Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-01 @ 6:58 AM
Study NCT ID:
NCT03369769
Status:
COMPLETED
Last Update Posted:
2019-05-20
First Post:
2017-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wellness Effects of Animal-assisted Activities With Autism Spectrum Disorder Youth in a Specialized Psychiatric Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002652', 'term': 'Child Behavior'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Coders for the videotaped behavioral data collected via the OHAIRE-M tool were blind to specific study objective.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'To investigate the effect of canine animal assisted activities (AAA) on physiological arousal levels in children and adolescents with autism spectrum disorder (ASD) (ages 4 to 17 years) in a specialized psychiatric hospital program. It is hypothesized that children with ASD will demonstrate lower physiological arousal in the presence of canines, compared to a non-animal control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-16', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-12-06', 'lastUpdatePostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in physiological measurements with the wristband device from baseline through 90 minutes.', 'timeFrame': 'Baseline; 90 minutes', 'description': 'The Wristband device is worn by the participant for 90 minutes during the day of the experimental condition. Physiological measure of Galvanic skin response, heart rate, heart rate variability will be assessed at baseline through 90 minutes. Collection points during this day includes comparison from baseline, social group, and experimental condition.'}], 'secondaryOutcomes': [{'measure': 'Observation of Human Animal Interaction for Research (OHAIRE-modified)', 'timeFrame': 'Two 10-minute conditions (experimental and control) on two separate days.', 'description': 'The Observation of Human-Animal Interaction for Research (OHAIRE) is a timed interval coding system intended to capture the unique interactions between humans and animals. It was originally developed and piloted with children with autism spectrum disorder (ASD) interacting with typically-developing peers in a small group school setting with guinea pigs compared to toys.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Behavior', 'Autism Spectrum Disorder', 'Psychiatric Hospitalization', 'Veterinary Therapeutics']}, 'referencesModule': {'references': [{'pmid': '30818971', 'type': 'BACKGROUND', 'citation': "Germone MM, Gabriels RL, Guerin NA, Pan Z, Banks T, O'Haire ME. Animal-assisted activity improves social behaviors in psychiatrically hospitalized youth with autism. Autism. 2019 Oct;23(7):1740-1751. doi: 10.1177/1362361319827411. Epub 2019 Feb 28."}]}, 'descriptionModule': {'briefSummary': 'Background: Children with Autism Spectrum Disorder (ASD) are at higher risk for developing co-existing mental health conditions and consequently experiencing psychiatric hospitalization, compared to the general pediatric population. However, hospital environments can be exceptionally stressful for this population, given their social-communication deficits, ineffective emotional regulation skills and heightened physiological arousal. While the use of animal-assisted activities (AAA) show potential for various improvements in children with ASD in community settings, these "stress-reducing" and "social-buffering" benefits have not yet been studied within a psychiatric hospital setting for youth with ASD.\n\nObjectives: Evaluate whether an AAA with canines can lead to reduced physiological arousal and improvements in social-communication as well as aberrant behaviors in children and adolescents diagnosed with ASD in a specialized psychiatric hospital setting.\n\nMethods: Participants were recruited from the Neuropsychiatric Special Care (NSC) program\'s inpatient and/or partial day-treatment program. Prior to study participation, baseline demographic measures were acquired from caregivers and participants\' ASD diagnosis was confirmed. Participants experienced two, randomly assigned 35-minute sessions (AAA and Control Condition) with a minimum two-day washout period between groups. Each session included a baseline 20-minute social skills group immediately followed by a 10 minute experimental or control condition. The AAA condition introduced a canine and volunteer handler for free interaction time while the control condition introduced a novel toy and a volunteer for free interaction. Participants\' physiological arousal was continuously assessed throughout all conditions via the Empatica E-4 wristbands (Empatica Inc. 2014). All sessions were videotaped for behavioral coding using the Observation of Human Animal Interaction for Research - Modified, v.1.', 'detailedDescription': 'Background: Children with ASD are at higher risk for developing co-existing mental health conditions and consequently experiencing psychiatric hospitalization, compared to the general pediatric population. However, hospital environments can be exceptionally stressful for this population, given their social-communication deficits, ineffective emotional regulation skills and heightened physiological arousal. While the use of animal-assisted activities (AAA) show potential for various improvements in children with ASD in community settings, these "stress-reducing" and "social-buffering" benefits have not yet been studied within a psychiatric hospital setting for youth with ASD.\n\nObjectives: Evaluate whether an AAA with canines can lead to reduced physiological arousal and improvements in social-communication as well as aberrant behaviors in children and adolescents diagnosed with ASD in a specialized psychiatric hospital setting.\n\nMethods: Participants were recruited from the Neuropsychiatric Special Care (NSC) program\'s inpatient and/or partial day-treatment program. Prior to study participation, baseline demographic measures were acquired from caregivers and participants\' ASD diagnosis was confirmed. Participants experienced two, randomly assigned 35-minute sessions (AAA and Control Condition) with a minimum two-day washout period between groups. Each session included a baseline 20-minute social skills group immediately followed by a 10 minute experimental or control condition. The AAA condition introduced a canine and volunteer handler for free interaction time while the control condition introduced a novel toy and a volunteer for free interaction. Participants\' physiological arousal was continuously assessed throughout all conditions via the Empatica E-4 wristbands (Empatica Inc. 2014). All sessions were videotaped for behavioral coding using the Observation of Human Animal Interaction for Research - Modified, v.1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to a specialized psychiatric unit for children with developmental disabilities\n* Meeting standard cut-off scores for ASD on the Social Communication Questionnaire Screener (\\> 12) and Autism Diagnostic Observation Schedule-2nd Ed\n* English speaking\n\nExclusion Criteria:\n\n* Unwillingness to wear wristband \\& be videotaped\n* Allergies or phobias to canines\n* Inability to attend to and participate in a social group\n* Prisoner status or ward of the state'}, 'identificationModule': {'nctId': 'NCT03369769', 'briefTitle': 'Wellness Effects of Animal-assisted Activities With Autism Spectrum Disorder Youth in a Specialized Psychiatric Hospital', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Physiological Wellness Effects of Animal-assisted Activities in Children With Autism Spectrum Disorder in a Specialized Psychiatric Hospital Program', 'orgStudyIdInfo': {'id': '15-1227'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canine & Adult Handler Activity', 'description': 'Unstructured 10-minute small group interaction with canine \\& handler', 'interventionNames': ['Other: Activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Toy and Adult Handler Activity', 'description': 'Unstructured 10-minute small group interaction with toy \\& handler', 'interventionNames': ['Other: Activity']}], 'interventions': [{'name': 'Activity', 'type': 'OTHER', 'otherNames': ['animal-assisted activity (AAA)'], 'description': '10 minutes interaction with therapy dog and adult handler in small group (2-4 participants).', 'armGroupLabels': ['Canine & Adult Handler Activity', 'Toy and Adult Handler Activity']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robin L Gabriels, Psy.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Human Animal Bond Institute for Research', 'class': 'UNKNOWN'}, {'name': 'Purdue University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}