<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03249116</url>
  </required_header>
  <id_info>
    <org_study_id>1R03HD091892-01</org_study_id>
    <nct_id>NCT03249116</nct_id>
  </id_info>
  <brief_title>Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions</brief_title>
  <official_title>Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions for Adolescents With Social aAnxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tufts University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adolescence and young adulthood is a critical period for the development of social anxiety,&#xD;
      which is often linked to other mental health challenges such as depression, mood disorders,&#xD;
      and substance abuse. Initial evidence suggests that interacting with animals can reduce&#xD;
      stress and anxiety, but no research has tested whether this benefit extends to adolescents at&#xD;
      risk for social anxiety disorder. Additionally, researchers and clinicians do not understand&#xD;
      what mechanism is responsible for anxiety reduction in animal-assisted interventions (AAIs).&#xD;
      Therefore, the objectives of this study are to explore the specific mechanisms by which&#xD;
      interacting with a therapy dog reduces anxiety, and to test whether such an interaction&#xD;
      reduces anxiety in adolescents with varying levels of social anxiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The specific aims of this project are to (1) test the mechanisms by which AAIs reduce&#xD;
      anxiety, and (2) determine if the anxiolytic effect of social and physical interaction is&#xD;
      moderated by level of pre-existing social anxiety. To achieve these aims, 75 adolescents (age&#xD;
      13-17) will undergo a well-validated laboratory-based social evaluative stressor, the Trier&#xD;
      Social Stress Task for Children, and be randomly assigned to one of three conditions: 1) no&#xD;
      interaction with a dog (control condition), 2) social interaction only (no physical&#xD;
      interaction) with a therapy dog; or 3) social interaction plus physical interaction with a&#xD;
      therapy dog. Using a multivariate approach, three levels of outcome data will be collected:&#xD;
      a) self-reported experience (anxiety), b) autonomic physiology (heart rate), and c)&#xD;
      behavioral performance (error rates on mental math task). In addition, the interactions will&#xD;
      be videotaped and behavioral coding will be used to explore the specific social behaviors&#xD;
      between the participant and the dog that may predict anxiety reduction (such as frequency or&#xD;
      type of social referencing or physical contact).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported Affective Experience</measure>
    <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.</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Autonomic Physiological Reactivity: Electrodermal Activity</measure>
    <time_frame>Continuous through the 2 hour experiment.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomic Reactivity: Heart Rate</measure>
    <time_frame>continuous through the 2 hour experiment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Performance - Number of Errors</measure>
    <time_frame>1 hour into 2 hour experiment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses</measure>
    <time_frame>1 hour into 2 hour experiment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Social Anxiety Disorder</condition>
  <condition>Social Anxiety</condition>
  <condition>Social Anxiety Disorder of Childhood</condition>
  <arm_group>
    <arm_group_label>Control - interaction with a stuffed dog</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active control - interaction with a stuffed dog</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Therapy dog - social</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>animal-assisted intervention - social interaction only with therapy dog during stress task.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Therapy dog - Social + physical</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>animal-assisted intervention - Social interaction and physical interaction with therapy dog during stress task.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>animal-assisted intervention</intervention_name>
    <description>Interaction with a therapy dog</description>
    <arm_group_label>Therapy dog - Social + physical</arm_group_label>
    <arm_group_label>Therapy dog - social</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>active control</intervention_name>
    <description>Interaction with a stuffed dog</description>
    <arm_group_label>Control - interaction with a stuffed dog</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Low, mid-range, and high levels of social anxiety&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fear of dogs&#xD;
&#xD;
          -  Allergy to dogs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Megan K Mueller, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cummings School of Veterinary Medicine at Tufts University</name>
      <address>
        <city>North Grafton</city>
        <state>Massachusetts</state>
        <zip>01536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <results_first_submitted>April 28, 2020</results_first_submitted>
  <results_first_submitted_qc>September 12, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 8, 2020</results_first_posted>
  <last_update_submitted>September 12, 2020</last_update_submitted>
  <last_update_submitted_qc>September 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tufts University</investigator_affiliation>
    <investigator_full_name>Megan K Mueller</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>human-animal interaction</keyword>
  <keyword>animal-assisted intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Phobia, Social</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03249116/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03249116/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03249116/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <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.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>Active control - interaction with a stuffed dog only</description>
        </group>
        <group group_id="P2">
          <title>Therapy Dog - Social</title>
          <description>animal-assisted intervention - social interaction only with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
        </group>
        <group group_id="P3">
          <title>Therapy Dog - Social + Physical</title>
          <description>animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control - Interaction With a Stuffed Dog</title>
          <description>Active control - interaction with a stuffed dog</description>
        </group>
        <group group_id="B2">
          <title>Therapy Dog - Social</title>
          <description>animal-assisted intervention - social interaction only with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
        </group>
        <group group_id="B3">
          <title>Therapy Dog - Social + Physical</title>
          <description>animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="25"/>
            <count group_id="B4" value="75"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.4" spread="1.4"/>
                    <measurement group_id="B2" value="15.4" spread="1.6"/>
                    <measurement group_id="B3" value="15.7" spread="1.4"/>
