Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 1:21 PM
Study NCT ID:
NCT04231669
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2020-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intervention to Improve Developmental and Health Outcomes for Female Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ozge.sensoybahar@wustl.edu', 'phone': '314-935-9403', 'title': 'Dr. Ozge Sensoy Bahar', 'organization': 'Washington University in St. Louis'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '15 months', 'eventGroups': [{'id': 'EG000', 'title': 'Control: Bolstered Care', 'description': 'Female adolescents in the bolstered care will receive services/education as usual in their respective schools. The usual care will be bolstered by providing school notebooks and lunch in the control arm (bolstered care will also be provided to treatment arm). Primary school education is universal and free in Ghana. Yet notebooks and lunch are costly expenses for families that create a barrier to school attendance. Hence, these will be provided to participants in all study schools.', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Anzansi Family Program', 'description': "In addition to bolstered care, participants in this arm will receive the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG).\n\nAnzansi Family Program: the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG). Family EE includes: 1) Workshops on asset building, future planning, and protection from risks; 2) Child Development Account (CDA); and 3) Family income-generating/microenterprise promotion (IGA) component:\n\nMFG a family-centered, group-delivered, evidence-informed intervention designed for children and adolescents whose families struggle with poverty and associated stressors. The MFG is based on building family support through opportunities for parents and children to communicate in a safe setting with other families who have shared experiences, and allow each family to learn from one another. MFG builds protective factors for healthy parent-child relationships while addressing familial, social and community stressors and barriers to adolescent girls' well-being.", 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 0, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intention to Migrate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: Bolstered Care', 'description': 'Female adolescents in the bolstered care will receive services/education as usual in their respective schools. The usual care will be bolstered by providing school notebooks and lunch in the control arm (bolstered care will also be provided to treatment arm). Primary school education is universal and free in Ghana. Yet notebooks and lunch are costly expenses for families that create a barrier to school attendance. Hence, these will be provided to participants in all study schools.'}, {'id': 'OG001', 'title': 'Anzansi Family Program', 'description': "In addition to bolstered care, participants in this arm will receive the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG).\n\nAnzansi Family Program: the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG). Family EE includes: 1) Workshops on asset building, future planning, and protection from risks; 2) Child Development Account (CDA); and 3) Family income-generating/microenterprise promotion (IGA) component:\n\nMFG a family-centered, group-delivered, evidence-informed intervention designed for children and adolescents whose families struggle with poverty and associated stressors. The MFG is based on building family support through opportunities for parents and children to communicate in a safe setting with other families who have shared experiences, and allow each family to learn from one another. MFG builds protective factors for healthy parent-child relationships while addressing familial, social and community stressors and barriers to adolescent girls' well-being."}], 'classes': [{'categories': [{'measurements': [{'value': '1.42', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Linear Mixed-effects regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'post-test (9 months)', 'description': 'Change in intention to migrate will be measured by one question: How likely do you (the adolescent girl) see yourself migrating? The question uses a likert scale ranging from 1 (very unlikely) to 5 (very likely).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Attitudes Towards School', 'timeFrame': 'baseline, post-test (9 month), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in attitudes towards school will be measured by School attitude assessment survey. The range is 20 to 100, with higher scores representing a more positive attitude towards school.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'School Attendance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: Bolstered Care', 'description': 'Female adolescents in the bolstered care will receive services/education as usual in their respective schools. The usual care will be bolstered by providing school notebooks and lunch in the control arm (bolstered care will also be provided to treatment arm). Primary school education is universal and free in Ghana. Yet notebooks and lunch are costly expenses for families that create a barrier to school attendance. Hence, these will be provided to participants in all study schools.'}, {'id': 'OG001', 'title': 'Anzansi Family Program', 'description': "In addition to bolstered care, participants(adolescent girls and caregivers) in this arm will receive the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG).\n\nAnzansi Family Program: the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG). Family EE includes: 1) Workshops on asset building, future planning, and protection from risks; 2) Child Development Account (CDA); and 3) Family income-generating/microenterprise promotion (IGA) component:\n\nMFG a family-centered, group-delivered, evidence-informed intervention designed for children and adolescents whose families struggle with poverty and associated stressors. The MFG is based on building family support through opportunities for parents and children to communicate in a safe setting with other families who have shared experiences, and allow each family to learn from one another. MFG builds protective factors for healthy parent-child relationships while addressing familial, social and community stressors and barriers to adolescent girls' well-being. Both adolecsnt girls and their caregivers will receive the intervention."