Annu Rev Psychol. 2002;53:83-107. doi: 10.1146/annurev.psych.53.100901.135217.
- Background: PubMed 21787044Miller GE, Chen E, Parker KJ. Psychological stress in childhood and susceptibility to the chronic diseases of aging: moving toward a model of behavioral and biological mechanisms. Psychol Bull. 2011 Nov;137(6):959-97. doi: 10.1037/a0024768.
- Background: PubMed 19647372Adam EK, Kumari M. Assessing salivary cortisol in large-scale, epidemiological research. Psychoneuroendocrinology. 2009 Nov;34(10):1423-36. doi: 10.1016/j.psyneuen.2009.06.011. Epub 2009 Jul 31.
- Background: PubMed 10696570Sapolsky RM, Romero LM, Munck AU. How do glucocorticoids influence stress responses? Integrating permissive, suppressive, stimulatory, and preparative actions. Endocr Rev. 2000 Feb;21(1):55-89. doi: 10.1210/edrv.21.1.0389.
- Background: PubMed 9629234McEwen BS. Stress, adaptation, and disease. Allostasis and allostatic load. Ann N Y Acad Sci. 1998 May 1;840:33-44. doi: 10.1111/j.1749-6632.1998.tb09546.x.
- Background: PubMed 18037012Gunnar MR, Quevedo KM. Early care experiences and HPA axis regulation in children: a mechanism for later trauma vulnerability. Prog Brain Res. 2008;167:137-49. doi: 10.1016/S0079-6123(07)67010-1.
- Background: PubMed 17201569Miller GE, Chen E, Zhou ES. If it goes up, must it come down? Chronic stress and the hypothalamic-pituitary-adrenocortical axis in humans. Psychol Bull. 2007 Jan;133(1):25-45. doi: 10.1037/0033-2909.133.1.25.
- Individual participant dataSharing planned: Yes. All IPD underlying research publications
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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.
Kristen C Jacobson, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy Dog, Stuffed Toy Dog and 5 Minute Puppy Video in people with Stress Reaction and Behavior, Social, run by University of Chicago 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 5 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 19 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03949569, which also lists 50 linked publications.
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 19 Sep 2024.