Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-03-02 @ 3:58 PM
Study NCT ID:
NCT02103218
Status:
COMPLETED
Last Update Posted:
2021-06-16
First Post:
2014-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Risky Sex Prevention Intervention for Middle School Age Minority Girls
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lagoble@uncg.edu', 'phone': '336-256-1173', 'title': 'Lisa Goble Director Office of Research Integrity', 'organization': 'UNC Greensboro'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Risky Sex Prevention-Daughters', 'description': 'education, activities, empowerment, racial pride building\n\nEducation, activities, empowerment, racial pride building: Intervention focuses on information aimed toward reducing or preventing risky sex behaviors of minority adolescent females.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Behaviors-Daughters', 'description': 'General health education, activities\n\nGeneral Health education, activities: Intervention focuses on information regarding general health knowledge and healthy behaviors (not including sex).', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Risky Sex Prevention-Mothers', 'description': 'Activities, empowerment', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Healthy Behaviors-Mothers', 'description': 'General health education, activities', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adolescent Sexual Activity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '1.39', 'spread': '.19', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '.19', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '2.12', 'spread': '.33', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'count GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Adolescent Sexual Activity Index (Female). The theoretical minimum and maximum values are min=0 and max=10 (Hansen, Paskett, \\& Carter, 1999). A higher index value indicates more activity (worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'PRIMARY', 'title': 'Any Sex no Condom, Past 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '7.1', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '8.4', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'logistic GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Any sex no condom, past 3 months', 'unitOfMeasure': 'logistic GEE predicted probability as %', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'PRIMARY', 'title': 'Sex With Multiple Partners, Ever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.47', 'groupIds': ['OG000'], 'groupDescription': 'Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'logistic GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Sex with multiple partners, ever', 'unitOfMeasure': 'logistic GEE predicted probability as %', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'PRIMARY', 'title': 'Drugs/Alcohol Use During Sex, Past 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '4.4', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'logistic GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Drugs/Alcohol use during sex, past 3 months', 'unitOfMeasure': 'logistic GEE predicted probability as %', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'SECONDARY', 'title': 'HIV Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '9.8', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '13.1', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'linear GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 month', 'description': 'HIV-Knowledge Questionnaire for Adolescent Girls. The theoretical minimum and maximum values are min=0 and max=18. Higher scores indicate higher HIV knowledge which is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'SECONDARY', 'title': 'Maternal Bond Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '26.9', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '26.8', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '28.9', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Omnibus overall test for any group x time interaction was p = 0.77.', 'groupDescription': 'Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'linear GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Maternal Bond Scale. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate stronger maternal bonds which is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'SECONDARY', 'title': 'Mother-Teen Sexual Risk Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '22.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '22.0', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '25.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '26.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'linear GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Mother-Teen Sexual Risk Communication. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate greater mother-teen communication about sexual risk which is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'SECONDARY', 'title': 'Mother-Adolescent Communication: Open Family Communication (Girl)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '39.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '39.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '37.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '39.2', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'count GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Mother-Adolescent Communication: Open Family Communication (Girl). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'SECONDARY', 'title': 'Maternal Monitoring Scale (Girl)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '34.4', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '35.0', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '34.7', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '35.1', 'spread': '0.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'count GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Maternal Monitoring Scale (Girl). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'SECONDARY', 'title': 'Rosenberg Self-Esteem', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '20.6', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '21.7', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '21.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'linear GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Rosenberg Self-Esteem Scale. The theoretical minimum and maximum values are min=10 and max=40. A higher value indicates higher self-esteem which is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'SECONDARY', 'title': 'Racial Pride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '20.9', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '21.2', 'spread': '0.54', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '22.7', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '0.