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The Effects of Therapy Dogs on Child Biology and Behavior

A Pilot Study of the Effects of Interactions With Therapy Dogs on Child Stress Responsivity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03949569
Enrollment
188
Registered
2019-05-14
Start date
2019-06-15
Completion date
2022-01-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Social, Stress Reaction

Keywords

Children, Human-Animal Interaction, Stress, Cortisol

Brief 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.

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.

Interventions

BEHAVIORALTherapy 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.

BEHAVIORALStuffed 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.

BEHAVIORAL5 Minute Puppy Video

Children will watch a 5 minute puppy video.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

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.

Intervention 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

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mean level and Change in Salivary cortisolMeasured at baseline and over a 45 minute period before and after the psychosocial stress testSalivary cortisol will be collected 7 times during the study visit.
Mean level Prosocial behavior assessed with the Zurich prosocial gameAssessed 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, OperationAssessed 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.

Secondary

MeasureTime frameDescription
Mean level and Change in Psychological Well Being assessed by the Positive and Negative Affect Scale for Children (PANAS-C)Measured at the beginning of the study visit and before and after each intervention.The PANAS-C will be administered repeatedly during the study visit.
Mean level and Change in galvanic skin response measured with the E4 wristbandAssessed during both interventions and during the psychosocial stress test.Participants will wear an E4 wristband during the study visit that records continuous physiological markers of stress.
Mean level and Change in heart rate measured with the E4 wristbandAssessed during both interventions and during the psychosocial stress test.Participants will wear an E4 wristband during the study visit that records continuous physiological markers of stress.

Other

MeasureTime frameDescription
Mean Level and Change in Salivary Oxytocin (pending additional funds)Assessed immediately before and after each intervention.Salivary oxytocin will be measured repeatedly during the study visit.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026