                    <measurement group_id="B4" value="15.5" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Social anxiety level</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Low Anxiety</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mid Anxiety</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High Anxiety</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pet ownership</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Self-reported Affective Experience</title>
        <description>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).</description>
        <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.</time_frame>
        <population>7 participants were excluded due to protocol deviations (not following study directions), and 2 had missing data for self-reported affective experience.</population>
        <group_list>
          <group group_id="O1">
            <title>Control - Stuffed Dog</title>
            <description>active control: Interaction with a stuffed dog</description>
          </group>
          <group group_id="O2">
            <title>Therapy Dog - Social</title>
            <description>animal-assisted intervention - social interaction only with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
          </group>
          <group group_id="O3">
            <title>Therapy Dog - Social + Physical</title>
            <description>animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
          </group>
        </group_list>
        <measure>
          <title>Self-reported Affective Experience</title>
          <description>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).</description>
          <population>7 participants were excluded due to protocol deviations (not following study directions), and 2 had missing data for self-reported affective experience.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time 1 - 0 min</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.19" spread="1.81"/>
                    <measurement group_id="O2" value="10.00" spread="2.07"/>
                    <measurement group_id="O3" value="10.28" spread="1.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 2 - 30 min</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.33" spread="1.88"/>
                    <measurement group_id="O2" value="8.05" spread="1.32"/>
                    <measurement group_id="O3" value="7.88" spread="1.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 3 - 35 min</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.05" spread="2.01"/>
                    <measurement group_id="O2" value="11.96" spread="2.44"/>
                    <measurement group_id="O3" value="12.36" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 4 - 45 min</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.57" spread="2.40"/>
                    <measurement group_id="O2" value="13.14" spread="2.32"/>
                    <measurement group_id="O3" value="13.40" spread="2.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 5 - 60 min</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.33" spread="1.53"/>
                    <measurement group_id="O2" value="9.14" spread="1.93"/>
                    <measurement group_id="O3" value="8.68" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time 6 - 75 min</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.43" spread="1.43"/>
                    <measurement group_id="O2" value="8.52" spread="1.44"/>
                    <measurement group_id="O3" value="8.72" spread="2.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.723</p_value>
            <p_value_desc>The threshold for statistical significance was p&lt;.05</p_value_desc>
            <method>ANOVA</method>
            <method_desc>dependent variable: self-reported anxiety between-subjects factors: condition, social anxiety within-subjects factor: time</method_desc>
            <param_type>F statistic</param_type>
            <param_value>0.33</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Autonomic Physiological Reactivity: Electrodermal Activity</title>
        <description>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.</description>
        <time_frame>Continuous through the 2 hour experiment.</time_frame>
        <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)</population>
        <group_list>
          <group group_id="O1">
            <title>Control - Stuffed Dog</title>
            <description>Active control - interaction with a stuffed dog</description>
          </group>
          <group group_id="O2">
            <title>Therapy Dog - Social</title>
            <description>animal-assisted intervention - social interaction only with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
          </group>
          <group group_id="O3">
            <title>Therapy Dog - Social + Physical</title>
            <description>animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
          </group>
        </group_list>
        <measure>
          <title>Autonomic Physiological Reactivity: Electrodermal Activity</title>
          <description>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.</description>
          <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)</population>
          <units>μSiemens</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.32" spread="3.03"/>
                    <measurement group_id="O2" value="6.56" spread="2.52"/>
                    <measurement group_id="O3" value="8.01" spread="3.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.271</p_value>
            <p_value_desc>The threshold for statistical significance was p&lt;.05</p_value_desc>
            <method>ANOVA</method>
            <method_desc>dependent variable: electrodermal activity between-subjects factors: condition, social anxiety within-subjects factor: time</method_desc>
            <param_type>F statistic</param_type>
            <param_value>1.34</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Autonomic Reactivity: Heart Rate</title>
        <description>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.</description>
        <time_frame>continuous through the 2 hour experiment</time_frame>
        <population>7 participants were excluded due to protocol deviations (not following study directions).</population>
        <group_list>
          <group group_id="O1">
            <title>Control - Stuffed Dog</title>
            <description>active control: Interaction with a stuffed dog</description>
          </group>
          <group group_id="O2">
            <title>Therapy Dog - Social</title>
            <description>animal-assisted intervention - social interaction only with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
          </group>
          <group group_id="O3">
            <title>Therapy Dog - Social + Physical</title>
            <description>animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
          </group>
        </group_list>
        <measure>
          <title>Autonomic Reactivity: Heart Rate</title>
          <description>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.</description>
          <population>7 participants were excluded due to protocol deviations (not following study directions).</population>
          <units>Beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.48" spread="7.92"/>
                    <measurement group_id="O2" value="78.73" spread="10.55"/>
                    <measurement group_id="O3" value="80.44" spread="11.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.638</p_value>
            <p_value_desc>The threshold for statistical significance was p&lt;.05</p_value_desc>
            <method>ANOVA</method>
