Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-01-04 @ 2:54 AM
Study NCT ID:
NCT02543203
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2015-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Essential Oils for Enhancing QOL in ASD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jill.Hollway@osumc.edu', 'phone': '614-688-3848', 'title': 'Dr. Jill Ann Hollway', 'organization': 'The Ohio State University Nisonger Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants are systematically monitored for adverse events by study physicians (at all 10 visits). Vital signs, including resting BP, were evaluated at every visit as well.', 'description': 'According to all laboratory reports and physician review of adverse events potentially related to oil blend administration, there are no clinically significant abnormal values or adverse events. Recorded adverse events related to study treatment include minor events such as hyperactivity and intolerance to oil smell', 'eventGroups': [{'id': 'EG000', 'title': 'Reconnect', 'description': 'Subjects were randomized to treatment order in a cross-over study design. The adverse events noted below were recorded from subjects in the Reconnect group.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Coconut Oil Blend (Comparator)', 'description': 'Subjects were randomized to treatment order in a cross-over study design. The adverse events noted below were recorded from subjects in the coconut oil comparator group.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 23, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'URI', 'notes': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'URI'}, {'term': 'Increased Irritability', 'notes': 'Increased Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Irritability'}, {'term': 'Streptococcal pharyngitis,', 'notes': 'Streptococcal pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Streptococcal pharyn'}, {'term': 'Vomiting', 'notes': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Vomiting'}, {'term': 'Enuresis', 'notes': 'Enuresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Enuresis'}, {'term': 'Environmental Allergy', 'notes': 'Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Allergy'}, {'term': 'Tussis', 'notes': 'Tussis or cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Tussis'}, {'term': 'Fever', 'notes': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Fever'}, {'term': 'Gastroenteritis', 'notes': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Gastroenteritis'}, {'term': 'Gastrointestinal upset', 'notes': 'Gastrointestinal upset', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Gastrointestinal Ups'}, {'term': 'Increased Self Injury', 'notes': 'Increased Self Injury (biting self)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Increased Self injur'}, {'term': 'Otitis media', 'notes': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Otitis media'}, {'term': 'Rhinorrhea', 'notes': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Rhinorrhea'}, {'term': 'Sleep disturbance', 'notes': 'Sleep disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Sleep disturbance'}, {'term': 'Viral exanthem', 'notes': 'Exanthem rash or eruption on the skin due to virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Viral exanthem'}, {'term': 'Increase of verbal stemming', 'notes': 'Increase in verbal stemming (squealing)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Verbal stemming'}, {'term': 'Adverse reaction to noxious oil smell', 'notes': 'Noxious oil smell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Noxious oil smell'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pediatric Quality of Life Inventory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Received Re-Connect Then the Comparator Oil Blend', 'description': 'Subjects were randomized to order. Twelve subjects were randomized to Re-connect for the first 3-months, then after the one-month washout they received the coconut oil comparator during the last 3-months. The PedsQL was administered at screen, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment)'}, {'id': 'OG001', 'title': 'Subjects Revieved the Comparator Oil Blend and Then Re-Connnec', 'description': 'Subjects were randomized to treatment order. Fourteen subjects received the comparator oil blend for the first 3-months, then after the one-month washout they received Re-connect (last 3-months).The PedsQL was administered at screen, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment)'}], 'classes': [{'title': 'Baseline Means', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.5', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '56.2', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6 Means', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.5', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '65.3', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Visit 10 Means', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.3', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '66.6', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 Weeks', 'description': "Pediatric Quality of Life Inventory (PedsQL) (Varni, Burwinkle, \\& Seid, 2006). The Generic PedsQL Inventory is a caregiver-rated scale for children ages 2-12. The PedsQL Inventory for 2-4 year old children includes 21 items. The PedsQL Inventories for 5-12 year old children include 23-items. The PedsQL Inventories were designed to measure the core domains of health and their impact on the quality of life in children as outlined by the World Health Organization. The four sub-scales are Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. The summary scores include a total scale score and individual sub-scale scores. Higher scores on reversed scored items indicates better quality of life.The scores when reversed range from 0 to 100.Since there were an unequal number of items on the younger children's inventory, to be enrolled we used a cut-off of \\> or = 1.5 item mean on the PedsQL Inventory, which indicated poorer quality of life.", 'unitOfMeasure': 'Total Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Early terminations occurred throughout the study. Described in study flow table.'}, {'type': 'SECONDARY', 'title': "Children's Sleep Habits Questionnaire", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Received Re-Connect Then the Comparator Oil Blend', 'description': 'Subjects were randomized to treatment order. Twelve subjects received Re-connect for the first 3-months, then after the one-month washout they received the comparator oil blend (last 3-months).The CSHQ was administered at all visits including the Screen Visit, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment).'}, {'id': 'OG001', 'title': 'Subjects Received the Comparator Oil Blend and Then Re-connnec', 'description': 'Subjects were randomized to treatment order. Fourteen subjects received the comparator oil blend for the first 3-months, then after the one-month washout they received Re-connect (last 3-months).The CSHQ was administered at all visits including the Screen Visit, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment).'}], 'classes': [{'title': 'Baseline Means', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.3', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '49.7', 'spread': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6 Means', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.6', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '43.1', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Visit 10 Means', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.0', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '44.5', 'spread': '7.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 Weeks', 'description': "Children's Sleep Habits Questionnaire (CSHQ) (Owens, Spirito, \\& Mcguinn, 2000). The abbreviated CSHQ is a valid measure of sleep problems with good psychometric properties. It includes 33 items and is rated retrospectively over the previous week by parents to screen for the most common sleep problems. The Abbreviated CSHQ 33 items include eight key sleep domains. The eight subscales include: (1) bedtime resistance (2) sleep onset latency, (3) sleep duration, (4) anxiety around sleep, (5) night awakenings, (6) sleep disordered breathing, (7) parasomnias and (8) morning waking/daytime sleepiness. The 33 items are summed to get a total sleep disturbance score. A total sleep disturbance score of 41 or greater for the CSHQ's 33 items has been reported to be an appropriate clinical cut-off for identifying sleep disturbance in children. Responses range from 0 to 3 with a total range of 0 to 99 for all 33 items and higher scores indicate more sleep disturbance.", 'unitOfMeasure': 'Sleep Disturbance Total Score of 33 item', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Early terminations occurred through out the study. See the Study flow table.'}, {'type': 'SECONDARY', 'title': 'Parent-rated Anxiety Scale for Autism Spectrum Disorder PRAS-ASD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Received Re-Connect Then the Comparator Oil Blend', 'description': 'Subjects were randomized to treatment order. Twelve subjects received Re-connect for the first 3-months, then after the one-month washout they received the comparator oil blend (last 3-months).The PRAS-ASD was administered at all visits including the Screen Visit, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment).'}, {'id': 'OG001', 'title': 'Subjects Revieved the Comparator Oil Blend and Then Re-Connnec', 'description': 'Subjects were randomized to treatment order. Fourteen subjects received the comparator oil blend for the first 3-months, then after the one-month washout they received the comparator oil blend (last 3-months).The PRAS-ASD was administered at all visits including the Screen Visit, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment).'}], 'classes': [{'title': 'Baseline Means', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.6', 'spread': '15.45', 'groupId': 'OG000'}, {'value': '31.7', 'spread': '10.1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6 Means', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '14.6', 'groupId': 'OG001'}]}]}, {'title': 'Visit 10 Means', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '13.