Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT00227903
Status:
COMPLETED
Last Update Posted:
2020-04-15
First Post:
2005-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Therapeutic Substance Abuse Treatment in Pregnancy - 1
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D019970', 'term': 'Cocaine-Related Disorders'}, {'id': 'D002189', 'term': 'Marijuana Abuse'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003419', 'term': 'Crisis Intervention'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kimberly.Yonkers@yale.edu', 'phone': '1-203-764-6621', 'title': 'Dr. Kimberly Yonkers', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Did not acheive desired sample size; results were averaged across substances; women were not seeking substance abuse treatment (i.e. they were attending for prenatal care); treatment was brief'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Brief Advice', 'description': 'Advice and education', 'otherNumAtRisk': 86, 'otherNumAffected': 0, 'seriousNumAtRisk': 86, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling', 'otherNumAtRisk': 82, 'otherNumAffected': 0, 'seriousNumAtRisk': 82, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Days Used Drugs or Alcohol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Intake', 'categories': [{'measurements': [{'value': '18', 'spread': '27', 'groupId': 'OG000'}, {'value': '21', 'spread': '34', 'groupId': 'OG001'}]}]}, {'title': 'Delivery', 'categories': [{'measurements': [{'value': '6', 'spread': '17', 'groupId': 'OG000'}, {'value': '7', 'spread': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Not corrected for multiple comparison', 'groupDescription': 'We estimated that 110 people with 10% attrition would provide 80% power', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': '2 degrees of freedom'}], 'paramType': 'MEAN', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized participants'}, {'type': 'SECONDARY', 'title': 'Incidence of Preterm Births', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'At delivery', 'unitOfMeasure': 'preterm births', 'reportingStatus': 'POSTED', 'populationDescription': 'A singleton live birth occurred in 163 subjects, and 5 had twins. Data was collected from the 84 women of the Brief Advice category and the 79 women of the MI-CBT category who had singleton live births.'}, {'type': 'PRIMARY', 'title': 'Percentage of Days Used Drugs or Alcohol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Delivery', 'categories': [{'measurements': [{'value': '6', 'spread': '17', 'groupId': 'OG000'}, {'value': '7', 'spread': '22', 'groupId': 'OG001'}]}]}, {'title': '3 months post-delivery', 'categories': [{'measurements': [{'value': '14', 'spread': '25', 'groupId': 'OG000'}, {'value': '13', 'spread': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Not corrected for multiple comparison.', 'groupDescription': 'We estimated that 110 people with 10% attrition would provide 80% power.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': '2 degrees of freedom'}], 'paramType': 'MEAN', 'timeFrame': 'delivery to 3 months post-delivery', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized participants with data from delivery and 3 months post-delivery'}, {'type': 'SECONDARY', 'title': 'Incidence of Low Birth Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'At delivery', 'unitOfMeasure': 'low weight births', 'reportingStatus': 'POSTED', 'populationDescription': 'Only singleton live births, which occurred in 163 subjects, were analyzed. Three of the women in the MI-CBT group had an infant of unknown birth weight, and were not included in analysis.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Intake', 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000'}, {'value': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000'}, {'value': '0.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.77', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.67', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000'}, {'value': '0.76', 'groupId': 'OG001'}]}]}, {'title': '3 months post-delivery', 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000'}, {'value': '0.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.42', 'ciUpperLimit': '2.62', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery to 3 months post-delivery', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with data available from the time frame.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Intake', 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000'}, {'value': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000'}, {'value': '0.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.34', 'ciUpperLimit': '2.72', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants for whom urine test data was available.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Abstinent From Drugs According to Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000'}, {'value': '0.84', 'groupId': 'OG001'}]}]}, {'title': '3 months post-delivery', 'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000'}, {'value': '0.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.88', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.57', 'ciUpperLimit': '2.57', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery to 3 months post-delivery', 'description': 'Based on urine tests for marijuana, cocaine, or opioids', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants for whom urine data was available during the time frame.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Intake', 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000'}, {'value': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000'}, {'value': '0.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.32', 'ciUpperLimit': '1.84', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'description': 'Based on urine tests for marijuana, cocaine or opioids.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with both self-report and urine data available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Intake', 'categories': [{'measurements': [{'value': '14', 'spread': '25', 'groupId': 'OG000'}, {'value': '15', 'spread': '27', 'groupId': 'OG001'}]}]}, {'title': 'Delivery', 'categories': [{'measurements': [{'value': '4', 'spread': '11', 'groupId': 'OG000'}, {'value': '6', 'spread': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without a baseline diagnosis of drug use or dependence.'