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'count GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Racial Pride Scale. The theoretical minimum and maximum values are min=7 and max=28. A higher value indicates stronger feelings of racial pride which is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'SECONDARY', 'title': 'Empowerment: Interpersonal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '14.7', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '14.2', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Omnibus overall test for any group x time interaction was p = 0.78.', 'groupDescription': 'Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'count GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=4 and max=20. A higher value indicates greater personal influence on relationship decisions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'SECONDARY', 'title': 'Empowerment: Relationship', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'At 12 months', 'categories': [{'measurements': [{'value': '17.1', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': 'Baseline / Pre-Intervention', 'categories': [{'measurements': [{'value': '16.0', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'count GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater influence over a partner.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'SECONDARY', 'title': 'Empowerment: Personal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'At 12 months', 'categories': [{'measurements': [{'value': '18.2', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '18.3', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Baseline / Pre-Intervention', 'categories': [{'measurements': [{'value': '18.6', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '18.3', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Empowerment Scale: Personal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater personal empowerment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'SECONDARY', 'title': 'Sexual Assertiveness: Refusal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '23.2', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '24.4', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '25.0', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '0.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'count GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Sexual Assertiveness Refusal subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in refusing sexual activity (better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'SECONDARY', 'title': 'Sexual Assertiveness: Prevent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Intervention', 'categories': [{'measurements': [{'value': '26.8', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '25.8', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '27.1', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '26.4', 'spread': '0.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'count GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Sexual Assertiveness Prevent subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in taking measures to prevent pregnancy (better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mother Adolescent Communication: Open Family Communication (Mother)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '41.4', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '41.2', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '41.0', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '41.5', 'spread': '0.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'linear GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Mother Adolescent Communication: Open Family Communication (Mother). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=48 mothers for Risky sex prevention and n=54 mothers for Health behaviors.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maternal Monitoring Scale (Mother)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '37.1', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '37.3', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '37.9', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '37.4', 'spread': '0.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'linear GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Maternal Monitoring Scale (Mother). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=48 mothers for Risky sex prevention and n=54 mothers for Health behaviors.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Communication About Sex Self-Efficacy Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risky Sex Prevention', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'OG001', 'title': 'Healthy Behaviors', 'description': 'General health education, activities'}], 'classes': [{'title': 'Baseline / Pre-Interveniton', 'categories': [{'measurements': [{'value': '56.0', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '55.5', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'At 12 months', 'categories': [{'measurements': [{'value': '57.8', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '58.3', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.', 'statisticalMethod': 'linear GEE', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Communication about Sex Self-Efficacy Scale. The theoretical minimum and maximum scores are min=12 and max=60. Higher scores indicate greater self-efficacy (better outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=48 mothers for Risky sex prevention and n=54 mothers for Health behaviors.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Risky Sex Prevention-Daughters', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'FG001', 'title': 'Healthy Behaviors-Daughters', 'description': 'General health education, activities'}, {'id': 'FG002', 'title': 'Risky Sex Prevention-Mothers', 'description': 'Activities, empowerment, communication...'}, {'id': 'FG003', 'title': 'Healthy Behaviors-Mothers', 'description': 'General health education, activities'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Risky Sex Prevention-Daughters', 'description': 'Education, activities, empowerment, racial pride building...'