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 Weeks', 'description': 'The PRAS-ASD (Scahill et al., 2019), is a parent-rated scale used to measure anxiety in children with autism spectrum disorder. The 25 items on the PRAS-ASD each range from 0 to 3 with a possible total of 75. Higher scores indication more anxiety.', 'unitOfMeasure': 'Total Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Early terminations occurred throughout the study. See the study flow table.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Developmental Disabilities - Children's Global Assessment Scale (DD=CGAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Received Re-connect Then the Comparator Oil Blend', 'description': 'Subjects were randomized to treatment order. Twelve subjects received Re-connect for the first 3-months, then after the one-month washout they received the comparator oil blend during the last 3-months.The DDCGAS was administered at the Baseline Visit, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment).'}, {'id': 'OG001', 'title': 'Subjects Received the Comparator Oil Blend and Then Re-connnec', 'description': 'Subjects were randomized to treatment order. Fourteen subjects received the comparator oil blend for the first 3-months, then after the one-month washout they received the comparator oil blend during the last 3-months.The DDCGAS was administered at the Baseline Visit, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment).'}], 'classes': [{'title': 'Baseline Means', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.8', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '52.6', 'spread': '12.7', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6 Means', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.9', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '55.6', 'spread': '13.5', 'groupId': 'OG001'}]}]}, {'title': 'Visit 10 Means', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.4', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '62.8', 'spread': '8.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 Weeks', 'description': 'Developmental Disabilities - Children\'s Global Assessment Scale (DD-CGAS) (Wagner et al., 2007). The clinician-rated DD-CGAS measures global functioning in children with developmental disorders in treatment studies. The DD-CGAS was used to characterize impairment in the following four domains: Self Care, Communication, Social Behavior, and School/Academic. In addition, this scale also includes a series of descriptive "bands" to characterize global functioning in children with pervasive developmental disorders from "extreme and pervasive impairment" through "superior functioning." Scores range fro 1 to 100 and higher scores on the DD-CGAS indicate increased independence of daily functioning.', 'unitOfMeasure': 'Clinician Global Rating', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Early terminations occurred throughout the study. See the study flow table.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Received Re-connect Then the Comparator Oil Blend', 'description': 'Subjects were randomized to treatment order. Twelve subjects received Re-connect for the first 3-months, then after the one-month washout they received the comparator oil blend during the last 3-months.Adverse events were queried by the study physician at all study visits. Safety population included all participants who received one dose of study IP.'}, {'id': 'OG001', 'title': 'Subjects Received the Comparator Oil Blend and Then RE-connect', 'description': 'Subjects were randomized to treatment order. Fourteen subjects received the comparator oil blend for the first 3-months, then after the one-month washout they received Re-connect during the last 3-months. Adverse events were queried by the study physician at all study visits.'}], 'classes': [{'title': 'Visit 6', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Visit 10', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 Weeks', 'description': "Adverse Events (AEs). To minimize the risk, subjects will be systematically monitored. AEs, vital signs, including resting BP, will be evaluated at each visit throughout all phases of the study. When the treating clinician elicits an AE, it will be documented on a case report form, regardless of suspected relationship to the essential oil. For all AEs, the investigator will obtain sufficient information to determine the onset, course, and outcome of the AE. If a subject has experienced an AE, the subject may return to the site for an unscheduled visit at the PI's discretion. If any of these AEs are serious and/or unexpected, the site PI will contact the Sponsor and notify the IRB as appropriate.\n\nPotential AEs include sun sensitivity due to the Bergamot in the essential oil, possibly gynecomastia in pre-pubescent males due to the lavender oil in the essential oil, and skin irritation at the application site.", 'unitOfMeasure': 'total number of events per condition', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Reconnect, Then Comparator', 'description': 'Participants received Reconnect each morning and evening for 3-months and then after a 1-month washout they received the comparator oil. In the morning the oil was administered topically. Participants were administered 1 drop to the back of the neck and 1 drop to the feet, to be rubbed in for 30 seconds to 1 minute.