Ignite Creation Date:
2025-12-24 @ 11:54 AM
Ignite Modification Date:
2025-12-25 @ 11:54 AM
Study NCT ID:
NCT02337361
Status:
COMPLETED
Last Update Posted:
2019-01-25
First Post:
2014-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Computerized Tool for Preventing Prenatal Drinking
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mnayak@arg.org', 'phone': '510-898-5849', 'title': 'Madhabika B. Nayak', 'organization': 'Public Health Institute/Alcohol Research Group'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Participants in the e-SBI group were re-administered the brief intervention at 3-month follow-up if they reported any alcohol use at that follow-up.'}}, 'adverseEventsModule': {'timeFrame': '18 months, 6 months per participation, overall time frame includes screening for eligibility until the completion of the last (6-month follow-up) for the participants enrolled into the study last', 'description': 'The trial did not involve drugs or biologics, devices, or invasive procedures and involved a behavioral intervention with no known risks to participants.\n\nDrinking and mental health behaviors included in outcomes were assessed at each follow up. But no adverse events were observed any time in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'e-SBI', 'description': "Single session, Electronic SBI for risky alcohol use\n\nElectronic SBI: Bilingual (English and Spanish) e-SBI with four key components:\n\n1\\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.", 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Treatment as usual with only assessment', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 0, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting Risky Alcohol Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'e-SBI', 'description': "Single session, Electronic SBI for risky alcohol use\n\nElectronic SBI: Bilingual (English and Spanish) e-SBI with four key components:\n\n1\\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."}, {'id': 'OG001', 'title': 'Control', 'description': 'Treatment as usual with only assessment'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': '3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Generalized estimating equations (GEE)(Diggle et al. 2002) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.'}, {'groupIds': ['OG001'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Generalized estimating equations tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'Risky alcohol use is defined as drinking 8 or more drinks in a week or 3 or more drinks in a day.\n\nRisky alcohol use is measured by frequency of any alcohol use, number of usual and maximum drinks in a drinking day, and frequency of drinking 3 or more drinks containing alcohol', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 6 month numbers for each arm (study condition) reflect participant attrition over time'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Weekly Alcohol Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'e-SBI', 'description': "Single session, Electronic SBI for risky alcohol use\n\nElectronic SBI: Bilingual (English and Spanish) e-SBI with four key components:\n\n1\\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."}, {'id': 'OG001', 'title': 'Control', 'description': 'Treatment as usual with only assessment'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.01', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'estimateComment': 'the e-SBI group was at reduced odds relative to the control group to report weekly or more frequent drinking at 6 month follow-up', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, 3 month, 6 month', 'description': 'weekly alcohol use is defined as at least drinking once a week or more often', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '3 and 6 month numbers for each arm (study condition) reflect participant attrition over time'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Heavy Alcohol Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'e-SBI', 'description': "Single session, Electronic SBI for risky alcohol use\n\nElectronic SBI: Bilingual (English and Spanish) e-SBI with four key components:\n\n1\\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."}, {'id': 'OG001', 'title': 'Control', 'description': 'Treatment as usual with only assessment'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'estimateComment': 'the e-SBI group was at reduced odds relative to the control group to report drinking a maximum quantity of 5 or more drinks in a day at 6 month follow-up', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, 3 month, 6 month', 'description': 'heavy alcohol use is defined as self-reported maximum number of drinks in a day of 5 or more drinks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Numbers at 3 and 6 month reflect participant attrition'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Any Tobacco Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'e-SBI', 'description': "Single session, Electronic SBI for risky alcohol use\n\nElectronic SBI: Bilingual (English and Spanish) e-SBI with four key components:\n\n1\\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."}, {'id': 'OG001', 'title': 'Control', 'description': 'Treatment as usual with only assessment'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.10', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'estimateComment': 'the e-SBI group was at reduced odds relative to the control group to report any tobacco use at 6 month follow-up', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline , 3 months, 6 months', 'description': 'Any Tobacco use is measured as any use in the past 3 months of any smoking or chewing tobacco, including cigarettes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'numbers at follow up reflect participant attrition over time'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Frequent Sugar Sweetened Beverage Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'e-SBI', 'description': "Single session, Electronic SBI for risky alcohol use\n\nElectronic SBI: Bilingual (English and Spanish) e-SBI with four key components:\n\n1\\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."