Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT03249116
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2017-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}, {'id': 'D000081762', 'term': 'Human-Animal Interaction'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'megan.mueller@tufts.edu', 'phone': '508-887-4543', 'title': 'Dr. Megan K Mueller', 'organization': 'Tufts University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Heart rate data was of poor quality due to movement artifacts and therefore unable to be reliably interpreted.'}}, 'adverseEventsModule': {'timeFrame': '75 minutes', 'description': 'Adverse events systematically collected for each participant via a standardized recording sheet. No adverse events occurred.', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Active control - interaction with a therapy dog\n\nactive control: Interaction with a stuffed dog', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Therapy Dog - Social', 'description': 'animal-assisted intervention - social interaction only with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Therapy Dog - Social + Physical', 'description': 'animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Self-reported Affective Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control - Stuffed Dog', 'description': 'active control: Interaction with a stuffed dog'}, {'id': 'OG001', 'title': 'Therapy Dog - Social', 'description': 'animal-assisted intervention - social interaction only with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}, {'id': 'OG002', 'title': 'Therapy Dog - Social + Physical', 'description': 'animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}], 'classes': [{'title': 'Time 1 - 0 min', 'categories': [{'measurements': [{'value': '10.19', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '10.00', 'spread': '2.07', 'groupId': 'OG001'}, {'value': '10.28', 'spread': '1.60', 'groupId': 'OG002'}]}]}, {'title': 'Time 2 - 30 min', 'categories': [{'measurements': [{'value': '8.33', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '8.05', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '7.88', 'spread': '1.67', 'groupId': 'OG002'}]}]}, {'title': 'Time 3 - 35 min', 'categories': [{'measurements': [{'value': '12.05', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '11.96', 'spread': '2.44', 'groupId': 'OG001'}, {'value': '12.36', 'spread': '2.18', 'groupId': 'OG002'}]}]}, {'title': 'Time 4 - 45 min', 'categories': [{'measurements': [{'value': '13.57', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '13.14', 'spread': '2.32', 'groupId': 'OG001'}, {'value': '13.40', 'spread': '2.40', 'groupId': 'OG002'}]}]}, {'title': 'Time 5 - 60 min', 'categories': [{'measurements': [{'value': '9.33', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '9.14', 'spread': '1.93', 'groupId': 'OG001'}, {'value': '8.68', 'spread': '2.51', 'groupId': 'OG002'}]}]}, {'title': 'Time 6 - 75 min', 'categories': [{'measurements': [{'value': '8.43', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '8.52', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '8.72', 'spread': '2.01', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.723', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'F statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.33', 'pValueComment': 'The threshold for statistical significance was p\\<.05', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'dependent variable: self-reported anxiety between-subjects factors: condition, social anxiety within-subjects factor: time'}], 'paramType': 'MEAN', '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.', '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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '7 participants were excluded due to protocol deviations (not following study directions), and 2 had missing data for self-reported affective experience.'}, {'type': 'SECONDARY', 'title': 'Autonomic Physiological Reactivity: Electrodermal Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control - Stuffed Dog', 'description': 'Active control - interaction with a stuffed dog'}, {'id': 'OG001', 'title': 'Therapy Dog - Social', 'description': 'animal-assisted intervention - social interaction only with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}, {'id': 'OG002', 'title': 'Therapy Dog - Social + Physical', 'description': 'animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}], 'classes': [{'categories': [{'measurements': [{'value': '7.32', 'spread': '3.03', 'groupId': 'OG000'}, {'value': '6.56', 'spread': '2.52', 'groupId': 'OG001'}, {'value': '8.01', 'spread': '3.41', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.271', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'F statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.34', 'pValueComment': 'The threshold for statistical significance was p\\<.05', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'dependent variable: electrodermal activity between-subjects factors: condition, social anxiety within-subjects factor: time'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'unitOfMeasure': 'μSiemens', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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)'}, {'type': 'SECONDARY', 'title': 'Autonomic Reactivity: Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control - Stuffed Dog', 'description': 'active control: Interaction with a stuffed dog'}, {'id': 'OG001', 'title': 'Therapy Dog - Social', 'description': 'animal-assisted intervention - social interaction only with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}, {'id': 'OG002', 'title': 'Therapy Dog - Social + Physical', 'description': 'animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}], 'classes': [{'categories': [{'measurements': [{'value': '79.48', 'spread': '7.92', 'groupId': 'OG000'}, {'value': '78.73', 'spread': '10.55', 'groupId': 'OG001'}, {'value': '80.44', 'spread': '11.36', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.638', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'F statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.45', 'pValueComment': 'The threshold for statistical significance was p\\<.05', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'dependent variable: heart rate between-subjects factors: condition, social anxiety within-subjects factor: time'}], 'paramType': 'MEAN', 'timeFrame': '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.", 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '7 participants were excluded due to protocol deviations (not following study directions).'