}, {'id': 'BG001', 'title': 'Healthy Behaviors-Daughters', 'description': 'General health education, activities'}, {'id': 'BG002', 'title': 'Risky Sex Prevention-Mothers', 'description': 'Activities, empowerment, communication.....'}, {'id': 'BG003', 'title': 'Healthy Behaviors-Mothers', 'description': 'General health education, activities'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '12.4', 'spread': '0.70', 'groupId': 'BG000'}, {'value': '12.7', 'spread': '0.94', 'groupId': 'BG001'}, {'value': '40.9', 'spread': '10.3', 'groupId': 'BG002'}, {'value': '37.8', 'spread': '6.39', 'groupId': 'BG003'}, {'value': '25.7', 'spread': '14.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}], 'categories': [{'title': 'African-American', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '164', 'groupId': 'BG004'}]}, {'title': 'Mixed', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': 'Hispanic/Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current Grade', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'title': '6th grade', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG004'}]}, {'title': '7th grade', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG004'}]}, {'title': '8th grade', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only daughters (n=110) were analyzed for middle school grade.'}, {'title': 'Racial Pride', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '21.0', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '21.3', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '21.2', 'spread': '4.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure was not assessed for Mothers.'}, {'title': 'Maternal Monitoring Scale', 'classes': [{'title': 'Daughters only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '34.8', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '35.2', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '35.0', 'spread': '4.2', 'groupId': 'BG004'}]}]}, {'title': 'Mothers only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '37.4', 'spread': '2.6', 'groupId': 'BG002'}, {'value': '37.4', 'spread': '2.2', 'groupId': 'BG003'}, {'value': '37.4', 'spread': '2.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'There are two separate scales: One asked from the perspective of the daughter and one asked from the perspective of the mother. They should be kept separate as has previous literature. For example, they each have their own estimated scale reliability (alpha = .70 for daughters and alpha = .58 for mothers) and should NOT be averaged over daughters and mothers.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Two separate scales: From daughter's perspective and mother's perspective. Should be kept separate like previous literature. They each have their own reliability (alpha = .70 for daughters and .58 for mothers) and should NOT be averaged over daughters and mothers. We therefore present data by 2 rows: (a) for Daughters only and (b) for Mothers only."}, {'title': 'Mother-Adolescent Communication: Open Family Communication', 'classes': [{'title': 'Daughters only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '38.1', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '40.6', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '39.4', 'spread': '8.4', 'groupId': 'BG004'}]}]}, {'title': 'Mothers only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '41.1', 'spread': '5.2', 'groupId': 'BG002'}, {'value': '41.2', 'spread': '5.3', 'groupId': 'BG003'}, {'value': '41.1', 'spread': '5.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'There are two separate scales: One asked from the perspective of the daughter and one asked from the perspective of the mother. They should be kept separate as has previous literature. For example, they each have their own estimated scale reliability (alpha = .87 for daughters and alpha = .70 for mothers) and should NOT be averaged over daughters and mothers. We therefore reported as separate rows for Daughters only and Mothers only.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Two separate scales: One from daughter's perspective and mother's perspective. They should be kept separate like previous literature. They each have their own reliability (alpha = .87 for daughters and alpha = .70 for mothers) and should NOT be averaged over daughters and mothers. We therefore reported as separate by Daughters and Mothers."}, {'title': 'Mother-Teen Sexual Risk Communication', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '24.5', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '24.2', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '24.4', 'spread': '8.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure was only collected for daughters (n=110).'}, {'title': 'HIV Knowledge', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '9.9', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '9.1', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '9.5', 'spread': '2.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure was only collected for daughters (n=110).'}, {'title': 'Maternal Bond Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '26.3', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '27.9', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '27.2', 'spread': '5.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure was only collected for daughters (n=110).'}, {'title': 'Rosenberg Self-Esteem', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '21.0', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '21.8', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '21.5', 'spread': '5.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure was only collected for daughters (n=110).'}, {'title': 'Sexual Assertiveness: Refusal subscale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '23.3', 'spread': '5.2', 'groupId': 'BG000'}, {'value': '23.9', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '23.6', 'spread': '5.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure was only collected for daughters (n=110).'}, {'title': 'Sexual Assertiveness: Prevent subscale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '27.0', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '25.5', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '26.2', 'spread': '4.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure was only collected for daughters (n=110).'}, {'title': 'Empowerment: Interpersonal', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '9.2', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '9.3', 'spread': '2.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure was only collected for daughters (n=110).'