}, {'id': 'OG001', 'title': 'Control', 'description': 'Treatment as usual with only assessment'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': '3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.01', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'estimateComment': 'the e-SBI group was at reduced odds relative to the control group to report significant depression at 6 month follow-up', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'Frequent Sugar sweetened beverage use is defined as at least weekly consumption of sugar sweetened beverages', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'numbers at 3 and 6 month reflect participant attrition over time'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Significant Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'e-SBI', 'description': "Single session, Electronic SBI for risky alcohol use\n\nElectronic SBI: Bilingual (English and Spanish) e-SBI with four key components:\n\n1\\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."}, {'id': 'OG001', 'title': 'Control', 'description': 'Treatment as usual, No intervention'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': "Generalized estimating equations (GEE) tested DrinkWise's effects on changes in depression over time controlling for demographic differences between study condition and study sites."}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, 3 months, 6 months', 'description': "Significant depression is measured as scoring above the cutoff of 6 on the total score on the 9 item Physician's health questionnaire (PHQ-9).\n\nThe 9-item Patient Health Questionnaire (PHQ-9) is a self-report measure of depression symptoms in the past two weeks. Scores can range from 0 to 27, with a score of 6 or more indicating significant depression symptoms in samples of childbearing age women.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'numbers at 3 and 6 month reflect participant attrition over time'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Any Drug Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'e-SBI', 'description': "Single session, Electronic SBI for risky alcohol use\n\nElectronic SBI: Bilingual (English and Spanish) e-SBI with four key components:\n\n1\\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."}, {'id': 'OG001', 'title': 'Control', 'description': 'Treatment as usual with only assessment'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '6 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, 3 month, 6 month', 'description': 'Any drug use is defined as use of any substances, e.g., marijuana, stimulants, etc other than tobacco, in the past 3 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'numbers at 3 and 6 month reflect participant attrition over time'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'e-SBI', 'description': "Single session, Electronic Screening and Brief Intervention (SBI) for risky alcohol use\n\nElectronic SBI: Bilingual (English and Spanish) e-SBI with four key components:\n\n1\\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."}, {'id': 'FG001', 'title': 'Control', 'description': 'Treatment as usual with only assessment'}], 'periods': [{'title': 'Baseline Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '3-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}, {'title': '6-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'Participant was assigned to control group but did not complete baseline assessment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'e-SBI', 'description': "Single session, Electronic SBI for risky alcohol use\n\nElectronic SBI: Bilingual (English and Spanish) e-SBI with four key components:\n\n1\\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."}, {'id': 'BG001', 'title': 'Control', 'description': 'Treatment as usual with only assessment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Risky alcohol use', 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Risky alcohol use is defined as drinking 8 or more drinks in a week or 3 or more drinks in a day.\n\nto be enrolled in the trials as risky drinkers, participants had to meet these criteria for risky alcohol use.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-15', 'size': 226944, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-17T14:59', 'hasProtocol': False}, {'date': '2015-06-15', 'size': 1070687, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-12-17T15:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-23', 'studyFirstSubmitDate': '2014-10-21', 'resultsFirstSubmitDate': '2018-12-17', 'studyFirstSubmitQcDate': '2015-01-08', 'lastUpdatePostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-08', 'studyFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting Risky Alcohol Use', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'Risky alcohol use is defined as drinking 8 or more drinks in a week or 3 or more drinks in a day.