}, {'type': 'PRIMARY', 'title': 'Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Delivery', 'categories': [{'measurements': [{'value': '4', 'spread': '11', 'groupId': 'OG000'}, {'value': '6', 'spread': '20', 'groupId': 'OG001'}]}]}, {'title': '3 months post-delivery', 'categories': [{'measurements': [{'value': '11', 'spread': '20', 'groupId': 'OG000'}, {'value': '14', 'spread': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Delivery to 3 months post-delivery', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without a baseline diagnosis for drug abuse or dependence with data available for time frame.'}, {'type': 'PRIMARY', 'title': 'Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Intake', 'categories': [{'measurements': [{'value': '27', 'spread': '29', 'groupId': 'OG000'}, {'value': '40', 'spread': '45', 'groupId': 'OG001'}]}]}, {'title': 'Delivery', 'categories': [{'measurements': [{'value': '10', 'spread': '25', 'groupId': 'OG000'}, {'value': '13', 'spread': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline diagnosis for drug abuse or dependence.'}, {'type': 'PRIMARY', 'title': 'Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Delivery', 'categories': [{'measurements': [{'value': '10', 'spread': '25', 'groupId': 'OG000'}, {'value': '13', 'spread': '28', 'groupId': 'OG001'}]}]}, {'title': '3 months post-delivery', 'categories': [{'measurements': [{'value': '18', 'spread': '32', 'groupId': 'OG000'}, {'value': '8', 'spread': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Delivery to 3 months post-delivery', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000'}, {'value': '0.75', 'groupId': 'OG001'}]}]}, {'title': '3 months post-delivery', 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000'}, {'value': '0.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.27', 'ciUpperLimit': '2.11', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery to 3 months post-delivery', 'description': 'Based on urine tests for marijuana, cocaine, or opioids.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with both self-report and urine data available during the time frame.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Intake', 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000'}, {'value': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000'}, {'value': '0.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.44', 'ciUpperLimit': '3.14', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without a baseline diagnosis of drug abuse or dependence.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000'}, {'value': '0.81', 'groupId': 'OG001'}]}]}, {'title': '3 months post-delivery', 'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000'}, {'value': '0.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.46', 'ciLowerLimit': '0.47', 'ciUpperLimit': '4.52', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery to 3 months post-delivery', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without a baseline diagnosis of drug abuse or dependence with data available for the time frame.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Intake', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000'}, {'value': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.71', 'groupId': 'OG000'}, {'value': '0.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.08', 'ciUpperLimit': '1.02', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline diagnosis of drug abuse or dependence.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.71', 'groupId': 'OG000'}, {'value': '0.61', 'groupId': 'OG001'}]}]}, {'title': '3 months post-delivery', 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000'}, {'value': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.10', 'ciUpperLimit': '3.90', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery to 3 months post-delivery', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Intake', 'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000'}, {'value': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000'}, {'value': '0.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.32', 'ciUpperLimit': '4.20', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'description': 'Based on urine tests for marijuana, cocaine or opioids.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without a baseline diagnosis for drug abuse or dependence and with urine data.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000'}, {'value': '0.85', 'groupId': 'OG001'}]}]}, {'title': '3 months post-delivery', 'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG000'}, {'value': '0.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.35', 'ciUpperLimit': '5.07', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery to 3 months post-delivery', 'description': 'Based on urine tests for marijuana, cocaine or opioids.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without a baseline diagnosis of drug abuse or dependence and urine data during the time frame.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Intake', 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000'}, {'value': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000'}, {'value': '0.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.14', 'ciUpperLimit': '5.23', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'description': 'Based on urine tests for marijuana, cocaine or opioids.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000'}, {'value': '0.78', 'groupId': 'OG001'}]}]}, {'title': '3 months post-delivery', 'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000'}, {'value': '0.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.21', 'ciUpperLimit': '7.12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery to 3 months post-delivery', 'description': 'Based on urine tests for marijuana, cocaine or opioids.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Intake', 'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000'}, {'value': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000'}, {'value': '0.