Social Anxiety, Social Anxiety Disorder, Social Anxiety Disorder of Childhood
Conditions
Keywords
human-animal interaction, animal-assisted intervention
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).
Interventions
Interaction with a therapy dog
OTHERactive control
Interaction with a stuffed dog
Sponsors
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
\- Low, mid-range, and high levels of social anxiety
Exclusion criteria
* Fear of dogs * Allergy to dogs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Affective Experience | 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. | The state scale of the State-Trait Anxiety Inventory (STAI) was used to measure state-level anxiety. We used the six-item short form of the STAI, which asks participants to rate how each of the six words reflects their feelings (calm, upset, relaxed, worried, tense, content). The short form was originally administered as a four-point scale, which we further modified to a three-point scale for feasibility in administering repeatedly over a short time period (response options for each item followed the format: very calm, calm, not calm). Responses to the six items were used to create a sum score at each time point with a possible range of 3 to 18 (higher scores indicate higher levels of anxiety). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Autonomic Physiological Reactivity: Electrodermal Activity | Continuous through the 2 hour experiment. | Electrodermal activity (EDA) was recorded at 4 Hz by an Empatica E4 wristband sensor. EDA is reported in μSiemens with higher values representing higher levels of autonomic reactivity. EDA was recorded continuously, and for analysis was assessed over six time windows during the experiment: Time 1 = beginning of study; Time 2 = baseline period; Time 3 = anticipation phase; Time 4 = last 5 min of the stressor; Time 5 = recovery 1; Time 6 = recovery 2. Each time point was 5 minutes in duration. |
| Autonomic Reactivity: Heart Rate | continuous through the 2 hour experiment | Heart rate (beats per minute) Heart rate was measured via photoplethysmography from the Empatica E4 wristband using Empatica's proprietary algorithm, which automatically imputes missing data from the photoplethysmograph signal and corrects for motion artifacts. The heart rate is computed as the average heart rate values that spans 10 seconds. This average HR is computed at 1 Hz. HRwas recorded continuously, and for analysis was assessed over six time windows during the experiment: Time 1 = beginning of study; Time 2 = baseline period; Time 3 = anticipation phase; Time 4 = last 5 min of the stressor; Time 5 = recovery 1; Time 6 = recovery 2. Each time point was 5 minutes in duration. |
| Cognitive Performance - Number of Errors | 1 hour into 2 hour experiment | Number of errors (incorrect answer to subtraction task) during mental math task; better performance was characterized by fewer errors. Number of errors ranged from 0 to 8. |
| Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses | 1 hour into 2 hour experiment | Highest number of correct responses in serial subtraction task. To adjust for the different levels of subtraction based on age level, lowest number reached was operationalized by calculating the number of correct responses (a higher score indicating better performance). Number of correct answers ranged from 1 to 41. |
Countries
United States
Participant flow
Recruitment details
Participants were 75 adolescents ages 13-17 on a continuum of social anxiety who were recruited through convenience and snowball sampling via local libraries and youth centers, social media, and other public venues.
Participants by arm
| Arm | Count |
|---|---|
| Control - Interaction With a Stuffed Dog Active control - interaction with a stuffed dog | 25 |
| Therapy Dog - Social animal-assisted intervention - social interaction only with therapy dog during TSST.
animal-assisted intervention: Interaction with a therapy dog | 25 |
| Therapy Dog - Social + Physical animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.