}], 'classes': [{'title': 'Baseline Baseline', 'categories': [{'title': 'Less than 10%', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Equal to or more than 10%', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'post-test', 'categories': [{'title': 'Less than 10%', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Equal to or more than 10%', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'categories': [{'title': 'Less than 10%', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Equal to or more than 10%', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, post-test (9 month), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in school attendance will be measured by school attendance reports. Number of missed days will be collected', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome only applies to adolescent girls.'}, {'type': 'SECONDARY', 'title': 'Self-concept', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in self-concept will be measured by Tennessee Self-Concept Scale Short Form', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'Life Satisfaction', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'change in life satisfaction will be measured by Multidimensional Student Life Satisfaction Scale', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'Stress', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in stress levels will be measured by Adolescent Stress Questionnaire', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'Family Relationships', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in family relations will be measured by Family Environment Scale', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'Family Functioning', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in family functioning will be measured by Family Assessment Measure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'Social Support', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in social support will be measured by Social Support Behavior Scale', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'Perceived Social Support', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in perceived social support will be measured by Multidimensional Scale of Perceived Social Support', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'Gender Attitudes', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Gender attitudes will be measured by attitudes towards women and gender norm attitudes scales', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'Attitude Towards Work', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Attitudes towards work will be measured by Attitudes towards youth employment scale', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'Savings', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in savings will be measured by Bank statements', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'Future Orientation', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in future orientation will be measured by Thinking about the future measure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}, {'type': 'SECONDARY', 'title': 'Self-esteem', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in self-concept will be measured by Rosenberg self-esteem measure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control: Bolstered Care', 'description': 'Female adolescents in the bolstered care will receive services/education as usual in their respective schools. The usual care will be bolstered by providing school notebooks and lunch in the control arm (bolstered care will also be provided to treatment arm). Primary school education is universal and free in Ghana. Yet notebooks and lunch are costly expenses for families that create a barrier to school attendance. Hence, these will be provided to participants in all study schools.'}, {'id': 'FG001', 'title': 'Anzansi Family Program', 'description': "In addition to bolstered care, participants in this arm will receive the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG).\n\nAnzansi Family Program: the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG). Family EE includes: 1) Workshops on asset building, future planning, and protection from risks; 2) Child Development Account (CDA); and 3) Family income-generating/microenterprise promotion (IGA) component:\n\nMFG a family-centered, group-delivered, evidence-informed intervention designed for children and adolescents whose families struggle with poverty and associated stressors. The MFG is based on building family support through opportunities for parents and children to communicate in a safe setting with other families who have shared experiences, and allow each family to learn from one another. MFG builds protective factors for healthy parent-child relationships while addressing familial, social and community stressors and barriers to adolescent girls' well-being."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '100'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '100'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '6'}]}]}], 'typeUnitsAnalyzed': 'schools'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control: Bolstered Care', 'description': 'Female adolescents in the bolstered care will receive services/education as usual in their respective schools. The usual care will be bolstered by providing school notebooks and lunch in the control arm (bolstered care will also be provided to treatment arm). Primary school education is universal and free in Ghana. Yet notebooks and lunch are costly expenses for families that create a barrier to school attendance. Hence, these will be provided to participants in all study schools.'}, {'id': 'BG001', 'title': 'Anzansi Family Program', 'description': "In addition to bolstered care, participants in this arm will receive the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG).\n\nAnzansi Family Program: the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG). Family EE includes: 1) Workshops on asset building, future planning, and protection from risks; 2) Child Development Account (CDA); and 3) Family income-generating/microenterprise promotion (IGA) component:\n\nMFG a family-centered, group-delivered, evidence-informed intervention designed for children and adolescents whose families struggle with poverty and associated stressors. The MFG is based on building family support through opportunities for parents and children to communicate in a safe setting with other families who have shared experiences, and allow each family to learn from one another. MFG builds protective factors for healthy parent-child relationships while addressing familial, social and community stressors and barriers to adolescent girls' well-being."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}], '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': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The numbers reported in the overall number of baseline participants correspond to caregivers and adolescents together.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The total number is the sum of caregivers and adolescent girls.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-14', 'size': 358451, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-15T10:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2020-01-08', 'resultsFirstSubmitDate': '2022-11-22', 'studyFirstSubmitQcDate': '2020-01-13', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-15', 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intention to Migrate', 'timeFrame': 'post-test (9 months)', 'description': 'Change in intention to migrate will be measured by one question: How likely do you (the adolescent girl) see yourself migrating? The question uses a likert scale ranging from 1 (very unlikely) to 5 (very likely).'}], 'secondaryOutcomes': [{'measure': 'Attitudes Towards School', 'timeFrame': 'baseline, post-test (9 month), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in attitudes towards school will be measured by School attitude assessment survey. The range is 20 to 100, with higher scores representing a more positive attitude towards school.'}, {'measure': 'School Attendance', 'timeFrame': 'baseline, post-test (9 month), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in school attendance will be measured by school attendance reports. Number of missed days will be collected'}, {'measure': 'Self-concept', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in self-concept will be measured by Tennessee Self-Concept Scale Short Form'}, {'measure': 'Life Satisfaction', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'change in life satisfaction will be measured by Multidimensional Student Life Satisfaction Scale'}, {'measure': 'Stress', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in stress levels will be measured by Adolescent Stress Questionnaire'}, {'measure': 'Family Relationships', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in family relations will be measured by Family Environment Scale'}, {'measure': 'Family Functioning', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in family functioning will be measured by Family Assessment Measure'}, {'measure': 'Social Support', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in social support will be measured by Social Support Behavior Scale'}, {'measure': 'Perceived Social Support', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in perceived social support will be measured by Multidimensional Scale of Perceived Social Support'}, {'measure': 'Gender Attitudes', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Gender attitudes will be measured by attitudes towards women and gender norm attitudes scales'}, {'measure': 'Attitude Towards Work', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Attitudes towards work will be measured by Attitudes towards youth employment scale'}, {'measure': 'Savings', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in savings will be measured by Bank statements'}, {'measure': 'Future Orientation', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in future orientation will be measured by Thinking about the future measure'}, {'measure': 'Self-esteem', 'timeFrame': 'baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)', 'description': 'Change in self-concept will be measured by Rosenberg self-esteem measure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['child migration', 'child labor', 'sub-Saharan Africa', 'female adolescents'], 'conditions': ['Independent Child Migration']}, 'referencesModule': {'references': [{'pmid': '33372647', 'type': 'DERIVED', 'citation': 'Sensoy Bahar O, Ssewamala FM, Ibrahim A, Boateng A, Nabunya P, Neilands TB, Asampong E, McKay MM. Anzansi family program: a study protocol for a combination intervention addressing developmental and health outcomes for adolescent girls at risk of unaccompanied migration. Pilot Feasibility Stud. 2020 Dec 7;6(1):190. doi: 10.1186/s40814-020-00737-4.'}]}, 'descriptionModule': {'briefSummary': "The primary goal of this pilot study (R21) is to address the urgent need for theoretically and empirically informed interventions that prevent poor female youth's rural-to-urban migration for child labor in low and middle-income countries. The study will address the following specific aims: Aim 1: Pilot test the (i) feasibility and acceptability of ANZANSI; and (ii) preliminary impact of ANZANSI by comparing the control arm to the treatment arm on specific child development outcomes; Aim 2: Explore multi- level factors (individual, family, and programmatic) impacting participation in and experiences with the ANZANSI.", 'detailedDescription': "The primary goal of this pilot study (R21) is to address the urgent need for theoretically and empirically informed interventions that prevent poor female youth's rural-to-urban migration for child labor in low and middle-income countries. The International Labor Organization (ILO) estimates that 11% of children (ages 5 to 