\n\nIn the evening, before bedtime, the aromatic method was used. Caregivers diffused 8-12 drops of oil in water at night.'}, {'id': 'FG001', 'title': 'Coconut Oil Comparator, Then Reconnect', 'description': 'Participants received the comparator oil each morning and evening for 3-months and then after a 1-month washout they received Reconnect. In the morning the oil was administered topically. Participants were administered 1 drop to the back of the neck and 1 drop to the feet, to be rubbed in for 30 seconds to 1 minute.\n\nIn the evening, before bedtime, the aromatic method was used. Caregivers diffused 8-12 drops of oil in water at night.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Unpalatable Fragrance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Increased Irritability', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Family', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Negative Behavior', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "Forty subjects were screened for eligibility between between July 22nd 2015 and June 22nd 2017, at the Ohio State University's Nisonger Center.", 'preAssignmentDetails': "Of the 40 subjects screened, 28 were randomized to treatment order. Twelve subjects did not meet the study criteria. After randomization, one subject's caregiver revealed that she could not stop melatonin treatment and another caregiver withdrew because there was a death in the family. The modified intent to treat sample included 26 participants."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'A/C (Reconnect/Comparator)', 'description': 'Topical: Apply 1 drop to the back of the neck and 1 drop to the feet. Rub in the oil for 30 seconds to 1 minute. Each bottle has an orifice that allows the oil to be expelled drop by drop. Dilution is not required, except for the most sensitive skin. Apply in the morning.\n\nAromatic Method: Diffuse one diffuser-full (8-12 drops of oil in water) at night.'}, {'id': 'BG001', 'title': 'C/A (Comparator/Reconnect)', 'description': 'Topical: Apply 1 drop to the back of the neck and 1 drop to the feet. Rub in the oil for 30 seconds to 1 minute. Each bottle has an orifice that allows the oil to be expelled drop by drop. Dilution is not required, except for the most sensitive skin. Apply in the morning.\n\nAromatic Method: Diffuse one diffuser-full (8-12 drops of oil in water) at night.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Children's Sleep Habits Questionnaire (CSHQ)", 'classes': [{'categories': [{'measurements': [{'value': '54.25', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '66'}, {'value': '49.71', 'groupId': 'BG001', 'lowerLimit': '33', 'upperLimit': '72'}, {'value': '51.98', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '72'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale 0 to 99 higher worse', 'dispersionType': 'FULL_RANGE'}, {'title': 'Parent-rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD)', 'classes': [{'categories': [{'measurements': [{'value': '32.58', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '61'}, {'value': '31.71', 'groupId': 'BG001', 'lowerLimit': '17', 'upperLimit': '48'}, {'value': '32.15', 'groupId': 'BG002', 'lowerLimit': '6', 'upperLimit': '61'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale 0 to 75 higher worse', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Twenty eight subjects were randomized but 2 terminated after the Baseline visit and the data analyzed was an MITT sample of 26 participant who had data for at least one other study visit from Baseline.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-03', 'size': 532086, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-29T14:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-03', 'studyFirstSubmitDate': '2015-08-17', 'resultsFirstSubmitDate': '2019-04-30', 'studyFirstSubmitQcDate': '2015-09-04', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-03', 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Developmental Disabilities - Children's Global Assessment Scale (DD=CGAS)", 'timeFrame': '28 Weeks', 'description': 'Developmental Disabilities - Children\'s Global Assessment Scale (DD-CGAS) (Wagner et al., 2007). The clinician-rated DD-CGAS measures global functioning in children with developmental disorders in treatment studies. The DD-CGAS was used to characterize impairment in the following four domains: Self Care, Communication, Social Behavior, and School/Academic. In addition, this scale also includes a series of descriptive "bands" to characterize global functioning in children with pervasive developmental disorders from "extreme and pervasive impairment" through "superior functioning." Scores range fro 1 to 100 and higher scores on the DD-CGAS indicate increased independence of daily functioning.'