Viewing Study NCT03284112


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Ignite Modification Date: 2026-03-26 @ 6:47 AM
Study NCT ID: NCT03284112
Status: COMPLETED
Last Update Posted: 2025-10-23
First Post: 2017-09-12
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Old SCHOOL Hip-Hop: Improve Alzheimer's Disease Knowledge
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jn2054@columbia.edu', 'phone': '212-342-4126', 'title': 'Dr. James M. Noble', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, up to 24 weeks.', 'description': "Undue psychological burden on child or child being upset due to discussing Alzheimer's Disease", 'eventGroups': [{'id': 'EG000', 'title': 'Control Students', 'description': 'School population without the Old SCHOOL Hip-Hop program, but with the My Plate program.\n\nMy Plate: The program selected for the control arm, "My Plate," will address nutrition, physical activity, and obesity education. This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive. Trained facilitators will conduct "My Plate" as an entry point for the USDA\'s My Plate nutrition program. Students will learn about My Plate across the 3-day one-hour-a-day program.', 'otherNumAtRisk': 774, 'deathsNumAtRisk': 774, 'otherNumAffected': 0, 'seriousNumAtRisk': 774, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention Students', 'description': 'School population with the Old SCHOOL Hip-Hop program.\n\nOld SCHOOL Hip-Hop: A school-based intervention called "Old S.C.H.O.O.L. Hip-Hop" (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions). The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and family dementia literacy.', 'otherNumAtRisk': 687, 'deathsNumAtRisk': 687, 'otherNumAffected': 0, 'seriousNumAtRisk': 687, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Control Parents', 'description': 'Parents of school population without the Old SCHOOL Hip-Hop program, but with the My Plate program.\n\nMy Plate: The program selected for the control arm, "My Plate," will address nutrition, physical activity, and obesity education. This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive. Trained facilitators will conduct "My Plate" as an entry point for the USDA\'s My Plate nutrition program. Students will learn about My Plate across the 3-day one-hour-a-day program.', 'otherNumAtRisk': 401, 'deathsNumAtRisk': 401, 'otherNumAffected': 0, 'seriousNumAtRisk': 401, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Intervention Parents', 'description': 'Parents of school population with the Old SCHOOL Hip-Hop program. Old SCHOOL Hip-Hop: A school-based intervention called "Old S.C.H.O.O.L. Hip-Hop" (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions). The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and familv dementia literacy.', 'otherNumAtRisk': 382, 'deathsNumAtRisk': 382, 'otherNumAffected': 0, 'seriousNumAtRisk': 382, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'OSHH Program Effectiveness of Educating Parents at 1-week and 3-months After the Intervention Using ASK-AD 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}, {'value': '382', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'School population without the Old SCHOOL Hip-Hop program, but with the My Plate program.\n\nMy Plate: The program selected for the control arm, "My Plate," will address nutrition, physical activity, and obesity education. This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive. Trained facilitators will conduct "My Plate" as an entry point for the USDA\'s My Plate nutrition program. Students will learn about My Plate across the 3-day one-hour-a-day program.'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'School population with the Old SCHOOL Hip-Hop program.\n\nOld SCHOOL Hip-Hop: A school-based intervention called "Old S.C.H.O.O.L. Hip-Hop" (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions). The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and family dementia literacy.'}], 'classes': [{'title': 'Pre-Test (1 week prior to intervention)', 'categories': [{'measurements': [{'value': '5.14', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '5.28', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Post-Test (1-week post intervention)', 'categories': [{'measurements': [{'value': '5.41', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '5.62', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Delayed Post-Test (3-months post intervention)', 'categories': [{'measurements': [{'value': '5.68', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '5.95', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (1 week up to 15 weeks prior to Intervention Day 1), 1-week post-intervention (1 week up to 13 weeks post-Intervention Day 3, but always before 3-month intervention), and 3-months post-intervention (10 to 24 weeks post-intervention Day 1)', 'description': "OSHH Program effectiveness of educating parents at 1-week post and 3-months post intervention using a 7-item scale: ASK-AD 7 (Assess Symptoms and Knowledge of Alzheimer's Disease - 7 Questions). Minimum value is 0 and maximum value is 7. Higher scores indicate greater number of questions answered correctly, indicating a better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Parents whose children participated in either Control Arm (MyPlate Program) or Intervention Arm (Old School Hip Hop Program) and who consented to participate in the survey.'