}, {'type': 'SECONDARY', 'title': 'Cognitive Performance - Number of Errors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control - Stuffed Dog', 'description': 'active control: Interaction with a stuffed dog'}, {'id': 'OG001', 'title': 'Therapy Dog - Social', 'description': 'animal-assisted intervention - social interaction only with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}, {'id': 'OG002', 'title': 'Therapy Dog - Social + Physical', 'description': 'animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}], 'classes': [{'categories': [{'measurements': [{'value': '3.29', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '3.36', 'spread': '2.24', 'groupId': 'OG001'}, {'value': '3.20', 'spread': '2.20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.868', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'F statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.14', 'pValueComment': 'The threshold for statistical significance was p\\<.05', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'dependent variable: number of errors between-subjects factors: condition, social anxiety'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'unitOfMeasure': 'number of errors', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '7 participants were excluded due to protocol deviations (not following study directions).'}, {'type': 'SECONDARY', 'title': 'Cognitive Performance - Lowest Number Reached/Highest Number of Correct Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control - Stuffed Dog', 'description': 'active control: Interaction with a stuffed dog'}, {'id': 'OG001', 'title': 'Therapy Dog - Social', 'description': 'animal-assisted intervention - social interaction only with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}, {'id': 'OG002', 'title': 'Therapy Dog - Social + Physical', 'description': 'animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}], 'classes': [{'categories': [{'measurements': [{'value': '12.95', 'spread': '8.85', 'groupId': 'OG000'}, {'value': '13.41', 'spread': '9.48', 'groupId': 'OG001'}, {'value': '14.92', 'spread': '12.59', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.809', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'F statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.21', 'pValueComment': 'The threshold for statistical significance was p\\<.05', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'dependent variable: lowest number reached/highest number of correct responses between-subjects factors: condition, social anxiety'}], 'paramType': 'MEAN', 'timeFrame': '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.', 'unitOfMeasure': 'highest number of correct responses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '7 participants were excluded due to protocol deviations (not following study directions)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Active control - interaction with a stuffed dog only'}, {'id': 'FG001', 'title': 'Therapy Dog - Social', 'description': 'animal-assisted intervention - social interaction only with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}, {'id': 'FG002', 'title': 'Therapy Dog - Social + Physical', 'description': 'animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control - Interaction With a Stuffed Dog', 'description': 'Active control - interaction with a stuffed dog'}, {'id': 'BG001', 'title': 'Therapy Dog - Social', 'description': 'animal-assisted intervention - social interaction only with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}, {'id': 'BG002', 'title': 'Therapy Dog - Social + Physical', 'description': 'animal-assisted intervention - Social interaction and physical interaction with therapy dog during TSST.\n\nanimal-assisted intervention: Interaction with a therapy dog'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '15.4', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '15.7', 'spread': '1.4', 'groupId': 'BG002'}, {'value': '15.5', 'spread': '1.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Social anxiety level', 'classes': [{'categories': [{'title': 'Low Anxiety', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Mid Anxiety', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'High Anxiety', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pet ownership', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-31', 'size': 272572, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-29T12:50', 'hasProtocol': True}, {'date': '2019-01-31', 'size': 1699843, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-10-29T12:51', 'hasProtocol': False}, {'date': '2020-04-22', 'size': 63258, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-22T09:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-12', 'studyFirstSubmitDate': '2017-08-08', 'resultsFirstSubmitDate': '2020-04-28', 'studyFirstSubmitQcDate': '2017-08-10', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-12', 'studyFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', '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).'}], 'secondaryOutcomes': [{'measure': 'Autonomic Physiological Reactivity: Electrodermal Activity', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['human-animal interaction', 'animal-assisted intervention'], 'conditions': ['Social Anxiety Disorder', 'Social Anxiety', 'Social Anxiety Disorder of Childhood']}, 'referencesModule': {'references': [{'pmid': '33650444', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Low, mid-range, and high levels of social anxiety\n\nExclusion Criteria:\n\n* Fear of dogs\n* Allergy to dogs'}, 'identificationModule': {'nctId': 'NCT03249116', 'briefTitle': 'Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'Assessing Mechanisms of Anxiety Reduction in Animal-assisted Interventions for Adolescents With Social aAnxiety', 'orgStudyIdInfo': {'id': '1R03HD091892-01', 'link': 'https://reporter.nih.gov/quickSearch/1R03HD091892-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control - interaction with a stuffed dog', 'description': 'Active control - interaction with a stuffed dog', 'interventionNames': ['Other: active control']}, {'type': 'EXPERIMENTAL', 'label': 'Therapy dog - social', 'description': 'animal-assisted intervention - social interaction only with therapy dog during stress task.', 'interventionNames': ['Other: animal-assisted intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Therapy dog - Social + physical', 'description': 'animal-assisted intervention - Social interaction and physical interaction with therapy dog during stress task.', 'interventionNames': ['Other: animal-assisted intervention']}], 'interventions': [{'name': 'animal-assisted intervention', 'type': 'OTHER', 'description': 'Interaction with a therapy dog', 'armGroupLabels': ['Therapy dog - Social + physical', 'Therapy dog - social']}, {'name': 'active control', 'type': 'OTHER', 'description': 'Interaction with a stuffed dog', 'armGroupLabels': ['Control - interaction with a stuffed dog']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01536', 'city': 'North Grafton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Cummings School of Veterinary Medicine at Tufts University', 'geoPoint': {'lat': 42.23343, 'lon': -71.70785}}], 'overallOfficials': [{'name': 'Megan K Mueller, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tufts University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Megan K Mueller', 'investigatorAffiliation': 'Tufts University'}}}}