}, {'measure': 'Adverse Events', 'timeFrame': '28 Weeks', 'description': "Adverse Events (AEs). To minimize the risk, subjects will be systematically monitored. AEs, vital signs, including resting BP, will be evaluated at each visit throughout all phases of the study. When the treating clinician elicits an AE, it will be documented on a case report form, regardless of suspected relationship to the essential oil. For all AEs, the investigator will obtain sufficient information to determine the onset, course, and outcome of the AE. If a subject has experienced an AE, the subject may return to the site for an unscheduled visit at the PI's discretion. If any of these AEs are serious and/or unexpected, the site PI will contact the Sponsor and notify the IRB as appropriate.\n\nPotential AEs include sun sensitivity due to the Bergamot in the essential oil, possibly gynecomastia in pre-pubescent males due to the lavender oil in the essential oil, and skin irritation at the application site."}], 'primaryOutcomes': [{'measure': 'Pediatric Quality of Life Inventory', 'timeFrame': '28 Weeks', 'description': "Pediatric Quality of Life Inventory (PedsQL) (Varni, Burwinkle, \\& Seid, 2006). The Generic PedsQL Inventory is a caregiver-rated scale for children ages 2-12. The PedsQL Inventory for 2-4 year old children includes 21 items. The PedsQL Inventories for 5-12 year old children include 23-items. The PedsQL Inventories were designed to measure the core domains of health and their impact on the quality of life in children as outlined by the World Health Organization. The four sub-scales are Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. The summary scores include a total scale score and individual sub-scale scores. Higher scores on reversed scored items indicates better quality of life.The scores when reversed range from 0 to 100.Since there were an unequal number of items on the younger children's inventory, to be enrolled we used a cut-off of \\> or = 1.5 item mean on the PedsQL Inventory, which indicated poorer quality of life."}], 'secondaryOutcomes': [{'measure': "Children's Sleep Habits Questionnaire", 'timeFrame': '28 Weeks', 'description': "Children's Sleep Habits Questionnaire (CSHQ) (Owens, Spirito, \\& Mcguinn, 2000). The abbreviated CSHQ is a valid measure of sleep problems with good psychometric properties. It includes 33 items and is rated retrospectively over the previous week by parents to screen for the most common sleep problems. The Abbreviated CSHQ 33 items include eight key sleep domains. The eight subscales include: (1) bedtime resistance (2) sleep onset latency, (3) sleep duration, (4) anxiety around sleep, (5) night awakenings, (6) sleep disordered breathing, (7) parasomnias and (8) morning waking/daytime sleepiness. The 33 items are summed to get a total sleep disturbance score. A total sleep disturbance score of 41 or greater for the CSHQ's 33 items has been reported to be an appropriate clinical cut-off for identifying sleep disturbance in children. Responses range from 0 to 3 with a total range of 0 to 99 for all 33 items and higher scores indicate more sleep disturbance."}, {'measure': 'Parent-rated Anxiety Scale for Autism Spectrum Disorder PRAS-ASD', 'timeFrame': '28 Weeks', 'description': 'The PRAS-ASD (Scahill et al., 2019), is a parent-rated scale used to measure anxiety in children with autism spectrum disorder. The 25 items on the PRAS-ASD each range from 0 to 3 with a possible total of 75. Higher scores indication more anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relaxation'], 'conditions': ['Autism Spectrum Disorder', 'Quality of Life', 'Sleep', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'Essential oils (aromatic oils extracted from plant parts) are routinely used by the public and are available on the market. Investigators are conducting this study because it is unknown whether the essential oils formulations will be safe and effective for improving quality of life in children with Autism Spectrum Disorder (ASD) by helping them relax and sleep.\n\nChildren invited to participate in this study must be between 3-9 years of age and have been diagnosed with Autism Spectrum Disorder. Twenty eight children and their families will be enrolled in the study.\n\nParticipants will try two different fragrant oils in a double-blind randomized order. Each child will receive each treatment for 3 months, with a 1-month "washout" period in between during which no oil is used.', 'detailedDescription': 'The purpose of the study is to evaluate the use of two fragrant oil formulations to enhance quality of life by increasing relaxation and sleep quality in children with Autism Spectrum Disorder (ASD). Essential oils (aromatic oils extracted from plant parts) are routinely used by the public and are available on the market. Investigators are conducting this study because it is unknown whether the essential oils formulations will be safe and effective for helping children with ASD relax and sleep.\n\nTo participate in this study children must be between 3-9 years of age and have been diagnosed with Autism Spectrum Disorder. Approximately 40 children will be screened to enroll 28 children and their families in the study.