17) worldwide are child laborers. ILO recently drew attention to migrant child laborers as an underreported, but more vulnerable group to adverse outcomes relative to children working locally. Sub-Saharan Africa (SSA) continues to be the continent with the highest rates of child labor, with Ghana registering one of the highest incidence rates at 22%, including unaccompanied child migrants engaged in labor. Adolescent girls make up the majority of unaccompanied rural-to-urban migrants in search of better economic opportunities. Studies document the myriad of serious threats to health and emotional well-being experienced by female adolescent migrants engaged in child labor. These threats underline the urgent need for theoretically-informed preventive interventions, specifically tailored to address the root causes of female child migrant labor and the needs of girls from economically insecure families and communities. Hence, this application titled ANZANSI Family Program focuses on girls before they drop out of school, but as they begin exhibiting possibility of dropping out. Specifically, ANZANSI is an innovative combination intervention program, combining an evidence-informed family-level economic empowerment (EE) aimed at creating and strengthening financial stability through the use of matched children savings accounts (CSA) and microfinance in poor households with a multiple family group (MFG) intervention addressing family functioning and parental beliefs around gender and child labor/ education. Informed by asset theory, parental ethnotheories framework; and the investigative team's research in SSA on child-wellbeing and poverty, the study uses a cluster randomized control design (N=10 schools; n=100 girls ages 11-14 at risk of dropping out of school and their caregivers), assigned to two study conditions (N= 5 schools; n=50 children at risk of dropping out of school and their caregivers in each condition). The control group will receive bolstered usual care, including books and school lunch and treatment group will receive a combination intervention (Family EE+MFG) called ANZANSI, to address the following specific aims: Aim 1: Pilot test the (i) feasibility and acceptability of ANZANSI; and (ii) preliminary impact of ANZANSI by comparing the control arm to the treatment arm on specific child development outcomes; Aim 2: Explore multi- level factors (individual, family, and programmatic) impacting participation in and experiences with the ANZANSI. This study is aligned with NICHD's mission to support research relevant to the psychological, behavioral, and educational development and health of children worldwide. Ultimately, our findings may guide approaches to address youth's unaccompanied rural-to-urban migration and involvement in child labor in SSA, and the associated negative consequences."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nAdolescent girls' inclusion criteria are:\n\n* Enrolled in school and living within a family (defined broadly -not necessarily biological parents)\n* Ages 11 to 14\n* Capable of giving assent\n* Skipping school in the past academic term (with at least 10% of unexcused absences).\n\nThe caregiver inclusion criteria are:\n\n* Self-identified as primary caregiver of the adolescent girl\n* Capable of providing informed consent.\n\nExclusion Criteria:\n\n* Participants (girls and caregivers) that do not meet the criteria or exhibit a lack of understanding of the study procedures and hence not able to provide informed consent will be excluded."}, 'identificationModule': {'nctId': 'NCT04231669', 'briefTitle': 'Intervention to Improve Developmental and Health Outcomes for Female Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Intervention to Improve Developmental and Health Outcomes for Female Adolescents', 'orgStudyIdInfo': {'id': 'R21HD099508', 'link': 'https://reporter.nih.gov/quickSearch/R21HD099508', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control: bolstered care', 'description': 'Female adolescents in the bolstered care will receive services/education as usual in their respective schools. The usual care will be bolstered by providing school notebooks and lunch in the control arm (bolstered care will also be provided to treatment arm). Primary school education is universal and free in Ghana. Yet notebooks and lunch are costly expenses for families that create a barrier to school attendance. Hence, these will be provided to participants in all study schools.'}, {'type': 'EXPERIMENTAL', 'label': 'Anzansi Family Program', 'description': 'In addition to bolstered care, participants(adolescent girls and caregivers) in this arm will receive the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG).', 'interventionNames': ['Behavioral: Anzansi Family Program']}], 'interventions': [{'name': 'Anzansi Family Program', 'type': 'BEHAVIORAL', 'description': "the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG). Family EE includes: 1) Workshops on asset building, future planning, and protection from risks; 2) Child Development Account (CDA); and 3) Family income-generating/microenterprise promotion (IGA) component:\n\nMFG a family-centered, group-delivered, evidence-informed intervention designed for children and adolescents whose families struggle with poverty and associated stressors. The MFG is based on building family support through opportunities for parents and children to communicate in a safe setting with other families who have shared experiences, and allow each family to learn from one another. MFG builds protective factors for healthy parent-child relationships while addressing familial, social and community stressors and barriers to adolescent girls' well-being. Both adolecsnt girls and their caregivers will receive the intervention.", 'armGroupLabels': ['Anzansi Family Program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Accra', 'country': 'Ghana', 'facility': 'University of Ghana', 'geoPoint': {'lat': 5.55602, 'lon': -0.1969}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ghana', 'class': 'OTHER'}, {'name': 'BasicNeeds Ghana', 'class': 'OTHER'}, {'name': 'BIBIR Ghana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}