The Effects of Therapy Dogs on Child Biology and Behavior

Stress Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03949569
• Other study ID #: IRB18-0472
• Secondary ID: R21HD094956
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2019
• Source: University of Chicago
• Contact: Kristen C Jacobson, PhD
• Phone: (773)834-0265
• Email: kjacobso[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Social
• Fractures, Stress
• Stress Reaction

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Level and Change in Salivary Oxytocin (pending additional funds)	Salivary oxytocin will be measured repeatedly during the study visit.	Assessed immediately before and after each intervention.
Primary	Mean level and Change in Salivary cortisol	Salivary cortisol will be collected 7 times during the study visit.	Measured at baseline and over a 45 minute period before and after the psychosocial stress test
Primary	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.	Assessed after the 2nd intervention.
Primary	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.	Assessed after the 2nd intervention.
Secondary	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 at the beginning of the study visit and before and after each intervention.
Secondary	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.	Assessed during both interventions and during the psychosocial stress test.
Secondary	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.	Assessed during both interventions and during the psychosocial stress test.