\n\nRisky alcohol use is measured by frequency of any alcohol use, number of usual and maximum drinks in a drinking day, and frequency of drinking 3 or more drinks containing alcohol'}, {'measure': 'Number of Participants Reporting Weekly Alcohol Use', 'timeFrame': 'baseline, 3 month, 6 month', 'description': 'weekly alcohol use is defined as at least drinking once a week or more often'}, {'measure': 'Number of Participants Reporting Heavy Alcohol Use', 'timeFrame': 'baseline, 3 month, 6 month', 'description': 'heavy alcohol use is defined as self-reported maximum number of drinks in a day of 5 or more drinks'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Reporting Any Tobacco Use', 'timeFrame': 'baseline , 3 months, 6 months', 'description': 'Any Tobacco use is measured as any use in the past 3 months of any smoking or chewing tobacco, including cigarettes'}, {'measure': 'Number of Participants Reporting Frequent Sugar Sweetened Beverage Use', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'Frequent Sugar sweetened beverage use is defined as at least weekly consumption of sugar sweetened beverages'}, {'measure': 'Number of Participants Reporting Significant Depression', 'timeFrame': 'baseline, 3 months, 6 months', 'description': "Significant depression is measured as scoring above the cutoff of 6 on the total score on the 9 item Physician's health questionnaire (PHQ-9).\n\nThe 9-item Patient Health Questionnaire (PHQ-9) is a self-report measure of depression symptoms in the past two weeks. Scores can range from 0 to 27, with a score of 6 or more indicating significant depression symptoms in samples of childbearing age women."}, {'measure': 'Number of Participants Reporting Any Drug Use', 'timeFrame': 'baseline, 3 month, 6 month', 'description': 'Any drug use is defined as use of any substances, e.g., marijuana, stimulants, etc other than tobacco, in the past 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['risky alcohol use', 'pregnancy'], 'conditions': ['Foetal Exposure During Pregnancy']}, 'referencesModule': {'references': [{'pmid': '30882553', 'type': 'DERIVED', 'citation': 'Nayak MB, Kaskutas LA, Mericle AA. Randomized Trial of an Innovative Electronic Screening and Brief Intervention for Reducing Drinking Among Women of Childbearing Age. J Addict Med. 2019 Nov/Dec;13(6):450-459. doi: 10.1097/ADM.0000000000000518.'}]}, 'descriptionModule': {'briefSummary': 'An innovative, self-administered computerized screening and brief intervention (SBI) for drinking during pregnancy will be adapted for use with non-pregnant childbearing age women and its efficacy will be tested in a small trial. Study findings will inform a larger randomized control trial for a primary prevention tool with the potential for broad health impact.', 'detailedDescription': 'This study evaluates a recently piloted, self-administered, computerized tool for reducing prenatal drinking that added novel components of drink size assessment and drink size feedback to traditional screening and brief intervention (SBI). The bilingual (English and Spanish) electronic SBI or "e-SBI" will be adapted for use with non-pregnant women and a small trial of its efficacy will be conducted in two public health clinics. The effects of drink size assessment by itself and of depression as a modifier of e-SBI efficacy will also be studied. Study findings will help design a larger trial of e-SBI\'s efficacy for reducing prenatal alcohol use.\n\nAn experimental design will be used for the proposed small trial. Two hundred women, who have not been pregnant in the past year and report alcohol at risky levels will be randomly assigned to e-SBI or usual care. Participants will complete baseline, 3-month and 6-month follow-up assessments. These assessments will examine drinking and pregnancy as well as possible negative outcomes, such as increased drug use associated with the e-SBI. To address methodological limitations in prior research, the study design incorporates drink size assessment to better measure drinking outcomes, minimizes assessment reactivity for controls at baseline, and includes a booster e-SBI at the 3-month follow up. This allows for the examination of whether drink size assessment reduces drinking by itself and if its effects are equivalent to that of the full e-SBI. With these design innovations, the study is expected to provide information that can be more rigorously assessed in a subsequent multi-arm trial. Because it sets the stage for a Phase II trial of e-SBI efficacy for reducing prenatal alcohol use, our proposed study is of significance for improved maternal and child health. Findings will also impact the larger intervention literature on cost-effective strategies to reduce alcohol-related harm.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* not pregnant in the last 6 months, drank alcohol in the past year, alcohol consumption was at risky levels,\n\nExclusion Criteria:\n\n* not fluent in english or spanish,'}, 'identificationModule': {'nctId': 'NCT02337361', 'briefTitle': 'Computerized Tool for Preventing Prenatal Drinking', 'organization': {'class': 'OTHER', 'fullName': 'Public Health Institute, California'}, 'officialTitle': 'Preparing a Computerized Tool for Preventing Prenatal Drinking for a Larger Trial', 'orgStudyIdInfo': {'id': 'R34AA022697', 'link': 'https://reporter.nih.gov/quickSearch/R34AA022697', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'e-SBI', 'description': 'Single session, Electronic SBI for risky alcohol use', 'interventionNames': ['Behavioral: Electronic SBI']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Treatment as usual with only assessment'}], 'interventions': [{'name': 'Electronic SBI', 'type': 'BEHAVIORAL', 'description': "Bilingual (English and Spanish) e-SBI with four key components:\n\n1\\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.", 'armGroupLabels': ['e-SBI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94601', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'La Clinica Women Infants and Children Program Site', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Sonoma County Department of Health Services', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}], 'overallOfficials': [{'name': 'Madhabika Nayak, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Public Health Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Public Health Institute, California', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sonoma County Department of Health Services', 'class': 'UNKNOWN'}, {'name': 'La Clínica de La Raza Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}