Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-06 @ 6:03 PM
Study NCT ID:
NCT00467818
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2007-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D000374', 'term': 'Aggression'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novotnsl@rutgers.edu', 'phone': '(732) 235-4119', 'title': 'Sherie Novotny MD', 'organization': 'UMDNJ'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'One subject had a recurrence of a psychiatric issue ( although might be unrelated to the intake of the placebo which he was on) which lead to hospitalisation and discontinuation of taking the placebo and subsequent withdrawal from the study.'}}, 'adverseEventsModule': {'timeFrame': 'The adverse event data were collected over the course of the study from the start in 2007 until completion in 2011. Each participant was observed for adverse events during the course of their treatment which was the course of the study, ie 12 weeks. Participants were not monitored for adverse events after the completion of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Omega 3 Fatty Acids, Drug', 'description': 'Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.\n\nOmega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'The placebo will be dispensed to subjects in the control group\n\nPlacebo : Same dosage as that of omega 3 fatty acids', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Recurrence of mood disorder in one participant', 'notes': 'One subject had a recurrence of a psychiatric issue ( although might be unrelated to the intake of the placebo which he was on) which lead to hospitalization and discontinuation of taking the placebo and subsequent withdrawal from the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Global Impression Scale(CGI)- Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega 3 Fatty Acids, Drug', 'description': 'Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.\n\nOmega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The placebo will be dispensed to subjects in the control group\n\nPlacebo : Same dosage as that of omega 3 fatty acids'}], 'classes': [{'categories': [{'measurements': [{'value': '3.57', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Administered biweekly, endpoint score (week 12) only used for data analysis', 'description': 'This scale measures the impression of improvement as assessed from interviewing the subject and informant.The scale is measured with numbers from 0 through 7 with 0 not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Units = scores on a scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Aberrant Behavior Checklist (ABC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega 3 Fatty Acids, Drug', 'description': 'Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.\n\nOmega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The placebo will be dispensed to subjects in the control group\n\nPlacebo : Same dosage as that of omega 3 fatty acids'}], 'classes': [{'categories': [{'measurements': [{'value': '5.66', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported', 'description': 'Aberrant Behavior Checklist (ABC)-Community Version (Irritability Subscale) (Aman et al. 1985). It is designed to objectively identify five behavior subscales through observation by the primary caregiver. The five behavior subscales include (ranges show no problem to severe problem): irritability (range 0-45), lethargy (range 0-48), stereotypy (range 0-21), hyperactivity range 0-48), and inappropriate speech (range 0-12), all possible signs and symptoms of affective instability in autistic individuals (Lainhart \\& Folstein, 1994). Improvement is shown with scores decreasing over time. Total score is not used. Inter-rater reliability for the ABC-CV is moderate to high across subscales with a mean of .63. Test-retest reliability correlations are .98 -Irritability, .99 -Lethargy, .98 -Stereotypy, .98 -Hyperactivity, and .96 -Inappropriate Speech. The ABC will be filled out by an informant (teacher/parent), and then reviewed by the IE. Administration time is approximately 10 minutes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Youth and adolescents ages 5-17 with autism spectrum disorder'}, {'type': 'PRIMARY', 'title': 'Vineland Adaptive Behavior Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega 3 Fatty Acids, Drug', 'description': 'Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.\n\nOmega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The placebo will be dispensed to subjects in the control group\n\nPlacebo : Same dosage as that of omega 3 fatty acids'}], 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'spread': '13.28', 'groupId': 'OG000'}, {'value': '27.5', 'spread': '9.