Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT03949569
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2019-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Therapy Dogs on Child Biology and Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-26', 'releaseDate': '2025-09-08'}], 'estimatedResultsFirstSubmitDate': '2025-09-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015775', 'term': 'Fractures, Stress'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D000081762', 'term': 'Human-Animal Interaction'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Participants will be unaware of which study arm they are assigned. Individuals performing the interventions will be blind to study condition. The investigator will be blind to study condition until data analysis. Video data will be coded by observers blind to the study condition. The primary outcomes assessor is not blind to study condition.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The investigators will use a randomized crossover design. All children will receive two interventions during a single study visit. Children will be assigned to one of three research design arms using a stratified random sampling approach with child sex balanced across arm (N=110 in each group). All children will participate in the same tasks, in the same order. The only difference between research design arms is the timing of the interventions. In one arm the child will interact with the therapy dog prior to the psychosocial stress test and will interact with the stuffed toy dog prior to the behavioral tasks; the reverse is true for children in the second arm. In the third arm, the child will watch a 5 minute puppy video prior to the psychosocial stress test and will interact with the stuffed toy dog prior to the behavioral tasks'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2019-04-05', 'studyFirstSubmitQcDate': '2019-05-10', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean Level and Change in Salivary Oxytocin (pending additional funds)', 'timeFrame': 'Assessed immediately before and after each intervention.', 'description': 'Salivary oxytocin will be measured repeatedly during the study visit.'}], 'primaryOutcomes': [{'measure': 'Mean level and Change in Salivary cortisol', 'timeFrame': 'Measured at baseline and over a 45 minute period before and after the psychosocial stress test', 'description': 'Salivary cortisol will be collected 7 times during the study visit.'}, {'measure': 'Mean level Prosocial behavior assessed with the Zurich prosocial game', 'timeFrame': 'Assessed after the 2nd intervention.', 'description': 'During the study visit prosocial behavior is assessed through total number of helping behaviors recorded during the Zurich prosocial game.'}, {'measure': "Mean level Behavioral carefulness assessed with the children's game, Operation", 'timeFrame': 'Assessed after the 2nd intervention.', 'description': 'During the study visit, participants will play the game Operation. Behavioral carefulness metrics include number of errors and total time to complete the task.'}], 'secondaryOutcomes': [{'measure': 'Mean level and Change in Psychological Well Being assessed by the Positive and Negative Affect Scale for Children (PANAS-C)', 'timeFrame': 'Measured at the beginning of the study visit and before and after each intervention.', 'description': 'The PANAS-C will be administered repeatedly during the study visit.'}, {'measure': 'Mean level and Change in galvanic skin response measured with the E4 wristband', 'timeFrame': 'Assessed during both interventions and during the psychosocial stress test.', 'description': 'Participants will wear an E4 wristband during the study visit that records continuous physiological markers of stress.'}, {'measure': 'Mean level and Change in heart rate measured with the E4 wristband', 'timeFrame': 'Assessed during both interventions and during the psychosocial stress test.', 'description': 'Participants will wear an E4 wristband during the study visit that records continuous physiological markers of stress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children', 'Human-Animal Interaction', 'Stress', 'Cortisol'], 'conditions': ['Stress Reaction', 'Behavior, Social']}, 'referencesModule': {'references': [{'pmid': '20008426', 'type': 'BACKGROUND', 'citation': 'Merikangas KR, He JP, Brody D, Fisher PW, Bourdon K, Koretz DS. 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Epub 2010 Jul 31.'}, {'pmid': '9276783', 'type': 'BACKGROUND', 'citation': 'Lewinsohn PM, Zinbarg R, Seeley JR, Lewinsohn M, Sack WH. Lifetime comorbidity among anxiety disorders and between anxiety disorders and other mental disorders in adolescents. J Anxiety Disord. 1997 Jul-Aug;11(4):377-94. doi: 10.1016/s0887-6185(97)00017-0.'}, {'pmid': '22865617', 'type': 'BACKGROUND', 'citation': 'Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in the United States. Int J Methods Psychiatr Res. 2012 Sep;21(3):169-84. doi: 10.1002/mpr.1359. Epub 2012 Aug 1.'}, {'pmid': '11752480', 'type': 'BACKGROUND', 'citation': 'Kiecolt-Glaser JK, McGuire L, Robles TF, Glaser R. Emotions, morbidity, and mortality: new perspectives from psychoneuroimmunology. 