animal-assisted intervention: Interaction with a therapy dog | 25 |
| Total | 75 |
Baseline characteristics
| Characteristic | Therapy Dog - Social | Control - Interaction With a Stuffed Dog | Total | Therapy Dog - Social + Physical |
|---|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 25 Participants | 75 Participants | 25 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15.4 years STANDARD_DEVIATION 1.6 | 15.4 years STANDARD_DEVIATION 1.4 | 15.5 years STANDARD_DEVIATION 1.4 | 15.7 years STANDARD_DEVIATION 1.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 25 Participants | 71 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Pet ownership | 17 Participants | 19 Participants | 56 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 22 Participants | 65 Participants | 20 Participants |
| Region of Enrollment United States | 25 Participants | 25 Participants | 75 Participants | 25 Participants |
| Sex: Female, Male Female | 22 Participants | 17 Participants | 46 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 29 Participants | 18 Participants |
| Social anxiety level High Anxiety | 13 Participants | 10 Participants | 35 Participants | 12 Participants |
| Social anxiety level Low Anxiety | 6 Participants | 8 Participants | 18 Participants | 4 Participants |
| Social anxiety level Mid Anxiety | 6 Participants | 7 Participants | 22 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
Self-reported Affective Experience
The state scale of the State-Trait Anxiety Inventory (STAI) was used to measure state-level anxiety. We used the six-item short form of the STAI, which asks participants to rate how each of the six words reflects their feelings (calm, upset, relaxed, worried, tense, content). The short form was originally administered as a four-point scale, which we further modified to a three-point scale for feasibility in administering repeatedly over a short time period (response options for each item followed the format: very calm, calm, not calm). Responses to the six items were used to create a sum score at each time point with a possible range of 3 to 18 (higher scores indicate higher levels of anxiety).
Time frame: 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.
Population: 7 participants were excluded due to protocol deviations (not following study directions), and 2 had missing data for self-reported affective experience.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control - Stuffed Dog | Self-reported Affective Experience | Time 1 - 0 min | 10.19 units on a scale | Standard Deviation 1.81 |
| Control - Stuffed Dog | Self-reported Affective Experience | Time 2 - 30 min | 8.33 units on a scale | Standard Deviation 1.88 |
| Control - Stuffed Dog | Self-reported Affective Experience | Time 4 - 45 min | 13.57 units on a scale | Standard Deviation 2.4 |
| Control - Stuffed Dog | Self-reported Affective Experience | Time 5 - 60 min | 9.33 units on a scale | Standard Deviation 1.53 |
| Control - Stuffed Dog | Self-reported Affective Experience | Time 6 - 75 min | 8.43 units on a scale | Standard Deviation 1.43 |
| Control - Stuffed Dog | Self-reported Affective Experience | Time 3 - 35 min | 12.05 units on a scale | Standard Deviation 2.01 |
| Therapy Dog - Social | Self-reported Affective Experience | Time 3 - 35 min | 11.96 units on a scale | Standard Deviation 2.44 |
| Therapy Dog - Social | Self-reported Affective Experience | Time 4 - 45 min | 13.14 units on a scale | Standard Deviation 2.32 |
| Therapy Dog - Social | Self-reported Affective Experience | Time 6 - 75 min | 8.52 units on a scale | Standard Deviation 1.44 |
| Therapy Dog - Social | Self-reported Affective Experience | Time 5 - 60 min | 9.14 units on a scale | Standard Deviation 1.93 |
| Therapy Dog - Social | Self-reported Affective Experience | Time 1 - 0 min | 10.00 units on a scale | Standard Deviation 2.07 |
| Therapy Dog - Social | Self-reported Affective Experience | Time 2 - 30 min | 8.05 units on a scale | Standard Deviation 1.32 |
| Therapy Dog - Social + Physical | Self-reported Affective Experience | Time 5 - 60 min | 8.68 units on a scale | Standard Deviation 2.51 |
| Therapy Dog - Social + Physical | Self-reported Affective Experience | Time 3 - 35 min | 12.36 units on a scale | Standard Deviation 2.18 |
| Therapy Dog - Social + Physical | Self-reported Affective Experience | Time 6 - 75 min | 8.72 units on a scale | Standard Deviation 2.01 |
| Therapy Dog - Social + Physical | Self-reported Affective Experience | Time 2 - 30 min | 7.88 units on a scale | Standard Deviation 1.67 |
| Therapy Dog - Social + Physical | Self-reported Affective Experience | Time 4 - 45 min | 13.40 units on a scale | Standard Deviation 2.4 |
| Therapy Dog - Social + Physical | Self-reported Affective Experience | Time 1 - 0 min | 10.28 units on a scale | Standard Deviation 1.6 |
p-value: 0.723ANOVA
Secondary
Autonomic Physiological Reactivity: Electrodermal Activity
Electrodermal activity (EDA) was recorded at 4 Hz by an Empatica E4 wristband sensor. EDA is reported in μSiemens with higher values representing higher levels of autonomic reactivity. EDA was recorded continuously, and for analysis was assessed over six time windows during the experiment: Time 1 = beginning of study; Time 2 = baseline period; Time 3 = anticipation phase; Time 4 = last 5 min of the stressor; Time 5 = recovery 1; Time 6 = recovery 2. Each time point was 5 minutes in duration.