}, {'type': 'SECONDARY', 'title': 'OSHH Program Effectiveness of Educating Students at Immediate-post and 3-months Post the Intervention Using ASK-AD 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: Students', 'description': 'School population without the Old SCHOOL Hip-Hop program, but with the My Plate program.\n\nMy Plate: The program selected for the control arm, "My Plate," will address nutrition, physical activity, and obesity education. This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive. Trained facilitators will conduct "My Plate" as an entry point for the USDA\'s My Plate nutrition program. Students will learn about My Plate across the 3-day one-hour-a-day program.'}, {'id': 'OG001', 'title': 'Intervention: Students', 'description': 'School population with the Old SCHOOL Hip-Hop program.\n\nOld SCHOOL Hip-Hop: A school-based intervention called "Old S.C.H.O.O.L. Hip-Hop" (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions). The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and family dementia literacy.'}], 'classes': [{'title': 'Pre-test (Immediately Before Intervention)', 'categories': [{'measurements': [{'value': '3.13', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '3.36', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Post-Test (Immediately Post Intervention)', 'categories': [{'measurements': [{'value': '3.67', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '5.02', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Delayed Post-Test (3-months post intervention)', 'categories': [{'measurements': [{'value': '4.21', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '6.69', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately before intervention began (On Day 1 of programming), Immediately post intervention (Day 3 of programming), 3-months post intervention (6 up to 20 weeks post Day 1 of programming)', 'description': "OSHH Program effectiveness of educating students immediately-post and 3-months post the intervention using a 7-item scale: ASK-AD 7 (Assess Symptoms and Knowledge of Alzheimer's Disease - 7 Questions). Minimum value is 0 and maximum value is 7. Higher scores indicate greater number of questions answered correctly, indicating a better outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Students randomized into either Control Arm (My Plate program) or Intervention Arm (Old School Hip Hop program)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Students & Parents', 'description': 'School \\& parent population without the Old SCHOOL Hip-Hop program, but with the My Plate program.\n\nMy Plate: The program selected for the control arm, "My Plate," will address nutrition, physical activity, and obesity education. This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive. Trained facilitators will conduct "My Plate" as an entry point for the USDA\'s My Plate nutrition program. Students will learn about My Plate across the 3-day one-hour-a-day program.'}, {'id': 'FG001', 'title': 'Intervention Students & Parents', 'description': 'School \\& parent population with the Old SCHOOL Hip-Hop program.\n\nOld SCHOOL Hip-Hop: A school-based intervention called "Old S.C.H.O.O.L. Hip-Hop" (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions). The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and family dementia literacy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '14', 'numSubjects': '1175'}, {'groupId': 'FG001', 'numUnits': '14', 'numSubjects': '1069'}]}, {'type': 'Parents Started', 'achievements': [{'groupId': 'FG000', 'numUnits': '14', 'numSubjects': '401'}, {'groupId': 'FG001', 'numUnits': '14', 'numSubjects': '382'}]}, {'type': 'Children Started', 'achievements': [{'groupId': 'FG000', 'numUnits': '14', 'numSubjects': '774'}, {'groupId': 'FG001', 'numUnits': '14', 'numSubjects': '687'}]}, {'type': 'Parents Completed', 'achievements': [{'groupId': 'FG000', 'numUnits': '14', 'numSubjects': '344'}, {'groupId': 'FG001', 'numUnits': '14', 'numSubjects': '349'}]}, {'type': 'Children Completed', 'achievements': [{'groupId': 'FG000', 'numUnits': '14', 'numSubjects': '741'}, {'groupId': 'FG001', 'numUnits': '14', 'numSubjects': '665'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '14', 'numSubjects': '1085'}, {'groupId': 'FG001', 'numUnits': '14', 'numSubjects': '1014'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '90'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '55'}]}]}], 'typeUnitsAnalyzed': 'Schools', 'recruitmentDetails': 'NYC schools were recruited \\& enrolled from September 9, 2018 through February 27, 2023. Once each school agreed to participate, parents \\& students were recruited. Then each school was randomized into either Control or Intervention arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Students', 'description': 'School population without the Old SCHOOL Hip-Hop program, but with the My Plate program.\n\nMy Plate: The program selected for the control arm, "My Plate," will address nutrition, physical activity, and obesity education. This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive. Trained facilitators will conduct "My Plate" as an entry point for the USDA\'s My Plate nutrition program. Students will learn about My Plate across the 3-day one-hour-a-day program.'}, {'id': 'BG001', 'title': 'Intervention Students', 'description': 'School population with the Old SCHOOL Hip-Hop program.\n\nOld SCHOOL Hip-Hop: A school-based intervention called "Old S.C.H.O.O.L. Hip-Hop" (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions). The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and family dementia literacy.'