Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-01-02 @ 12:26 AM
Study NCT ID:
NCT00078767
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2004-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacologic Treatment of PTSD in Sexually Abused Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'judith.cohen@ahn.org', 'title': 'Judith Cohen, MD', 'organization': 'Allegheny Singer Research Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '39 months', 'eventGroups': [{'id': 'EG000', 'title': 'TF-CBT + Sertraline', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day\n\nTrauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TF-CBT +Placebo', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT\n\nPlacebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TF-CBT + Sertraline', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day\n\nTrauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT'}, {'id': 'OG001', 'title': 'TF-CBT +Placebo', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT\n\nPlacebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT'}], 'classes': [{'categories': [{'title': 'PTSD diagnosis at enrollment but no PTSD at end', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'PTSD at enrollment and PTSD at end', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'No PTSD diagnosis at enrollment and no PTSD at end', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 39 months', 'description': 'Change in PTSD parameters as determined by changes in score. At enrollment, participants either did or did not have a PTSD diagnosis. The three categories displayed show participants who had the PTSD diagnosis at the time of enrollment but did have evidence of PTSD at the end of their participation, participants who had PTSD at enrollment and who continued to exhibit PTSD at the end of their participation, and those who did not have a PTSD diagnosis at the start of the trial. There are numerous criteria used to determine a PTSD diagnosis; they are not individually listed. The diagnosis was sufficient for the purposes of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TF-CBT + Sertraline', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day\n\nTrauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT'}, {'id': 'OG001', 'title': 'TF-CBT +Placebo', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT\n\nPlacebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT'}], 'classes': [{'categories': [{'title': 'Clinical symptoms CS at enrollment to no CS at end', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'No clinical symptoms at enrollment; no CS at end', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 39 months', 'description': 'Change in depressive symptoms as determined by change in score', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the "clinical symptom present at enrollment" category were tested to see if their status changed during the trial.'}, {'type': 'SECONDARY', 'title': 'Anxiety Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TF-CBT + Sertraline', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day\n\nTrauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT'}, {'id': 'OG001', 'title': 'TF-CBT +Placebo', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT\n\nPlacebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT'}], 'classes': [{'categories': [{'title': 'Cinical at start to nonclinical at end of trial', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Nonclinical at start of trial', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Clinical at start and remained clinical', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 39 months', 'description': 'Change in SCARED scores between treatment groups.There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the "clinical symptom present at enrollment" category were tested to see if their status changed during the trial.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were two categories of anxiety symptoms: participants that had clinical signs of anxiety at the time of enrollment as evidenced by their SCARED scores, and participants that did not have clinical signs of depression. Participants with clinical symptoms category were tested to see if their status changed during the trial.'}, {'type': 'SECONDARY', 'title': 'Global Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TF-CBT + Sertraline', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day\n\nTrauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT'}, {'id': 'OG001', 'title': 'TF-CBT +Placebo', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT\n\nPlacebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT'}], 'classes': [{'categories': [{'title': 'Clearly impaired to not clearly impaired', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Remained clearly impaired', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 39 months', 'description': "Change in Children's Global Assessment Scale (CGAS) between the two groups", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There were two categories of depression: participants that had clinical signs of impairment at the time of enrollment as evidenced by their CGAS scores, and participants that did not have clinical signs of depression. Participants clinical symptoms were tested to see if their status changed during the trial.'}, {'type': 'SECONDARY', 'title': 'Incidence of Suicidality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TF-CBT + Sertraline', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day\n\nTrauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT'}, {'id': 'OG001', 'title': 'TF-CBT +Placebo', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT\n\nPlacebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT'}], 'classes': [{'categories': [{'title': 'Suicigal ideation at start of trial', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Suicidal ideation at end of trial', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No suicidal ideation at start or end of trial', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 39 months', 'description': 'Change in degree of suicidal ideation during study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TF-CBT + Sertraline', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day\n\nTrauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT'}, {'id': 'FG001', 'title': 'TF-CBT +Placebo', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT\n\nPlacebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TF-CBT + Sertraline', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day\n\nTrauma-Focused Cognitive Behavioral Therapy: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT'}, {'id': 'BG001', 'title': 'TF-CBT +Placebo', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)\n\nSertraline Pill: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT\n\nPlacebo Oral Tablet: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', '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': '14', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '17'}, {'value': '14', 'groupId': 'BG001', 'lowerLimit': '10', 'upperLimit': '17'}, {'value': '14', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-03', 'studyFirstSubmitDate': '2004-03-05', 'resultsFirstSubmitDate': '2017-02-08', 'studyFirstSubmitQcDate': '2004-03-05', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-08', 'studyFirstPostDateStruct': {'date': '2004-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kiddie-Sads-Present and Lifetime (KSADS-PL) Scale for PTSD', 'timeFrame': 'Up to 39 months', 'description': 'Change in PTSD parameters as determined by changes in score. At enrollment, participants either did or did not have a PTSD diagnosis. The three categories displayed show participants who had the PTSD diagnosis at the time of enrollment but did have evidence of PTSD at the end of their participation, participants who had PTSD at enrollment and who continued to exhibit PTSD at the end of their participation, and those who did not have a PTSD diagnosis at the start of the trial. There are numerous criteria used to determine a PTSD diagnosis; they are not individually listed. The diagnosis was sufficient for the purposes of the study.'}], 'secondaryOutcomes': [{'measure': 'Mood and Feelings Questionnaire (MFQ) for Depressive Symptoms', 'timeFrame': 'Up to 39 months', 'description': 'Change in depressive symptoms as determined by change in score'}, {'measure': 'Anxiety Symptoms', 'timeFrame': 'Up to 39 months', 'description': 'Change in SCARED scores between treatment groups.There were two categories of depression: participants that had clinical signs of depression at the time of enrollment, and participants that did not have clinical signs of depression. Participants in the "clinical symptom present at enrollment" category were tested to see if their status changed during the trial.'}, {'measure': 'Global Impairment', 'timeFrame': 'Up to 39 months', 'description': "Change in Children's Global Assessment Scale (CGAS) between the two groups"}, {'measure': 'Incidence of Suicidality', 'timeFrame': 'Up to 39 months', 'description': 'Change in degree of suicidal ideation during study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PTSD', 'Depression', 'Anxiety'], 'conditions': ['Stress Disorders, Post-Traumatic']}, 'referencesModule': {'references': [{'pmid': '17581445', 'type': 'BACKGROUND', 'citation': 'Cohen JA, Mannarino AP, Perel JM, Staron V. A pilot randomized controlled trial of combined trauma-focused CBT and sertraline for childhood PTSD symptoms. J Am Acad Child Adolesc Psychiatry. 2007 Jul;46(7):811-9. doi: 10.1097/chi.0b013e3180547105.'}], 'seeAlsoLinks': [{'url': 'http://www.nctsnet.org', 'label': 'National Child Traumatic Stress Network'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD).', 'detailedDescription': 'Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in decreasing Posttraumatic Stress Disorder (PTSD) symptoms; to date the SSRIs are the only medication class with demonstrated efficacy in treating all three PTSD symptom clusters (reexperiencing, avoidance, and hyperarousal). No studies have evaluated the impact of SSRIs on PTSD symptoms in children or adolescents. Trauma-focused CBT has been shown in several studies to be efficacious in decreasing PTSD symptoms in sexually abused children and adolescents. Many children and youth with PTSD are currently prescribed SSRIs and other medications. This study will evaluate whether adding the SSRI sertraline provides additional benefits over TF-CBT treatment for sexually abused children and adolescents with PTSD. If adequate numbers of children with comorbid PTSD and depressive and/or anxiety disorders are included, it may also be possible to evaluate whether any benefit of adding sertraline is restricted to those children with comorbid disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n1. Ages 10-17 years, inclusive\n2. Confirmed sexual abuse\n3. At least 5 PTSD symptoms on KSADS-PL, with at least one symptom in each of 3 symptom clusters (reexperiencing, avoidance, arousal)\n4. Parent/primary caregiver available to participate in treatment\n5. Assent with parental consent to participate\n\nExclusion:\n\n1. Non-English speaking\n2. schizophrenia or other severe psychotic disorder\n3. MR (IQ\\<60) or PDD preventing CBT treatment\n4. taking current psychotropic medication\n5. documented substance dependence (substance abuse allowed)'}, 'identificationModule': {'nctId': 'NCT00078767', 'briefTitle': 'Pharmacologic Treatment of PTSD in Sexually Abused Children', 'organization': {'class': 'OTHER', 'fullName': 'Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)'}, 'officialTitle': 'Pharmacologic Treatment of PTSD in Sexually Abused Children', 'orgStudyIdInfo': {'id': 'K02MH001938', 'link': 'https://reporter.nih.gov/quickSearch/K02MH001938', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K02MH001938', 'link': 'https://reporter.nih.gov/quickSearch/K02MH001938', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TF-CBT + sertraline', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day', 'interventionNames': ['Behavioral: Trauma-Focused Cognitive Behavioral Therapy', 'Drug: Sertraline Pill']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TF-CBT +placebo', 'description': 'Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus placebo identical to Sertraline, provided in pill form and titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 1 to 3 pills/day (identical in appearance to 50 to 150mg/day of Sertraline)', 'interventionNames': ['Drug: Sertraline Pill', 'Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Trauma-Focused Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': '12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent', 'armGroupLabels': ['TF-CBT + sertraline']}, {'name': 'Sertraline Pill', 'type': 'DRUG', 'description': '12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT', 'armGroupLabels': ['TF-CBT + sertraline', 'TF-CBT +placebo']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': '12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT', 'armGroupLabels': ['TF-CBT +placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital Center for Traumatic Stress in Children and Adolescents', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Judith A Cohen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Judith Cohen', 'investigatorAffiliation': 'Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)'}}}}