Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-01-10 @ 5:01 PM
Study NCT ID:
NCT02296502
Status:
COMPLETED
Last Update Posted:
2019-03-11
First Post:
2014-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of DSM-IV-TR and DSM-5 for ASD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'handenbl@upmc.edu', 'phone': '412-235-5445', 'title': 'Benjamin L Handen, PhD', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'One Day', 'eventGroups': [{'id': 'EG000', 'title': 'Total SubjectsAutism Spectrum Disorder (DSM IV & 5)', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in both DSM-IV and DSM-5', 'otherNumAtRisk': 248, 'deathsNumAtRisk': 248, 'otherNumAffected': 0, 'seriousNumAtRisk': 248, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Autism Spectrum Disorder (DSM 5 Only)', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-5 but not DSM-IV', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Autism Spectrum Disorder (DSM IV Only)', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-IV but not DSM-5', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Non-Autism Spectrum Disorder', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who do not meet diagnostic criteria for ASD.', 'otherNumAtRisk': 160, 'deathsNumAtRisk': 160, 'otherNumAffected': 0, 'seriousNumAtRisk': 160, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Features of Concordant vs Discordant Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Both DSM-IV and DSM-5', 'description': 'Diagnosed with both DSM-IV and DSM-5 (concordant)'}, {'id': 'OG001', 'title': 'DSM-IV But Not DSM-5', 'description': 'Diagnosed with DSM-IV but not DSM-5 (discordant)'}], 'classes': [{'title': 'Full Scale IQ', 'categories': [{'measurements': [{'value': '76.18', 'spread': '22.52', 'groupId': 'OG000'}, {'value': '89.85', 'spread': '22.06', 'groupId': 'OG001'}]}]}, {'title': 'ABC Irritability', 'categories': [{'measurements': [{'value': '14.96', 'spread': '10.01', 'groupId': 'OG000'}, {'value': '13.94', 'spread': '10.71', 'groupId': 'OG001'}]}]}, {'title': 'ABC Social Withdrawal', 'categories': [{'measurements': [{'value': '12.83', 'spread': '8.72', 'groupId': 'OG000'}, {'value': '8.22', 'spread': '5.40', 'groupId': 'OG001'}]}]}, {'title': 'ABC Stereotypic Behavior', 'categories': [{'measurements': [{'value': '5.85', 'spread': '4.87', 'groupId': 'OG000'}, {'value': '3.85', 'spread': '3.19', 'groupId': 'OG001'}]}]}, {'title': 'ABC Hyperactivity/Noncompliance', 'categories': [{'measurements': [{'value': '19.86', 'spread': '11.86', 'groupId': 'OG000'}, {'value': '17.79', 'spread': '12.54', 'groupId': 'OG001'}]}]}, {'title': 'ABC Inappropriate Speech', 'categories': [{'measurements': [{'value': '3.64', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '2.93', 'spread': '2.70', 'groupId': 'OG001'}]}]}, {'title': 'CBCL Externalizing Problems T-Score', 'categories': [{'measurements': [{'value': '61.69', 'spread': '11.67', 'groupId': 'OG000'}, {'value': '61.57', 'spread': '12.69', 'groupId': 'OG001'}]}]}, {'title': 'CBCL Internalizing Problems T-Score', 'categories': [{'measurements': [{'value': '65.33', 'spread': '9.44', 'groupId': 'OG000'}, {'value': '62.20', 'spread': '11.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One day', 'description': 'Clinical Features of Concordant versus Discordant Groups. Full Scale IQ: Stanford-Binet IQ test.(score range 40-160; higher = greater intellectual abilties)\n\nABC = Aberrant Behavior Checklist, which includes:\n\nIrritability subscale: score range 0-45, higher = more problems. Social Withdrawal subscale: score range 0-48, higher = more problems. Stereotypic Behavior subscale: score range 0-21, higher = more problems. Hyperactivity/Noncompliance subscale: score range 0-48, higher = more problems. Inappropriate Speech subscale: score range 0-12, higher = more problems.\n\nCBCL = Child Behavior Checklist, which includes:\n\nExternalizing Problems and Internalizing problems: T scores less than 60 are considered in the normal range, 60-63 represent borderline scores, and scores greater than 63 are in the clinical range', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '278', 'groupId': 'OG003'}, {'value': '439', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PDD NOS', 'description': 'Diagnosed PDD NOS'}, {'id': 'OG001', 'title': "Asperger's", 'description': "Diagnosed Asperger's"}, {'id': 'OG002', 'title': 'Autistic Disorder', 'description': 'Diagnosed Autistic Disorder'}, {'id': 'OG003', 'title': 'ASD Total', 'description': "Diagnosed with PDD-NOS, Asperger's, or Autistic Disorder."