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '0.46', 'ciUpperLimit': '3.55', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'description': 'Based on urine tests for marijuana, cocaine or opioids.', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.76', 'groupId': 'OG000'}, {'value': '0.76', 'groupId': 'OG001'}]}]}, {'title': '3 months post-delivery', 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000'}, {'value': '0.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.35', 'ciUpperLimit': '4.17', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery to 3 months post-delivery', 'description': 'Based on urine tests for marijuana, cocaine or opioids', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Intake', 'categories': [{'measurements': [{'value': '0.14', 'groupId': 'OG000'}, {'value': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000'}, {'value': '0.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.04', 'ciUpperLimit': '1.63', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'description': 'Based on urine tests for marijuana, cocaine or opioids', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline diagnosis for drug abuse or dependence, and with both self-report and urine data.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Delivery', 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000'}, {'value': '0.67', 'groupId': 'OG001'}]}]}, {'title': '3 months post-delivery', 'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000'}, {'value': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '0.04', 'ciUpperLimit': '3.74', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery to 3 months post-delivery', 'description': 'Based on urine tests for marijuana, cocaine or opioids', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adequacy of Received Services', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Inadequate (0-49% attendance)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Intermediate (50%-79% attendance)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Adequate (80%-109% attendance)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Adequate plus (110+%)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'After prenatal care initiation', 'description': 'Based on prenatal care attendance: the percent of visits attended after prenatal care initiation, accounting for time of delivery. Attendance was rated according to the Kotelchuck Adequacy of Prenatal Care Index. Only the normally scheduled prenatal car visits were included.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants, 6 women had unkown attendance.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Attendance of Treatment Outside the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'OG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'classes': [{'title': 'Participants who attended prior to delivery', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Participants who attended prior to 3 months post', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '30 days prior to assessment', 'description': 'The number of patients who attended outside treatment in the 30 days prior to each assessment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all randomized participants with data availabe at time frames'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'FG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'Received ≥ 1 Follow-up Assessment', 'achievements': [{'comment': '1 participant did not receive any treatment sessions.', 'groupId': 'FG000', 'numSubjects': '86'}, {'comment': '4 participants did not receive any treatment sessions.', 'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants with at least 1 follow-up assessment were analyzed', 'groupId': 'FG000', 'numSubjects': '86'}, {'comment': 'Participants with at least 1 follow-up assessment were analyzed', 'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Subject moved out of area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Miscarriage', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment occurred between June 2006 and September 2009, with follow-up concluding in July 2010. Women were screened and recruited while attending obstetrical appointments in two hospital-based reproductive health clinics in New Haven and Bridgeport, CT.', 'preAssignmentDetails': '13 women who were consented to the trial and provisionally were found to be eligible either declined or failed to complete intake, 1 had an incomplete intake and 1 was found to be ineligible at intake'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Brief Advice', 'description': 'Advice and education'}, {'id': 'BG001', 'title': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<20 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': '20-34 years', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}, {'title': '>35 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '168', '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': [{'title': 'White', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants could indicate more than one race/ethnicity category. All results were counted and categorized, leading to a total count greater than the number baseline participants.', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education (years)', 'classes': [{'title': '<12', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': '12', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': '13-15', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': '16+', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Parity', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': '2+', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Parity defined as number of previous births', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational age at intake', 'classes': [{'title': 'Weeks 1-8', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Weeks 9-16', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Weeks 17-24', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Weeks 25 or later', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prenatal care initiation', 