}, {'title': 'Empowerment: Relationship', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '7.9', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '8.0', 'spread': '3.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure was only collected for daughters (n=110).'}, {'title': 'Empowerment: Personal', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '18.5', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '18.2', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '18.4', 'spread': '3.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure was only collected for daughters (n=110).'}, {'title': 'Adolescent Sexual Activity Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '1.5', 'spread': '1.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure was only collected for daughters (n=110).'}, {'title': 'Any sex no condom, past 3 months', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This measure was only collected for daughters (n=110).'}, {'title': 'Sex with multiple partners, ever', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This measure was only collected for daughters (n=110).'}, {'title': 'Drugs/Alcohol use during sex, past 3 months', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This measure was only collected for daughters (n=110).'}, {'title': 'Communication about Sex Self-Efficacy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '55.8', 'spread': '5.3', 'groupId': 'BG002'}, {'value': '55.8', 'spread': '5.2', 'groupId': 'BG003'}, {'value': '55.8', 'spread': '5.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "12 items; Cronbach's alpha = .78.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This measure was only collected for mothers (n=102).'}], 'populationDescription': 'The overall number of baseline participants (212) is based on both daughters and mothers in all arms.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-28', 'size': 93961, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-14T12:37', 'hasProtocol': True}, {'date': '2019-01-27', 'size': 163768, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-14T12:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-27', 'studyFirstSubmitDate': '2014-03-31', 'resultsFirstSubmitDate': '2019-01-29', 'studyFirstSubmitQcDate': '2014-04-02', 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-25', 'studyFirstPostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mother Adolescent Communication: Open Family Communication (Mother)', 'timeFrame': '12 months', 'description': 'Mother Adolescent Communication: Open Family Communication (Mother). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome.'}, {'measure': 'Maternal Monitoring Scale (Mother)', 'timeFrame': '12 months', 'description': 'Maternal Monitoring Scale (Mother). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome.'}, {'measure': 'Communication About Sex Self-Efficacy Scale', 'timeFrame': '12 months', 'description': 'Communication about Sex Self-Efficacy Scale. The theoretical minimum and maximum scores are min=12 and max=60. Higher scores indicate greater self-efficacy (better outcome).'}], 'primaryOutcomes': [{'measure': 'Adolescent Sexual Activity Index', 'timeFrame': '12 months', 'description': 'Adolescent Sexual Activity Index (Female). The theoretical minimum and maximum values are min=0 and max=10 (Hansen, Paskett, \\& Carter, 1999). A higher index value indicates more activity (worse outcome).'}, {'measure': 'Any Sex no Condom, Past 3 Months', 'timeFrame': '12 months', 'description': 'Any sex no condom, past 3 months'}, {'measure': 'Sex With Multiple Partners, Ever', 'timeFrame': '12 months', 'description': 'Sex with multiple partners, ever'}, {'measure': 'Drugs/Alcohol Use During Sex, Past 3 Months', 'timeFrame': '12 months', 'description': 'Drugs/Alcohol use during sex, past 3 months'}], 'secondaryOutcomes': [{'measure': 'HIV Knowledge', 'timeFrame': '12 month', 'description': 'HIV-Knowledge Questionnaire for Adolescent Girls. The theoretical minimum and maximum values are min=0 and max=18. Higher scores indicate higher HIV knowledge which is a better outcome.'}, {'measure': 'Maternal Bond Scale', 'timeFrame': '12 months', 'description': 'Maternal Bond Scale. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate stronger maternal bonds which is a better outcome.'}, {'measure': 'Mother-Teen Sexual Risk Communication', 'timeFrame': '12 months', 'description': 'Mother-Teen Sexual Risk Communication. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate greater mother-teen communication about sexual risk which is a better outcome.'}, {'measure': 'Mother-Adolescent Communication: Open Family Communication (Girl)', 'timeFrame': '12 months', 'description': 'Mother-Adolescent Communication: Open Family Communication (Girl). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome.'}, {'measure': 'Maternal Monitoring Scale (Girl)', 'timeFrame': '12 months', 'description': 'Maternal Monitoring Scale (Girl). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome.'}, {'measure': 'Rosenberg Self-Esteem', 'timeFrame': '12 months', 'description': 'Rosenberg Self-Esteem Scale. The theoretical minimum and maximum values are min=10 and max=40. A higher value indicates higher self-esteem which is a better outcome.'}, {'measure': 'Racial Pride', 'timeFrame': '12 months', 'description': 'Racial Pride Scale. The theoretical minimum and maximum values are min=7 and max=28. A higher value indicates stronger feelings of racial pride which is a better outcome.'}, {'measure': 'Empowerment: Interpersonal', 'timeFrame': '12 months', 'description': 'Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=4 and max=20. A higher value indicates greater personal influence on relationship decisions.'}, {'measure': 'Empowerment: Relationship', 'timeFrame': '12 months', 'description': 'Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater influence over a partner.'}, {'measure': 'Empowerment: Personal', 'timeFrame': '12 months', 'description': 'Empowerment Scale: Personal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater personal empowerment.'}, {'measure': 'Sexual Assertiveness: Refusal', 'timeFrame': '12 months', 'description': 'Sexual Assertiveness Refusal subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in refusing sexual activity (better outcome).'}, {'measure': 'Sexual Assertiveness: Prevent', 'timeFrame': '12 months', 'description': 'Sexual Assertiveness Prevent subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in taking measures to prevent pregnancy (better outcome).