}, {'id': 'OG004', 'title': 'Total', 'description': 'Total including not diagnosed'}], 'classes': [{'title': 'Sensitivity', 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000'}, {'value': '0.80', 'groupId': 'OG001'}, {'value': '0.97', 'groupId': 'OG002'}, {'value': '0.89', 'groupId': 'OG003'}, {'value': '0.89', 'groupId': 'OG004'}]}]}, {'title': 'Specificity', 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000'}, {'value': '0.45', 'groupId': 'OG001'}, {'value': '0.87', 'groupId': 'OG002'}, {'value': '0.99', 'groupId': 'OG003'}, {'value': '0.99', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day', 'description': 'Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV Criteria\n\nSensitivity refers to the ability of the DSM-5 to correctly identify those with ASD, whereas specificity is the ability of the DSM-5 to correctly identify those without ASD.', 'unitOfMeasure': "proportion of pts dx'd ASD w/DSM5", 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Autism Spectrum Disorder (DSM IV & 5)', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in both DSM-IV and DSM-5'}, {'id': 'FG001', 'title': 'Autism Spectrum Disorder (DSM 5 Only)', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-5 but not DSM-IV'}, {'id': 'FG002', 'title': 'Autism Spectrum Disorder (DSM IV Only)', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-IV but not DSM-5'}, {'id': 'FG003', 'title': 'Non-Autism Spectrum Disorder', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who do not meet diagnostic criteria for ASD.\n\nDSM: Comparing use of DSM-IV versus DSM-5 criteria for autism spectrum disorder'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '160'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '160'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}, {'value': '439', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Autism Spectrum Disorder (DSM IV & 5)', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in both DSM-IV and DSM-5'}, {'id': 'BG001', 'title': 'Autism Spectrum Disorder (DSM 5 Only)', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-5 but not DSM-IV'}, {'id': 'BG002', 'title': 'Autism Spectrum Disorder (DSM IV Only)', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-IV but not DSM-5'}, {'id': 'BG003', 'title': 'Non-Autism Spectrum Disorder', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who do not meet diagnostic criteria for ASD.\n\nDSM: Comparing use of DSM-IV versus DSM-5 criteria for autism spectrum disorder'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.43', 'spread': '4.00', 'groupId': 'BG000'}, {'value': '12.66', 'spread': '0', 'groupId': 'BG001'}, {'value': '8.85', 'spread': '3.89', 'groupId': 'BG002'}, {'value': '7.75', 'spread': '4.28', 'groupId': 'BG003'}, {'value': '7.1', 'spread': '4.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}, {'value': '348', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}, {'value': '374', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'Caucasian/White', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}, {'value': '341', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}, {'title': 'Unknown/Unable to collect', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parental Education', 'classes': [{'categories': [{'title': '< High school', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'High school', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '106', 'groupId': 'BG004'}]}, {'title': 'Some College', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '139', 'groupId': 'BG004'}]}, {'title': "Bachelor's Degree", 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': 'Postgraduate', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}]}, {'title': 'Unable to collect', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Household Income', 'classes': [{'categories': [{'title': '≤ $24,999', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}, {'title': '$25,000 - 49,999', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}, {'title': '$50,000 - 74,999', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}]}, {'title': '$75,000 - 99,999', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': '≥ $100,000', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}, {'title': 'Unable to collect', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-21', 'studyFirstSubmitDate': '2014-11-18', 'resultsFirstSubmitDate': '2017-07-07', 'studyFirstSubmitQcDate': '2014-11-18', 'lastUpdatePostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-21', 'studyFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Features of Concordant vs Discordant Groups', 'timeFrame': 'One day', 'description': 'Clinical Features of Concordant versus Discordant Groups. Full Scale IQ: Stanford-Binet IQ test.