The Effects of Therapy Dogs on Child Biology and Behavior
NCT ID: NCT03949569
Last Updated: 2024-09-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
188 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-06-15
Study Completion Date
2022-01-31
Brief Summary
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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.
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Detailed Description
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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.
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
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Stress Reaction
Behavior, Social
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
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
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Participants will be unaware of which study arm they are assigned. Individuals performing the interventions will be blind to study condition. The investigator will be blind to study condition until data analysis. Video data will be coded by observers blind to the study condition. The primary outcomes assessor is not blind to study condition.
Study Groups
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Arm 1
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.
Group Type
EXPERIMENTAL
Therapy Dog
Intervention Type
BEHAVIORAL
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 Dog
Intervention Type
BEHAVIORAL
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.
Arm 2
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.
Group Type
EXPERIMENTAL
Therapy Dog
Intervention Type
BEHAVIORAL
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 Dog
Intervention Type
BEHAVIORAL
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.
Arm 3
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.
Group Type
EXPERIMENTAL
Stuffed Toy Dog
Intervention Type
BEHAVIORAL
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 Video
Intervention Type
BEHAVIORAL
Children will watch a 5 minute puppy video.
Interventions
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Therapy Dog
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.
Intervention Type
BEHAVIORAL
Stuffed Toy Dog
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.
Intervention Type
BEHAVIORAL
5 Minute Puppy Video
Children will watch a 5 minute puppy video.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
\- Children between the ages of 8-12 years old
Exclusion Criteria
* 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
* Severe neurological, medical, or psychiatric illnesses (e.g., schizophrenia, psychosis)
* Severe asthma or animal allergies
* Animal phobias
* Use of medications that affect cortisol
Minimum Eligible Age
8 Years
Maximum Eligible Age
12 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
collaborator
University of Chicago
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Kristen C Jacobson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago Medical Center
Chicago, Illinois, United States
Site Status
Countries
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United States
References
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Other Identifiers
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IRB18-0472
Identifier Type: -
Identifier Source: org_study_id
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