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Administered during the baseline visit and on week 12 ( termination)', 'description': "The Vineland Scale is a semi-structured informant interview that assesses subjects' functioning. It is administered to a caretaker/family member. The scale has been revised and standardized in all populations. This scale has been found to assess social deficits in autism and strengths in daily living skills. Items are classified under four major adaptive domains: communication, daily living skills, socialization and motor skills. The items are scored 0-2 (yes/sometimes/never). Each domain is summed, and the domain scores are converted to standardized scores. The normative score is 100, with standard deviation of 15. The standardized score is used in this study. A higher score (above 100) means better adaptive behavior. Minimum value is 0, maximum value is infinity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overt Aggression Scale-Modified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega 3 Fatty Acids, Drug', 'description': 'Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.\n\nOmega 3 fatty acids: The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The placebo will be dispensed to subjects in the control group\n\nPlacebo: Same dosage as that of omega 3 fatty acids'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.5', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.50', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Administered biweekly and at week 12 (termination)', 'description': 'The Modified version, Coccaro et al. is designed for outpatient use and assessment of behavior over one week. This scale was assessed biweekly. The OAS-M consists of 3 domains: Aggression, Irritability, and Suicidality (not used). Aggression Domain: 4 subscales of weighted behavior: Verbal Aggression (1), Aggression Against Objects (2), Aggression Against Others (3), and Self-Aggression (4). Within each category, severity of an event receives a scaled score (0-5) (higher score for worse behaviors) which is then multiplied by the weekly frequency of this event and weight, then totaled (for use in this study). Irritability subscale is divided into subjective/objective, 0 (low)-5 (high). The total scale has a minimum value of 0 (no display of aggressive/irritable behavior) and a maximum value of infinity (worse aggressive/irritable behavior) as reporting the number of times an aggressive/irritable behavior occurred does not have a maximum value). Higher scores mean worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parental Stress Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega 3 Fatty Acids, Drug', 'description': 'Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.\n\nOmega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The placebo will be dispensed to subjects in the control group\n\nPlacebo : Same dosage as that of omega 3 fatty acids'}], 'classes': [{'categories': [{'measurements': [{'value': '314.2', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '279.5', 'spread': '35.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Administered during the baseline visit and on week 12 ( termination)', 'description': "This measurement assesses child and parental characteristics and parent-child relationship dimensions associated with the presence of parenting stress/ troubled relationships. It is a self-report scale completed by the parent, consisting of 101 items organized into two domains with the following subscales: (1) child characteristics domain - adaptability, demandingness, mood, distractibility/hyperactivity, acceptability of child to parent, and child's reinforcement of parent, and (2) parent characteristics domain - depression, attachment to child, social isolation, sense of competence in the parenting role, relationship with spouse/parenting partner, role restrictions, and parental health. Scores are 1-5 with 1 being strongly agree and 5 being strongly disagree. Scores are collected and standardized. The higher a score is, the more stress a parent is experiencing. Minimum value is 101 and maximum value is 505.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omega 3 Fatty Acids, Drug', 'description': 'Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.\n\nOmega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'The placebo will be dispensed to subjects in the control group\n\nPlacebo : Same dosage as that of omega 3 fatty acids'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruitment was difficult for this study due to multiple disruptions in the flow of the study due to issues with the IRB process. Additionally, there were periods of time when there was not a research coordinator to assist with recruitment and pt flow.', 'preAssignmentDetails': 'Participants were required to undergo diagnostic testing and intelligence testing prior to starting the study. Individuals who were unable to participate in these processes were not allowed to enter into the active phase of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Omega 3 Fatty Acids, Drug', 'description': 'Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.\n\nOmega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'The placebo will be dispensed to subjects in the control group\n\nPlacebo : Same dosage as that of omega 3 fatty acids'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '10.6', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '11.2', 'spread': '3.