(score range 40-160; higher = greater intellectual abilties)\n\nABC = Aberrant Behavior Checklist, which includes:\n\nIrritability subscale: score range 0-45, higher = more problems. Social Withdrawal subscale: score range 0-48, higher = more problems. Stereotypic Behavior subscale: score range 0-21, higher = more problems. Hyperactivity/Noncompliance subscale: score range 0-48, higher = more problems. Inappropriate Speech subscale: score range 0-12, higher = more problems.\n\nCBCL = Child Behavior Checklist, which includes:\n\nExternalizing Problems and Internalizing problems: T scores less than 60 are considered in the normal range, 60-63 represent borderline scores, and scores greater than 63 are in the clinical range'}, {'measure': 'Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV Criteria', 'timeFrame': 'day', 'description': 'Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV Criteria\n\nSensitivity refers to the ability of the DSM-5 to correctly identify those with ASD, whereas specificity is the ability of the DSM-5 to correctly identify those without ASD.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DSM Diagnosis'], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'The study aim is to prospectively compare DSM-IV-TR and DSM-5 criteria for Autism Spectrum Disorder (ASD) in a sample of 250 children and adolescents who meet DSM-IV-TR criteria for ASD and 150 children and adolescents referred for diagnosis who do not meet DSM-IV-TR criteria.Families and children will be recruited from eight sites affiliated with the Autism Treatment Network (ATN). Participants must be between the ages of 2.0 and 17.11 years who undergo an ATN assessment at one of the eight sites. Both subjects who are found to meet criteria of ASD/PDD and those who do not meet criteria (after completing the ATN assessment) will be enrolled. After completing the standard ATN assessment, clinicians will complete a DSM-IV and DSM-5 checklist for ASD/PDD.', 'detailedDescription': 'The study will involve the following aims and hypotheses:\n\nAim 1: To prospectively compare DSM-IV-TR and DSM-5 criteria for Autism Spectrum Disorder in a sample of 250 children and adolescents who meet DSM-IV-TR criteria for ASD.\n\nAim 2: To examine the impact of IQ, comorbid behavior problems, age and ASD symptom severity on the specificity and sensitivity of DSM-5 diagnostic criteria.\n\nHypothesis 1: DSM-5 diagnostic criteria will have good specificity but poor sensitivity when comparing results with DSM-IV-TR ASD diagnostic criteria.\n\nHypothesis 2: Lower IQ will be associated with higher DSM-IV/DSM-5 concordance.\n\nMETHODS\n\nFamilies and children will be recruited from seven sites affiliated with the Autism Treatment Network. An IRB submission and consent form will be developed for each of the participating programs. Parents (along with child assent and/or consent, depending upon the study site) will sign informed consent to participate in the study. Participants must be between the ages of 2.0 and 17.11 years who undergo an ATN assessment at one of the seven sites. Both subjects who are found to meet criteria of ASD/PDD and those who do not meet criteria (after completing the ATN assessment) will be enrolled. Therefore, the only inclusion criteria will be that the child be between 2.0 and 17.11 years of age and be referred for an ATN diagnostic evaluation. The only exclusion criteria will be when the ADOS is determined by the clinician to be "invalid." Examples may include a child who is extremely non-compliant, severely depressed, or unresponsive. The following measures will be obtained:\n\nADOS:\n\nAll participants will be administered the Autism Diagnostic Observation Schedule 2 (Lord et al., 2012). The ADOS2 is a standardized, interactive protocol for direct observation (45 minutes) of social and communicative behavior associated with ASD, and consists of structured and semi-structured methods for interaction. This assessment tool is designed to assess a wide range of children and adolescents, from nonverbal/barely verbal children to adolescents and adults with fluent speech.