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Measuring stress and immune response in healthcare professionals following interaction with a therapy dog: a pilot study. Psychol Rep. 2005 Jun;96(3 Pt 1):713-29. doi: 10.2466/pr0.96.3.713-729.'}, {'pmid': '20189722', 'type': 'BACKGROUND', 'citation': 'Viau R, Arsenault-Lapierre G, Fecteau S, Champagne N, Walker CD, Lupien S. Effect of service dogs on salivary cortisol secretion in autistic children. Psychoneuroendocrinology. 2010 Sep;35(8):1187-93. doi: 10.1016/j.psyneuen.2010.02.004. Epub 2010 Mar 1.'}, {'pmid': '23162482', 'type': 'BACKGROUND', 'citation': 'Beetz A, Julius H, Turner D, Kotrschal K. Effects of social support by a dog on stress modulation in male children with insecure attachment. Front Psychol. 2012 Sep 28;3:352. doi: 10.3389/fpsyg.2012.00352. eCollection 2012.'}, {'pmid': '2793790', 'type': 'BACKGROUND', 'citation': 'Redefer LA, Goodman JF. Brief report: pet-facilitated therapy with autistic children. 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Epub 2014 Oct 29.'}, {'pmid': '21241953', 'type': 'BACKGROUND', 'citation': 'Cummings JR, Druss BG. Racial/ethnic differences in mental health service use among adolescents with major depression. J Am Acad Child Adolesc Psychiatry. 2011 Feb;50(2):160-70. doi: 10.1016/j.jaac.2010.11.004. Epub 2010 Dec 31.'}, {'pmid': '20222125', 'type': 'BACKGROUND', 'citation': 'Smalley KB, Yancey CT, Warren JC, Naufel K, Ryan R, Pugh JL. Rural mental health and psychological treatment: a review for practitioners. J Clin Psychol. 2010 May;66(5):479-89. doi: 10.1002/jclp.20688.'}, {'pmid': '21408020', 'type': 'BACKGROUND', 'citation': 'Leiberg S, Klimecki O, Singer T. Short-term compassion training increases prosocial behavior in a newly developed prosocial game. PLoS One. 2011 Mar 9;6(3):e17798. doi: 10.1371/journal.pone.0017798.'}, {'pmid': '19321267', 'type': 'BACKGROUND', 'citation': 'Gunnar MR, Talge NM, Herrera A. Stressor paradigms in developmental studies: what does and does not work to produce mean increases in salivary cortisol. Psychoneuroendocrinology. 2009 Aug;34(7):953-67. doi: 10.1016/j.psyneuen.2009.02.010. Epub 2009 Mar 24.'}, {'pmid': '1941517', 'type': 'BACKGROUND', 'citation': 'Eisenberg N, Fabes RA, Schaller M, Miller P, Carlo G, Poulin R, Shea C, Shell R. Personality and socialization correlates of vicarious emotional responding. J Pers Soc Psychol. 1991 Sep;61(3):459-70.'}, {'pmid': '10477935', 'type': 'BACKGROUND', 'citation': 'Luby JL, Svrakic DM, McCallum K, Przybeck TR, Cloninger CR. The Junior Temperament and Character Inventory: preliminary validation of a child self-report measure. Psychol Rep. 1999 Jun;84(3 Pt 2):1127-38. doi: 10.2466/pr0.1999.84.3c.1127.'}, {'pmid': '19348541', 'type': 'BACKGROUND', 'citation': 'Sherman GD, Haidt J, Coan JA. Viewing cute images increases behavioral carefulness. Emotion. 2009 Apr;9(2):282-6. doi: 10.1037/a0014904.'}, {'pmid': '9829098', 'type': 'BACKGROUND', 'citation': 'Belli RF. The structure of autobiographical memory and the event history calendar: potential improvements in the quality of retrospective reports in surveys. Memory. 1998 Jul;6(4):383-406. doi: 10.1080/741942610.'}, {'pmid': '6668417', 'type': 'BACKGROUND', 'citation': 'Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "The objective of this study is to apply a rigorous experimental design to test whether children's interactions with therapy dogs increase immediate prosocial behavior and reduce immediate biological response to stress.", 'detailedDescription': "The central goal of the study is to determine whether brief interactions with a therapy dog have an immediate impact on children's biological response to stress, prosocial behaviors, and self-reported mood in comparison to interactions with a stuffed toy dog. The study uses a randomized crossover design with two study arms; all children will receive the both interventions during the same session, with the timing of the intervention randomized across subject. All outcomes will be assessed during a single study visit. No follow-up data will be collected.\n\nThe study uses both between-group and within-subject comparisons. Between groups, the investigators predict that children who interact with a therapy dog prior to a psychosocial stress task (Arm 1) will show attenuated cortisol response to the stress task (primary outcome) and reduced physiological stress (secondary outcomes) compared to children who interact with a stuffed toy dog prior to the psychosocial stress task (Arm 2). As an additional control, children will also watch a 5 minute puppy video prior to the prosocial stress task and will then interact with a stuffed toy dog prior to the psychosocial stress task (Arm 3).\n\nConversely, children who interact with the therapy dog immediately prior to the in-lab behavior tasks (Arm 2) will show higher levels of behavioral carefulness and prosocial behavior (primary outcomes) compared to children who interact with the stuffed toy dog prior to the behavior tasks (Arm 1).