Time frame: Continuous through the 2 hour experiment.
Population: 7 participants were excluded for having a protocol deviation and 14 participants with EDA data that were not usable (3 of whom also had a protocol deviation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Stuffed Dog | Autonomic Physiological Reactivity: Electrodermal Activity | 7.32 μSiemens | Standard Deviation 3.03 |
| Therapy Dog - Social | Autonomic Physiological Reactivity: Electrodermal Activity | 6.56 μSiemens | Standard Deviation 2.52 |
| Therapy Dog - Social + Physical | Autonomic Physiological Reactivity: Electrodermal Activity | 8.01 μSiemens | Standard Deviation 3.41 |
p-value: 0.271ANOVA
Secondary
Autonomic Reactivity: Heart Rate
Heart rate (beats per minute) Heart rate was measured via photoplethysmography from the Empatica E4 wristband using Empatica's proprietary algorithm, which automatically imputes missing data from the photoplethysmograph signal and corrects for motion artifacts. The heart rate is computed as the average heart rate values that spans 10 seconds. This average HR is computed at 1 Hz. HRwas recorded continuously, and for analysis was assessed over six time windows during the experiment: Time 1 = beginning of study; Time 2 = baseline period; Time 3 = anticipation phase; Time 4 = last 5 min of the stressor; Time 5 = recovery 1; Time 6 = recovery 2. Each time point was 5 minutes in duration.
Time frame: continuous through the 2 hour experiment
Population: 7 participants were excluded due to protocol deviations (not following study directions).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Stuffed Dog | Autonomic Reactivity: Heart Rate | 79.48 Beats per minute | Standard Deviation 7.92 |
| Therapy Dog - Social | Autonomic Reactivity: Heart Rate | 78.73 Beats per minute | Standard Deviation 10.55 |
| Therapy Dog - Social + Physical | Autonomic Reactivity: Heart Rate | 80.44 Beats per minute | Standard Deviation 11.36 |
p-value: 0.638ANOVA
Secondary
Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses
Highest number of correct responses in serial subtraction task. To adjust for the different levels of subtraction based on age level, lowest number reached was operationalized by calculating the number of correct responses (a higher score indicating better performance). Number of correct answers ranged from 1 to 41.
Time frame: 1 hour into 2 hour experiment
Population: 7 participants were excluded due to protocol deviations (not following study directions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Stuffed Dog | Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses | 12.95 highest number of correct responses | Standard Deviation 8.85 |
| Therapy Dog - Social | Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses | 13.41 highest number of correct responses | Standard Deviation 9.48 |
| Therapy Dog - Social + Physical | Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses | 14.92 highest number of correct responses | Standard Deviation 12.59 |
p-value: 0.809ANOVA
Secondary
Cognitive Performance - Number of Errors
Number of errors (incorrect answer to subtraction task) during mental math task; better performance was characterized by fewer errors. Number of errors ranged from 0 to 8.
Time frame: 1 hour into 2 hour experiment
Population: 7 participants were excluded due to protocol deviations (not following study directions).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Stuffed Dog | Cognitive Performance - Number of Errors | 3.29 number of errors | Standard Deviation 1.95 |
| Therapy Dog - Social | Cognitive Performance - Number of Errors | 3.36 number of errors | Standard Deviation 2.24 |
| Therapy Dog - Social + Physical | Cognitive Performance - Number of Errors | 3.20 number of errors | Standard Deviation 2.2 |
p-value: 0.868ANOVA