\n\nAssessment of IQ:\n\nAll participants will have an updated assessment of full IQ using any one of the following tools: the Stanford-Binet V (Roid, 2003), Wechsler Intelligence Scales for Children IV (Wechsler, 2003), the Wechsler Preschool and Primary Scale of Intelligence - Third Edition (Wechsler, 2002), Differential Ability Scales, 2nd Edition, (Elliot, 2007), Wechsler Abbreviated Scale of Intelligence 2 (Wechsler, 2011) or Mullen Scales of Early Learning AGS Edition (Mullen, 1989). If a child has had a full-scale IQ assessment conducted within one year, this will be accepted in place of an updated evaluation.\n\nAssessment of Behavior:\n\nChild Behavior Checklist (CBCL): The CBCL (Achenbach 2001; Achenbach \\& Rescorla, 2000) is a parent completed questionnaire comprising of 100 items (scored on a 3-point likert scale from "not true" to "very true or often true"). There is a preschool version (1.5-5 years) and a school version (6-18 years). A range of subscales are derived, including externalizing and internalizing disorders as well as more specific co-morbidities such as anxiety, ADHD and PDD.\n\nAberrant Behavior Checklist (ABC). The ABC (Aman \\& Singh, 1986) is a standardized scale comprising 58 items, for assessing problem behavior in subjects with developmental disabilities. The ABC was empirically derived from ratings on approximately 1,000 subjects, and the items resolve onto five subscales: (I). Irritability (15 items), (II) Lethargy/Social Withdrawal (16 items), (III) Stereotypic Behavior (7 items), (IV) Hyperactivity (16 items), and (V) Inappropriate Speech (4 items). The primary caregiver will serve as the rater.\n\nAdditional Information:\n\nDemographic Questionnaire: Parent will complete the ATN demographic questionnaire, which inquires about family make-up and education, medical history, etc.\n\nSupplemental Information: At all sites, clinicians will conduct clinical interviews and informal observations sufficient to gather enough information to inform DSM-IV and DSM-5 criteria determination. Sites may also use supplemental information that is available to them. For example, prior evaluations may have been conducted. In addition, sites also may use a variety of additional questionnaires, such as the Social Communication Questionnaire (ref) or the Social Responsiveness Scale (SRS). Questionnaires or reports from a child\'s school are also frequently obtained as part of the assessment process. Such information can be used by the evaluation team to determine the final diagnosis.\n\nDiagnostic Determination:\n\nAt the conclusion of the evaluation, the assessor (along with any other team members) will use the information obtained from the above sources to complete the DSM-IV checklist. If more than one clinician was involved in the assessment, a consensus will be obtained. After the DSM-IV checklist has been completed, the DSM-5 checklist will be completed using the same information (including the consensus scores on the DSM-IV checklist).\n\nDSM-IV Checklist: The DSM-IV checklist (APA, 2002) is a clinician-completed questionnaire that lists the X symptoms for autistic disorder. Each is scored as being "present/absent." Finally, the clinician notes which, if any, PDD diagnosis was made (based upon the results of the DSM-IV checklist).\n\nDSM-5 Checklist: The DSM-5 checklist is a clinician-completed questionnaire that lists the seven symptoms for autism spectrum disorder from DSM5 (APA 2013). Each is scored as being "present/absent." In addition, there is a column for noting if the symptom is currently present or was only reported in the past ("present by history"). Finally, the clinician notes if an ASD diagnosis was made (based upon the results of the DSM-5 checklist).