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-07', 'studyFirstSubmitDate': '2007-04-27', 'resultsFirstSubmitDate': '2013-10-25', 'studyFirstSubmitQcDate': '2007-04-30', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-19', 'studyFirstPostDateStruct': {'date': '2007-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Global Impression Scale(CGI)- Improvement', 'timeFrame': 'Administered biweekly, endpoint score (week 12) only used for data analysis', 'description': 'This scale measures the impression of improvement as assessed from interviewing the subject and informant.The scale is measured with numbers from 0 through 7 with 0 not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Units = scores on a scale.'}, {'measure': 'Aberrant Behavior Checklist (ABC)', 'timeFrame': 'Administered every 4 weeks, 12 week scores used for means, score on irritability subscale reported', 'description': 'Aberrant Behavior Checklist (ABC)-Community Version (Irritability Subscale) (Aman et al. 1985). It is designed to objectively identify five behavior subscales through observation by the primary caregiver. The five behavior subscales include (ranges show no problem to severe problem): irritability (range 0-45), lethargy (range 0-48), stereotypy (range 0-21), hyperactivity range 0-48), and inappropriate speech (range 0-12), all possible signs and symptoms of affective instability in autistic individuals (Lainhart \\& Folstein, 1994). Improvement is shown with scores decreasing over time. Total score is not used. Inter-rater reliability for the ABC-CV is moderate to high across subscales with a mean of .63. Test-retest reliability correlations are .98 -Irritability, .99 -Lethargy, .98 -Stereotypy, .98 -Hyperactivity, and .96 -Inappropriate Speech. The ABC will be filled out by an informant (teacher/parent), and then reviewed by the IE. Administration time is approximately 10 minutes.'}, {'measure': 'Vineland Adaptive Behavior Scale', 'timeFrame': 'Administered during the baseline visit and on week 12 ( termination)', 'description': "The Vineland Scale is a semi-structured informant interview that assesses subjects' functioning. It is administered to a caretaker/family member. The scale has been revised and standardized in all populations. This scale has been found to assess social deficits in autism and strengths in daily living skills. Items are classified under four major adaptive domains: communication, daily living skills, socialization and motor skills. The items are scored 0-2 (yes/sometimes/never). Each domain is summed, and the domain scores are converted to standardized scores. The normative score is 100, with standard deviation of 15. The standardized score is used in this study. A higher score (above 100) means better adaptive behavior. Minimum value is 0, maximum value is infinity."}], 'secondaryOutcomes': [{'measure': 'Overt Aggression Scale-Modified', 'timeFrame': 'Administered biweekly and at week 12 (termination)', 'description': 'The Modified version, Coccaro et al. is designed for outpatient use and assessment of behavior over one week. This scale was assessed biweekly. The OAS-M consists of 3 domains: Aggression, Irritability, and Suicidality (not used). Aggression Domain: 4 subscales of weighted behavior: Verbal Aggression (1), Aggression Against Objects (2), Aggression Against Others (3), and Self-Aggression (4). Within each category, severity of an event receives a scaled score (0-5) (higher score for worse behaviors) which is then multiplied by the weekly frequency of this event and weight, then totaled (for use in this study). Irritability subscale is divided into subjective/objective, 0 (low)-5 (high). The total scale has a minimum value of 0 (no display of aggressive/irritable behavior) and a maximum value of infinity (worse aggressive/irritable behavior) as reporting the number of times an aggressive/irritable behavior occurred does not have a maximum value). Higher scores mean worse outcome.'}, {'measure': 'Parental Stress Index', 'timeFrame': 'Administered during the baseline visit and on week 12 ( termination)', 'description': "This measurement assesses child and parental characteristics and parent-child relationship dimensions associated with the presence of parenting stress/ troubled relationships. It is a self-report scale completed by the parent, consisting of 101 items organized into two domains with the following subscales: (1) child characteristics domain - adaptability, demandingness, mood, distractibility/hyperactivity, acceptability of child to parent, and child's reinforcement of parent, and (2) parent characteristics domain - depression, attachment to child, social isolation, sense of competence in the parenting role, relationship with spouse/parenting partner, role restrictions, and parental health. Scores are 1-5 with 1 being strongly agree and 5 being strongly disagree. Scores are collected and standardized. The higher a score is, the more stress a parent is experiencing. Minimum value is 101 and maximum value is 505."