'classes': [{'title': 'Weeks 1-8', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Weeks 9-16', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}, {'title': 'Weeks 17-24', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Week 25 or later', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Site', 'classes': [{'title': 'Bridgeport Hospital', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Yale New Haven Hospital', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'MINI drug or alcohol abuse or dependence', 'classes': [{'title': 'Participants diagnosed with abuse or dependence', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Participants without such a diagnosis', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Past-month use', 'classes': [{'title': 'Alcohol (any)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Alcohol (intoxication)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Heroin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Methadone', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Opiates (excluding methadone)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Barbiturates', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Sedatives', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Cocaine', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Amphetamines', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Marijuana', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': 'Hallucinogens', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Inhalants', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants could indicate use of more than one substance in the past month. All results were counted and categorized, leading to a total count greater than the number of baseline participants.', 'unitOfMeasure': 'participants'}, {'title': 'Primary Drug', 'classes': [{'title': 'Alcohol', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Cocaine', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Marijuana', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Primary drug was determined by combining a) self-reported recent use of substances and b) preferred substance according to the subject. If the participant used only one substance in the past 28 days, it was designated as primary. If the woman used more than one or did not endorse use of a substance in the prior 28 days, we used patient-identified primary drug. Subjects who reported more than one drug as primary were classified as "other" regardless of substances endorsed.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Analysis excluded women with no follow-up assessments.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-01', 'studyFirstSubmitDate': '2005-09-27', 'resultsFirstSubmitDate': '2013-06-14', 'studyFirstSubmitQcDate': '2005-09-27', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-06-14', 'studyFirstPostDateStruct': {'date': '2005-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adequacy of Received Services', 'timeFrame': 'After prenatal care initiation', 'description': 'Based on prenatal care attendance: the percent of visits attended after prenatal care initiation, accounting for time of delivery. Attendance was rated according to the Kotelchuck Adequacy of Prenatal Care Index. Only the normally scheduled prenatal car visits were included.'}, {'measure': 'Attendance of Treatment Outside the Study', 'timeFrame': '30 days prior to assessment', 'description': 'The number of patients who attended outside treatment in the 30 days prior to each assessment.'}], 'primaryOutcomes': [{'measure': 'Percentage of Days Used Drugs or Alcohol', 'timeFrame': 'intake to delivery, an average of 21 weeks'}, {'measure': 'Percentage of Days Used Drugs or Alcohol', 'timeFrame': 'delivery to 3 months post-delivery'}, {'measure': 'Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol', 'timeFrame': 'intake to delivery, an average of 21 weeks'}, {'measure': 'Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol', 'timeFrame': 'Delivery to 3 months post-delivery'}, {'measure': 'Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol', 'timeFrame': 'intake to delivery, an average of 21 weeks'}, {'measure': 'Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol', 'timeFrame': 'Delivery to 3 months post-delivery'}], 'secondaryOutcomes': [{'measure': 'Incidence of Preterm Births', 'timeFrame': 'At delivery'}, {'measure': 'Incidence of Low Birth Weight', 'timeFrame': 'At delivery'}, {'measure': 'Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report', 'timeFrame': 'intake to delivery, an average of 21 weeks'}, {'measure': 'Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report', 'timeFrame': 'Delivery to 3 months post-delivery'}, {'measure': 'Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine', 'timeFrame': 'intake to delivery, an average of 21 weeks'}, {'measure': 'Proportion of Participants Abstinent From Drugs According to Urine', 'timeFrame': 'Delivery to 3 months post-delivery', 'description': 'Based on urine tests for marijuana, cocaine, or opioids'}, {'measure': 'Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'description': 'Based on urine tests for marijuana, cocaine or opioids.'}, {'measure': 'Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine', 'timeFrame': 'Delivery to 3 months post-delivery', 'description': 'Based on urine tests for marijuana, cocaine, or opioids.'}, {'measure': 'Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report', 'timeFrame': 'intake to delivery, an average of 21 weeks'}, {'measure': 'Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report', 'timeFrame': 'Delivery to 3 months post-delivery'}, {'measure': 'Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report', 'timeFrame': 'intake to delivery, an average of 21 weeks'}, {'measure': 'Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report', 'timeFrame': 'Delivery to 3 months post-delivery'}, {'measure': 'Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'description': 'Based on urine tests for marijuana, cocaine or opioids.'}, {'measure': 'Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine', 'timeFrame': 'Delivery to 3 months post-delivery', 'description': 'Based on urine tests for marijuana, cocaine or opioids.'