\n\nIn a double-blind crossover study, participants will be randomized to treatment order. All participants will receive both fragrant oil blends. Those randomized will receive one fragrant oil blend for 3 months, with a 1-month "washout" period in between and then start the second fragrant oil blend in the last 3 months. The treatment orders are A/C and C/A.\n\nStudy participation will last for 7 months. There will be one screening visit (about 5 hours long, which can be split into 2 visits), two baseline visits (about 2 hours each), two endpoint visits (2 hours each) and 5 other clinic visits (each 45-60 minutes). Visits will take place at the OSU Nisonger Center and the OSU General Clinical Research Center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients between 3 and 9 years of age, inclusive;\n* Diagnosis of Autism Spectrum Disorder (ASD) by DSM-V;\n* Mean item score of \\> or = 1.5 PedsQL Inventory;\n* Care provider who can reliably bring subject to clinic visits and provide trustworthy ratings.\n\nExclusion Criteria:\n\n* Bipolar disorder by Child \\& Adolescent Symptom Inventory (CASI, Gadow \\& Sprafkin, 1997) and clinical interview/history, or major depression accompanied by family history of bipolar disorder;\n* Children with allergies to essential oils;\n* Children with seizure disorder/epilepsy;\n* Significant physical illness (e.g., serious cardiovascular, liver or renal pathology);\n* Medications specifically given for insomnia and exogenous melatonin, which have the potential to confound study results, within the previous 2 weeks before baseline;\n* Anticipated changes of doses of medication or other medical treatments or supplements;\n* Weight less than 10 kg;\n* Sleep Disordered Breathing (SDB) as defined by a total score of \\> or = 3 on the CSHQ SDB subscale and parent report;\n* Nut allergies;\n* Allergy to vanilla;\n* A substantial trial of essential oil use within the past 6 months (i.e., consistent use for 6 weeks).'}, 'identificationModule': {'nctId': 'NCT02543203', 'briefTitle': 'Essential Oils for Enhancing QOL in ASD', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Essential Oils for Enhancing of Quality of Life in Autism Spectrum Disorder (ASD)', 'orgStudyIdInfo': {'id': '2015H0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A/C - Reconnect, Then Coconut Oil Comparator', 'description': 'Participants randomized to treatment order A/C, received Reconnect for 3-months each day, morning and evening. After a washout period of one-month, they received the Coconut Oil Comparator morning and evening for 3-months.\n\nAM: Children received a topical application of one drop of oil to the back of the neck and 1 drop to the feet.\n\nPM: Children received the oil blend by the aromatic method as it was diffused throughout their bedrooms while they slept. Each bottle has an orifice that allows the oil to be expelled drop by drop the evening dose was 8-12 drops added to the diffuser.', 'interventionNames': ['Biological: Reconnect', 'Biological: Coconut oil Comparator']}, {'type': 'SHAM_COMPARATOR', 'label': 'C/A - Coconut oil Blend, Then Reconnect', 'description': 'Participants randomized to treatment order C/A received the Coconut Oil Comparator for 3-months each day, morning and evening. After a washout period of one-month, they received Reconnect morning and evening for 3-months.\n\nAM: Children received a topical application of one drop of oil to the back of the neck and 1 drop to the feet.\n\nPM: Children received the oil blend by the aromatic method as it was diffused throughout their bedrooms while they slept. Each bottle has an orifice that allows the oil to be expelled drop by drop the evening dose was 8-12 drops added to the diffuser.', 'interventionNames': ['Biological: Reconnect', 'Biological: Coconut oil Comparator']}], 'interventions': [{'name': 'Reconnect', 'type': 'BIOLOGICAL', 'description': 'Topical Essential Oils mixture and aromatic method', 'armGroupLabels': ['A/C - Reconnect, Then Coconut Oil Comparator', 'C/A - Coconut oil Blend, Then Reconnect']}, {'name': 'Coconut oil Comparator', 'type': 'BIOLOGICAL', 'description': 'Topical Essential Oils mixture and aromatic method', 'armGroupLabels': ['A/C - Reconnect, Then Coconut Oil Comparator', 'C/A - Coconut oil Blend, Then Reconnect']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Nisonger Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Jill A Hollway, Ph.D., M.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University, Nisonger Center UCEDD'}, {'name': 'Eugene Arnold, M.D.,M.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University, Nisonger Center UCEDD'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': '12/30/2019', 'ipdSharing': 'YES', 'description': 'We will upload de-identified raw data.', 'accessCriteria': 'Raw data in PDF archive and study report'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jill Hollway', 'class': 'OTHER'}, 'collaborators': [{'name': 'Young Living Essential Oils', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Scientist and Assistant Professor, Research Psychiatry', 'investigatorFullName': 'Jill Hollway', 'investigatorAffiliation': 'Ohio State University'}}}}