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aggression', 'Irritability', 'Global severity'], 'conditions': ['Autism']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Amminger GP, Berger GE, Schafer MR, Klier C, Friedrich MH, Feucht M. Omega-3 Fatty Acids Supplementation in Children with Autism. Biol Psychiatry. 2006 Aug 22 Harel Z, Gascon G, Riggs S, Vaz R, Brown W, Exil G. Supplementation with omega-3 polyunsaturated fatty acids in the management of recurrent migraines in adolescents. J Adolesc Health. 2002 Aug;31(2):154-61. Itomura M, Hamazaki K, Sawazaki S, Kobayashi M, Terasawa K, Watanabe S, Hamazaki T. The effect of fish oil on physical aggression in schoolchildren. J Nutr Biochem. 2005 Mar;16(3):163-71. Mitchell EA, Aman MG, Turbott SH, Manku M. Clinical characteristics and serum essential fatty acid levels in hyperactive children. Clin Pediatr 1987; 26:406-11. Nemets H, Nemets B, Apter A, Bracha Z, Belmaker RH Omega-3 treatment of childhood depression: Am J Psychiatry. 2006 Jun;163(6):1098-100. Richardson AJ, Montgomery P. The Oxford-Durham study. Pediatrics. 2005 May;115(5):1360-6.'}], 'seeAlsoLinks': [{'url': 'http://ubhc.umdnj.edu/', 'label': 'University Behavior Health Care official website'}]}, 'descriptionModule': {'briefSummary': 'Published studies on omega 3 fatty acids in the treatment of bipolar disorder and schizophrenia have shown reductions in time to recurrence, a decrease in the positive and negative symptoms of schizophrenia, and improvements in Clinical Global Impression Scale, Young Mania Rating Scale, and HAM-D scores. The following are the hypotheses:\n\n* Omega 3 fatty acids will be superior to placebo in the acute treatment of global autism.\n* Omega 3 fatty acids will be superior to placebo in improving aggression and irritability associated with autism.\n* Omega 3 fatty acids will be superior to placebo in improving functional ability.', 'detailedDescription': "This study is an innovative treatment approach to autism. It adapts a promising adjunct therapy for bipolar disorder and schizophrenia to a new population, that of children and adolescents with autism. It will analyze the possible relationship between dosage of omega 3 fatty acids and treatment outcomes. Finally, it will attempt to identify which specific subgroups of subjects will respond to this intervention, which components and associated features are most responsive and whether this impacts subjects' quality of life. The data generated by this study is intended to support the rationale for a full scale, large multi-site clinical trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child/Teen has autism.\n* He/She is between five and seventeen years of age.\n* He/She is not in the hospital.\n* He/She has a parent or legal guardian who is willing and able to sign the informed consent.\n\nExclusion Criteria:\n\n* Child/Teen has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression).\n* He/She has caused visible harm to him/herself or is at risk for suicide.\n* He/She has an active seizure disorder or epilepsy (seizures within the past year).\n* He/She has an unstable medical illness, including heart disease.\n* He/She has experienced brain injury.\n* He/She has a history of diabetes.\n* He/She has a history of prior treatment with Omega 3 Fatty Acids.\n* He/She lives in a far away area and/or does not have regular access to transportation to the clinical facility.\n* A pregnant female or unwilling to use acceptable contraception if sexually active.'}, 'identificationModule': {'nctId': 'NCT00467818', 'briefTitle': 'Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders', 'orgStudyIdInfo': {'id': '0220060238'}, 'secondaryIdInfos': [{'id': '5R21AT002927', 'link': 'https://reporter.nih.gov/quickSearch/5R21AT002927', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omega 3 fatty Acids, drug', 'description': 'Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study.', 'interventionNames': ['Drug: Omega 3 fatty acids']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo will be dispensed to subjects in the control group', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Omega 3 fatty acids', 'type': 'DRUG', 'otherNames': ['DHA and EPA'], 'description': 'The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly.', 'armGroupLabels': ['Omega 3 fatty Acids, drug']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Same dosage as that of omega 3 fatty acids', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University Behavioral Health Care Building, UMDNJ-RWJMS', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}], 'overallOfficials': [{'name': 'Sherie L. Novotny, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Child and Adolescent Psychiatry at the University of Medicine and Dentistry of New Jersey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan at this time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Psychiatry, RWJMS', 'investigatorFullName': 'Sherie Novotny, M.D.', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}