            <method_desc>dependent variable: heart rate between-subjects factors: condition, social anxiety within-subjects factor: time</method_desc>
            <param_type>F statistic</param_type>
            <param_value>0.45</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cognitive Performance - Number of Errors</title>
        <description>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.</description>
        <time_frame>1 hour into 2 hour experiment</time_frame>
        <population>7 participants were excluded due to protocol deviations (not following study directions).</population>
        <group_list>
          <group group_id="O1">
            <title>Control - Stuffed Dog</title>
            <description>active control: Interaction with a stuffed dog</description>
          </group>
          <group group_id="O2">
            <title>Therapy Dog - Social</title>
            <description>animal-assisted intervention - social interaction only with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
          </group>
          <group group_id="O3">
            <title>Therapy Dog - Social + Physical</title>
            <description>animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive Performance - Number of Errors</title>
          <description>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.</description>
          <population>7 participants were excluded due to protocol deviations (not following study directions).</population>
          <units>number of errors</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.29" spread="1.95"/>
                    <measurement group_id="O2" value="3.36" spread="2.24"/>
                    <measurement group_id="O3" value="3.20" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.868</p_value>
            <p_value_desc>The threshold for statistical significance was p&lt;.05</p_value_desc>
            <method>ANOVA</method>
            <method_desc>dependent variable: number of errors between-subjects factors: condition, social anxiety</method_desc>
            <param_type>F statistic</param_type>
            <param_value>0.14</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses</title>
        <description>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.</description>
        <time_frame>1 hour into 2 hour experiment</time_frame>
        <population>7 participants were excluded due to protocol deviations (not following study directions)</population>
        <group_list>
          <group group_id="O1">
            <title>Control - Stuffed Dog</title>
            <description>active control: Interaction with a stuffed dog</description>
          </group>
          <group group_id="O2">
            <title>Therapy Dog - Social</title>
            <description>animal-assisted intervention - social interaction only with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
          </group>
          <group group_id="O3">
            <title>Therapy Dog - Social + Physical</title>
            <description>animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses</title>
          <description>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.</description>
          <population>7 participants were excluded due to protocol deviations (not following study directions)</population>
          <units>highest number of correct responses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.95" spread="8.85"/>
                    <measurement group_id="O2" value="13.41" spread="9.48"/>
                    <measurement group_id="O3" value="14.92" spread="12.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.809</p_value>
            <p_value_desc>The threshold for statistical significance was p&lt;.05</p_value_desc>
            <method>ANOVA</method>
            <method_desc>dependent variable: lowest number reached/highest number of correct responses between-subjects factors: condition, social anxiety</method_desc>
            <param_type>F statistic</param_type>
            <param_value>0.21</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>75 minutes</time_frame>
      <desc>Adverse events systematically collected for each participant via a standardized recording sheet. No adverse events occurred.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>Active control - interaction with a therapy dog&#xD;
active control: Interaction with a stuffed dog</description>
        </group>
        <group group_id="E2">
          <title>Therapy Dog - Social</title>
          <description>animal-assisted intervention - social interaction only with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
        </group>
        <group group_id="E3">
          <title>Therapy Dog - Social + Physical</title>
          <description>animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.&#xD;
animal-assisted intervention: Interaction with a therapy dog</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Heart rate data was of poor quality due to movement artifacts and therefore unable to be reliably interpreted.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Megan K Mueller</name_or_title>
      <organization>Tufts University</organization>
      <phone>508-887-4543</phone>
      <email>megan.mueller@tufts.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03249116
org study id: 1R03HD091892-01
nct id: NCT03249116
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Self-reported Affective Experience
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.
description: 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).
measure: Autonomic Physiological Reactivity: Electrodermal Activity
time frame: Continuous through the 2 hour experiment.
description: 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.
measure: Autonomic Reactivity: Heart Rate
time frame: continuous through the 2 hour experiment
description: 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.
measure: Cognitive Performance - Number of Errors
time frame: 1 hour into 2 hour experiment
description: 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.
measure: Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses
time frame: 1 hour into 2 hour experiment
description: 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.
arm group label: Control - interaction with a stuffed dog
arm group type: Active Comparator
description: Active control - interaction with a stuffed dog
arm group label: Therapy dog - social
arm group type: Experimental
description: animal-assisted intervention - social interaction only with therapy dog during stress task.
arm group label: Therapy dog - Social + physical
arm group type: Experimental
description: animal-assisted intervention - Social interaction and physical interaction with therapy dog during stress task.
intervention type: Other
intervention name: animal-assisted intervention
description: Interaction with a therapy dog
arm group label: Therapy dog - Social + physical
arm group label: Therapy dog - social
intervention type: Other
intervention name: active control
description: Interaction with a stuffed dog
arm group label: Control - interaction with a stuffed dog
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Megan K Mueller, PhD
role: Principal Investigator
affiliation: Tufts University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Tufts University
investigator full name: Megan K Mueller
investigator title: Assistant Professor
mesh term: Anxiety Disorders
mesh term: Phobia, Social
provided document: 
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Heart rate data was of poor quality due to movement artifacts and therefore unable to be reliably interpreted.
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