}, {'measure': 'Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'description': 'Based on urine tests for marijuana, cocaine or opioids.'}, {'measure': 'Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine', 'timeFrame': 'Delivery to 3 months post-delivery', 'description': 'Based on urine tests for marijuana, cocaine or opioids.'}, {'measure': 'Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'description': 'Based on urine tests for marijuana, cocaine or opioids.'}, {'measure': 'Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine', 'timeFrame': 'Delivery to 3 months post-delivery', 'description': 'Based on urine tests for marijuana, cocaine or opioids'}, {'measure': 'Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine', 'timeFrame': 'intake to delivery, an average of 21 weeks', 'description': 'Based on urine tests for marijuana, cocaine or opioids'}, {'measure': 'Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine', 'timeFrame': 'Delivery to 3 months post-delivery', 'description': 'Based on urine tests for marijuana, cocaine or opioids'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Alcohol Abuse', 'Cocaine Abuse', 'Marijuana Abuse']}, 'referencesModule': {'references': [{'pmid': '19350369', 'type': 'BACKGROUND', 'citation': 'Yonkers KA, Howell HB, Allen AE, Ball SA, Pantalon MV, Rounsaville BJ. A treatment for substance abusing pregnant women. Arch Womens Ment Health. 2009 Aug;12(4):221-7. doi: 10.1007/s00737-009-0069-2. Epub 2009 Apr 7.'}, {'pmid': '18956504', 'type': 'BACKGROUND', 'citation': 'Hine CE, Howell HB, Yonkers KA. Integration of medical and psychological treatment within the primary health care setting. Soc Work Health Care. 2008;47(2):122-34. doi: 10.1080/00981380801970244.'}, {'pmid': '20859145', 'type': 'BACKGROUND', 'citation': 'Yonkers KA, Gotman N, Kershaw T, Forray A, Howell HB, Rounsaville BJ. Screening for prenatal substance use: development of the Substance Use Risk Profile-Pregnancy scale. Obstet Gynecol. 2010 Oct;116(4):827-833. doi: 10.1097/AOG.0b013e3181ed8290.'}, {'pmid': '22489543', 'type': 'BACKGROUND', 'citation': 'Quesada O, Gotman N, Howell HB, Funai EF, Rounsaville BJ, Yonkers KA. Prenatal hazardous substance use and adverse birth outcomes. J Matern Fetal Neonatal Med. 2012 Aug;25(8):1222-7. doi: 10.3109/14767058.2011.602143. Epub 2012 May 11.'}, {'pmid': '22795046', 'type': 'RESULT', 'citation': 'Yonkers KA, Forray A, Howell HB, Gotman N, Kershaw T, Rounsaville BJ, Carroll KM. Motivational enhancement therapy coupled with cognitive behavioral therapy versus brief advice: a randomized trial for treatment of hazardous substance use in pregnancy and after delivery. Gen Hosp Psychiatry. 2012 Sep-Oct;34(5):439-49. doi: 10.1016/j.genhosppsych.2012.06.002. Epub 2012 Jul 12.'}, {'pmid': '28270105', 'type': 'DERIVED', 'citation': 'Xu X, Yonkers KA, Ruger JP. Economic evaluation of a behavioral intervention versus brief advice for substance use treatment in pregnant women: results from a randomized controlled trial. BMC Pregnancy Childbirth. 2017 Mar 7;17(1):83. doi: 10.1186/s12884-017-1260-5.'}, {'pmid': '24447885', 'type': 'DERIVED', 'citation': 'Forray A, Gotman N, Kershaw T, Yonkers KA. Perinatal smoking and depression in women with concurrent substance use. Addict Behav. 2014 Apr;39(4):749-56. doi: 10.1016/j.addbeh.2013.12.008. Epub 2013 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is... To assess whether a behavioral treatment that combines motivational enhancement and cognitive skills training therapy (MET-CBT) is more effective than brief advice in: 1) decreasing use of a full range of psychoactive substances (e.g. marijuana, cocaine, methamphetamines, alcohol, nicotine, opioids) in pregnant substance using and dependent women; 2) decreasing HIV risk behavior; 3) improving birth outcomes (longer gestations and greater birth weight).', 'detailedDescription': 'We propose an integrated system of counseling services onsite in primary care obstetrical clinics, comparing a manualized brief advice (closely approximating "treatment as usual") to manualized motivationally enhanced cognitive behavioral therapy. Treatment providers are obstetrical nurses. Therapy patients are taught skill sets designed to enhance motivation to abstain from drugs of abuse, as well as designed to prevent relapse during the perinatal period. It is our hypothesis that therapy patients will be more successful at achieving stated study aims than those receiving brief advice.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPregnant women, age 16 or older, alcohol or illicit drug use in the past 30 days -\n\nExclusion Criteria:\n\nNonfluent in English or Spanish, pending incarceration, psychotic, cognitively unable to give informed consent, actively suicidal or homicidal, already engaged in addictions treatment, primarily addicted to nicotine or heroin.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00227903', 'acronym': 'PRIDE-P', 'briefTitle': 'Therapeutic Substance Abuse Treatment in Pregnancy - 1', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)', 'orgStudyIdInfo': {'id': '0402026466'}, 'secondaryIdInfos': [{'id': 'R01DA019135', 'link': 'https://reporter.nih.gov/quickSearch/R01DA019135', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MI-CBT', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling', 'interventionNames': ['Behavioral: MI-CBT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brief Advice', 'description': 'Advice and education', 'interventionNames': ['Behavioral: Brief Advice']}], 'interventions': [{'name': 'MI-CBT', 'type': 'BEHAVIORAL', 'description': 'Motivationally-enhanced cognitive behavioral skills counseling', 'armGroupLabels': ['MI-CBT']}, {'name': 'Brief Advice', 'type': 'BEHAVIORAL', 'description': 'Advice and education', 'armGroupLabels': ['Brief Advice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bridgeport Hospital', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale-New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Kimberly A Yonkers, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'only aggregate de-identified data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}