Clinical trial NCT03249116: Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions
Official title: Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions for Adolescents With Social aAnxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Social Anxiety
Social Anxiety Disorder of Childhood
Keywords: human-animal interaction
animal-assisted intervention
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 75
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Adolescence and young adulthood is a critical period for the development of social anxiety, which is often linked to other mental health challenges such as depression, mood disorders, and substance abuse. Initial evidence suggests that interacting with animals can reduce stress and anxiety, but no research has tested whether this benefit extends to adolescents at risk for social anxiety disorder. Additionally, researchers and clinicians do not understand what mechanism is responsible for anxiety reduction in animal-assisted interventions (AAIs). Therefore, the objectives of this study are to explore the specific mechanisms by which interacting with a therapy dog reduces anxiety, and to test whether such an interaction reduces anxiety in adolescents with varying levels of social anxiety.

Detailed description: The specific aims of this project are to (1) test the mechanisms by which AAIs reduce anxiety, and (2) determine if the anxiolytic effect of social and physical interaction is moderated by level of pre-existing social anxiety. To achieve these aims, 75 adolescents (age 13-17) will undergo a well-validated laboratory-based social evaluative stressor, the Trier Social Stress Task for Children, and be randomly assigned to one of three conditions: 1) no interaction with a dog (control condition), 2) social interaction only (no physical interaction) with a therapy dog; or 3) social interaction plus physical interaction with a therapy dog. Using a multivariate approach, three levels of outcome data will be collected: a) self-reported experience (anxiety), b) autonomic physiology (heart rate), and c) behavioral performance (error rates on mental math task). In addition, the interactions will be videotaped and behavioral coding will be used to explore the specific social behaviors between the participant and the dog that may predict anxiety reduction (such as frequency or type of social referencing or physical contact).

Eligibility criteria: Inclusion Criteria:

- Low, mid-range, and high levels of social anxiety

Exclusion Criteria:

* Fear of dogs
* Allergy to dogs

Primary outcomes:
measure: Self-reported Affective Experience
timeFrame: Self-reported anxiety was measured at six time points, during: (Time 1; 0 min) baseline, (Time 2; 30 min) anticipation, (Time 3; 35 min) preparation, (Time 4; 45 min) speech, (Time 5; 60 min) recovery period 1, and (Time 6; 75 min) recovery period 2.
Secondary outcomes:
measure: Autonomic Physiological Reactivity: Electrodermal Activity
timeFrame: Continuous through the 2 hour experiment.
measure: Autonomic Reactivity: Heart Rate
timeFrame: continuous through the 2 hour experiment
measure: Cognitive Performance - Number of Errors
timeFrame: 1 hour into 2 hour experiment
measure: Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses
timeFrame: 1 hour into 2 hour experiment
Other outcomes:
Locations:
city: North Grafton
country: United States
facility: Cummings School of Veterinary Medicine at Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Megan K Mueller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mueller MK, Anderson EC, King EK, Urry HL. Null effects of therapy dog interaction on adolescent anxiety during a laboratory-based social evaluative stressor. Anxiety Stress Coping. 2021 Jul;34(4):365-380. doi: 10.1080/10615806.2021.1892084. Epub 2021 Mar 2.