\n\nFinal Diagnosis:\n\nThe following information regarding each subject\'s final diagnosis will be entered onto the Diagnostic Form:\n\nADOS Results: Autism, Autism Spectrum, Nonspectrum\n\nDSM-IV Diagnosis: Autism, PDD NOS, Asperger\'s Disorder, Nonspectrum\n\nDSM-5 Diagnosis: ASD, Social Communication Disorder, Nonspectrum\n\nConsensus Diagnosis Old: Autism, PDD NOS, Asperger\'s, Nonspectrum\n\nConsensus Diagnosis New: Autism Spectrum Disorder (Level 1, 2 or 3); Nonspectrum\n\nItem-level and algorithim scores: Should be included in the database for the ADOS-2 and both DSM-IV and DSM-5 checklists.\n\nAdditional Variables:\n\nThe following information will also be noted:\n\n* List of additional measures used to make the diagnostic decision (e.g., SRS School, SRS Home, SCQ, Vineland)\n* If child is Nonspectrum, indicate other primary diagnoses (e.g., OCD, Anxiety Disorder, ADHD, RAD)\n\nStatistical Analysis\n\nHypothesis 1: DSM-5 diagnostic criteria will have good specificity but poor sensitivity when comparing results with DSM-IV-TR ASD diagnostic criteria. A Chi-Square test will be used to compare the rate of ASD diagnosis (autistic disorder, PDD-NOS, Asperger\'s disorder) using DSM-IV-TR versus DSM-5 criteria. Based upon the DSM-IV-TR diagnosis (which will serve as the gold standard), both specificity and sensitivity for DSM-5 will be calculated. Sensitivity will be calculated as the proportion of individuals who meet DSM-IV-TR criteria for an ASD (including autistic disorder, PDD-NOS, and Asperger\'s disorder) who also meet DSM-IV criteria for an ASD (i.e., true positives). Specificity will be calculated as the proportion of individuals who do not meet DSM-IV-TR criteria who also do not meet DSM-5 criteria (i.e., true negatives). Sensitivity and specificity will also be calculated for each of the three DSM-IV subtypes (autistic disorder, PDD NOS, and Asperger\'s disorder).\n\nHypothesis 2: Lower IQ will be associated with greater DSM-IV/DSM-5 concordance. Concordance will be defined as agreement between DSM-IV and DSM-5 regarding the presence or absence of an ASD diagnosis; discordance will be defined as disagreement (either DSM-IV positive and DSM-5 negative, or DSM-IV negative and DSM-5 positive). Logistic regression will be used to determine whether Full Scale IQ score predicts concordance (versus discordance).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All children ages 2-17 who are being evaluated for a possible diagnosis of autism spectrum disorder', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 2-17\n* question of possible autism spectrum disorder\n\nExclusion Criteria:\n\n* \\<2 years old \\>17 years old'}, 'identificationModule': {'nctId': 'NCT02296502', 'briefTitle': 'Comparison of DSM-IV-TR and DSM-5 for ASD', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Comparison of DSM-IV-TR and DSM-5 Diagnostic Criteria for Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': 'DSM5 and ASD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Autism Spectrum Disorder (DSM IV & 5)', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in both DSM-IV and DSM-5', 'interventionNames': ['Other: DSM']}, {'label': 'Autism Spectrum Disorder (DSM 5 only)', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-5 but not DSM-IV', 'interventionNames': ['Other: DSM']}, {'label': 'Autism Spectrum Disorder (DSM IV only)', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-IV but not DSM-5', 'interventionNames': ['Other: DSM']}, {'label': 'Non-Autism Spectrum Disorder', 'description': 'All children and adolescents seen for autism diagnostic evaluations at the study sites who do not meet diagnostic criteria for ASD.', 'interventionNames': ['Other: DSM']}], 'interventions': [{'name': 'DSM', 'type': 'OTHER', 'description': 'Comparing use of DSM-IV versus DSM-5 criteria for autism spectrum disorder', 'armGroupLabels': ['Autism Spectrum Disorder (DSM 5 only)', 'Autism Spectrum Disorder (DSM IV & 5)', 'Autism Spectrum Disorder (DSM IV only)', 'Non-Autism Spectrum Disorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Hospital of Cincinnati", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43081', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37240', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Benjamin Handen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, {'name': 'Vanderbilt University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professof of Psychiatry', 'investigatorFullName': 'Benjamin L Handen, PhD, BCBA-D', 'investigatorAffiliation': 'University of Pittsburgh'}}}}