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'risky sex prevention', 'intervention'], 'conditions': ['HIV', 'Risky Sex Prevention']}, 'referencesModule': {'references': [{'pmid': '23452110', 'type': 'BACKGROUND', 'citation': 'Wallace DC, Bartlett R. Recruitment and retention of African American and Hispanic girls and women in research. Public Health Nurs. 2013 Mar;30(2):159-66. doi: 10.1111/phn.12014. Epub 2012 Nov 22.'}, {'pmid': '29932539', 'type': 'RESULT', 'citation': 'Bartlett R, Johnson A, Randolph I, McCoy TP. Communication and Bonding Between African-American Middle School Girls and Their Maternal Figures. J Natl Black Nurses Assoc. 2016 Jul;27(1):18-23.'}]}, 'descriptionModule': {'briefSummary': 'African American adolescent females are more likely to have sex at an early age, to have older sex partners that have had multiple sexual experiences, and are less likely to use a condom than their white counterparts. Lack of sexual assertiveness is a factor in the risky sex behaviors of young African American women. African American girls at the greatest risk for contracting HIV are the ones that report that their partners could convince them to have sex and report trouble communicating their wishes related to sex. Thus far no intervention has addressed the disparate rate of HIV infection in young African American girls. This study is unique in promoting increases in racial pride as a component of empowerment to help African American girls self-protect against HIV. The study has the potential to empower young African American girls to delay sex initiation or reduce risky sex behaviors and thus reduce their risk of contracting HIV.', 'detailedDescription': 'This is a longitudinal intervention study with a study condition intervention and a control condition intervention. Potential participants will be invited to a recruitment meeting. If they choose to participate, they will be asked to sign informed consent or assent. There are 4 data collections for moms and girls - 1 after recruitment but before the start of the intervention, 1 at the end of the intervention (after the girls 12 week intervention), 1 three months after the end of the intervention (about 6 months after recruitment), and the final data collection 9 months after the end of the intervention (about 12 months from recruitment). Girls are asked to attend 12 group intervention sessions of about 2 hours each, once weekly, and then a final termination session that is followed by a celebration session to which their mothers are invited and then an evaluation session. Moms are asked to participate in 3 one hour education sessions over the 12 weeks that their daughters are in the weekly sessions, the celebration with their daughters, and then their evaluation session. Moms will also be asked to give their daughter empowering messages 5-7 times/week and girls asked to receive them. Finally, moms will be asked to receive calls from the study team once per month or 1 year to be asked about the empowering messages they have been sending their daughters.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Mother Inclusion Criteria:\n\n* Must be 21 years or older.\n* Must be daughter's primary female guardian/caregiver and she lives with me at least 50% of the time.\n* Must understand spoken and written English.\n* Must be able to provide a phone number where they can be reached and will be able to maintain contact with researchers for one year after start of study.\n* Must be able to provide or arrange reliable transportation for their daughter after each session or data collection.\n\nMother Exclusion Criteria:\n\n* Must not be incarcerated at the time of recruitment\n* Must not have a physical or mental health condition that may affect my or my daughter's participation in the study.\n\nDaughter Inclusion Criteria:\n\n* Must be in middle school (grades 6-8) at the time of recruitment.\n* Must be between the ages of 11-14 at the time of recruitment.\n* Must self-identify as Black, African-American, or a mixed race that includes black or African-American.\n* Must be able to understand written and spoken English.\n\nDaughter Exclusion Criteria:\n\n* Must not be in a classroom for developmentally delayed students in school.\n* Must not be currently pregnant at the time of recruitment.\n* Must not have a mental or physical health condition that may affect her participation in the study.\n* Must not be suspended or expelled from school at the time of recruitment."}, 'identificationModule': {'nctId': 'NCT02103218', 'acronym': 'GEMM', 'briefTitle': 'A Risky Sex Prevention Intervention for Middle School Age Minority Girls', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Greensboro'}, 'officialTitle': 'A Risky Sex Prevention Intervention for Middle School Age Minority Girls', 'orgStudyIdInfo': {'id': 'P20MD002289-1'}, 'secondaryIdInfos': [{'id': 'P20MD002289', 'link': 'https://reporter.nih.gov/quickSearch/P20MD002289', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Risky sex prevention', 'description': 'education, activities, empowerment, racial pride building', 'interventionNames': ['Behavioral: Education, activities, empowerment, racial pride building']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy behaviors', 'description': 'General health education, activities', 'interventionNames': ['Behavioral: General Health education, activities']}], 'interventions': [{'name': 'Education, activities, empowerment, racial pride building', 'type': 'BEHAVIORAL', 'description': 'Intervention focuses on information aimed toward reducing or preventing risky sex behaviors of minority adolescent females.', 'armGroupLabels': ['Risky sex prevention']}, {'name': 'General Health education, activities', 'type': 'BEHAVIORAL', 'description': 'Intervention focuses on information regarding general health knowledge and healthy behaviors (not including sex).', 'armGroupLabels': ['Healthy behaviors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27402', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina, Greensboro', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}], 'overallOfficials': [{'name': 'Tracy R Bartlett, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Greensboro'}, {'name': 'Debra C Wallace, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Univeristy of North Carolina, Greensboro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Greensboro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr. Tracy R. Bartlett', 'investigatorAffiliation': 'University of North Carolina, Greensboro'}}}}