\n\nWithin subjects across both study arms, increases in positive mood and decreases in negative mood (secondary outcomes) will be greatest following interaction with the therapy dog compared to the stuffed toy dog, after controlling for main effects of study arm. Within subjects, physiological markers of stress (secondary outcomes) will be lower during the interaction with the therapy dog than during interaction with the stuffed toy dog.\n\nInvestigators will seek additional funds to collect and analyze salivary oxytocin data. The hypothesis is that children will show greater increase in oxytocin following interaction with the therapy dog in comparison to interaction with the stuffed toy dog.\n\nThis study will also investigate the mechanisms through which child-dog interactions influence youth stress responsivity, using coded videotaped data from the subset of children in Arm 1 who interact with the therapy dog prior to the psychosocial stress task. It is hypothesized that child behaviors observed during the interaction, such as duration and frequency of eye gaze, petting and stroking behaviors, and use of positive affect, will be inversely correlated with change in cortisol response to stress. Dog behaviors, such as duration and frequency of eye gaze and approach behaviors, will be inversely correlated with children's change in cortisol response to stress.\n\nThe study will also investigate whether child characteristics moderate the effects of the child-dog interaction. Investigators hypothesize that the effects of the therapy dog intervention will be stronger among children who currently live with dogs versus non-dog owning children and among children with more positive attitudes towards pets. It is also expected that the effects of the therapy dog interaction will be weaker among children with internalizing problems and for children experiencing higher levels of general stress. Investigators will also test whether the effects of the therapy dog intervention vary across child gender, race/ethnicity, or socioeconomic status, or child personality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Children between the ages of 8-12 years old\n\nExclusion Criteria:\n\n* Limited comprehension of English\n* Severe neurological, medical, or psychiatric illnesses (e.g., schizophrenia, psychosis)\n* Severe asthma or animal allergies\n* Animal phobias\n* Use of medications that affect cortisol'}, 'identificationModule': {'nctId': 'NCT03949569', 'briefTitle': 'The Effects of Therapy Dogs on Child Biology and Behavior', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'A Pilot Study of the Effects of Interactions With Therapy Dogs on Child Stress Responsivity', 'orgStudyIdInfo': {'id': 'IRB18-0472'}, 'secondaryIdInfos': [{'id': 'R21HD094956', 'link': 'https://reporter.nih.gov/quickSearch/R21HD094956', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'In this condition, children will interact with the therapy dog prior to the psychosocial stress task and with the stuffed toy dog prior to the prosocial behavior tests.', 'interventionNames': ['Behavioral: Therapy Dog', 'Behavioral: Stuffed Toy Dog']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'In this condition, children will interact with the stuffed toy prior to the psychosocial stress task collection and with the therapy dog prior to the prosocial behavior tests.', 'interventionNames': ['Behavioral: Therapy Dog', 'Behavioral: Stuffed Toy Dog']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'In this condition, children will watch a 5 minute puppy video prior to the psychosocial stress task collection and with the therapy dog prior to the prosocial behavior tests.', 'interventionNames': ['Behavioral: Stuffed Toy Dog', 'Behavioral: 5 Minute Puppy Video']}], 'interventions': [{'name': 'Therapy Dog', 'type': 'BEHAVIORAL', 'description': 'Children will undergo a 5 minute unstructured session with either a certified therapy dog or with a dog who is trained and certified for animal-assisted interventions and/or animal-assisted activities. Children will be allowed to talk to, pet, and play with the therapy dog during the interaction.', 'armGroupLabels': ['Arm 1', 'Arm 2']}, {'name': 'Stuffed Toy Dog', 'type': 'BEHAVIORAL', 'description': 'Children will undergo a 5 minute unstructured session with a stuffed toy dog. Children will be allowed to talk to, pet, and play with the stuffed toy dog during the interaction.', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}, {'name': '5 Minute Puppy Video', 'type': 'BEHAVIORAL', 'description': 'Children will watch a 5 minute puppy video.', 'armGroupLabels': ['Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Kristen C Jacobson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available beginning 6 months after publication and will be available for up to 5 years post-publication.', 'ipdSharing': 'YES', 'description': 'All IPD underlying research publications', 'accessCriteria': 'The PI will evaluate written requests for IPD sharing. All requests must be made from individuals with legitimate research questions and must be compliant with IRB regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-09-08', 'type': 'RELEASE'}, {'date': '2025-09-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Chicago'}}}}