}, {'id': 'BG002', 'title': 'Control Parents', 'description': 'Parents of school population without the Old SCHOOL Hip-Hop program, but with the My Plate program.\n\nMy Plate: The program selected for the control arm, "My Plate," will address nutrition, physical activity, and obesity education. This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive. Trained facilitators will conduct "My Plate" as an entry point for the USDA\'s My Plate nutrition program. Students will learn about My Plate across the 3-day one-hour-a-day program.'}, {'id': 'BG003', 'title': 'Intervention Parents', 'description': 'Parents of school population with the Old SCHOOL Hip-Hop program. Old SCHOOL Hip-Hop: A school-based intervention called "Old S.C.H.O.O.L. Hip-Hop" (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions). The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and familv dementia literacy.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1461', 'groupId': 'BG004'}]}]}, {'title': '18-64 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}, {'value': '369', 'groupId': 'BG003'}, {'value': '756', 'groupId': 'BG004'}]}]}, {'title': '>=65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'Unknown/Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '362', 'groupId': 'BG000'}, {'value': '374', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}, {'value': '325', 'groupId': 'BG003'}, {'value': '1415', 'groupId': 'BG004'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '334', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '697', 'groupId': 'BG004'}]}]}, {'title': 'Unknown/Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '132', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '232', 'groupId': 'BG003'}, {'value': '813', 'groupId': 'BG004'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '187', 'groupId': 'BG004'}]}]}, {'title': 'Unknown/Not Reported (Other)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '544', 'groupId': 'BG000'}, {'value': '426', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '1184', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '408', 'groupId': 'BG004'}]}]}, {'title': 'Not Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}, {'value': '267', 'groupId': 'BG003'}, {'value': '998', 'groupId': 'BG004'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '450', 'groupId': 'BG000'}, {'value': '355', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '838', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '2244', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Baseline Alzheimer's Disease Knowledge Using ASK-AD 7", 'classes': [{'title': 'Students Pre-Test: Immediately Before Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '774', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1461', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2.98', 'spread': '1.93', 'groupId': 'BG000'}, {'value': '2.75', 'spread': '1.97', 'groupId': 'BG001'}, {'value': '2.87', 'spread': '1.95', 'groupId': 'BG004'}]}]}, {'title': 'Parents Pre-Test: Before Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}, {'value': '783', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5.13', 'spread': '1.77', 'groupId': 'BG002'}, {'value': '5.24', 'spread': '1.70', 'groupId': 'BG003'}, {'value': '5.18', 'spread': '1.74', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "Baseline Knowledge of Alzheimer's Disease using 7-item scale: ASK-AD 7 (Assess Symptoms and Knowledge of Alzheimer's Disease - 7 Questions). Minimum value is 0 and maximum value is 7. Higher scores indicate greater number of questions answered correctly, indicating a better outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Each row indicates parents \\& students which were treated as two separate groups. The number of parents + number of students who completed a baseline measure = overall population.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-04-16', 'size': 552747, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-04T14:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2017-09-12', 'resultsFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-08', 'studyFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OSHH Program Effectiveness of Educating Parents at 1-week and 3-months After the Intervention Using ASK-AD 7', 'timeFrame': 'Baseline (1 week up to 15 weeks prior to Intervention Day 1), 1-week post-intervention (1 week up to 13 weeks post-Intervention Day 3, but always before 3-month intervention), and 3-months post-intervention (10 to 24 weeks post-intervention Day 1)', 'description': "OSHH Program effectiveness of educating parents at 1-week post and 3-months post intervention using a 7-item scale: ASK-AD 7 (Assess Symptoms and Knowledge of Alzheimer's Disease - 7 Questions). Minimum value is 0 and maximum value is 7. Higher scores indicate greater number of questions answered correctly, indicating a better outcome."}], 'secondaryOutcomes': [{'measure': 'OSHH Program Effectiveness of Educating Students at Immediate-post and 3-months Post the Intervention Using ASK-AD 7', 'timeFrame': 'Immediately before intervention began (On Day 1 of programming), Immediately post intervention (Day 3 of programming), 3-months post intervention (6 up to 20 weeks post Day 1 of programming)', 'description': "OSHH Program effectiveness of educating students immediately-post and 3-months post the intervention using a 7-item scale: ASK-AD 7 (Assess Symptoms and Knowledge of Alzheimer's Disease - 7 Questions). Minimum value is 0 and maximum value is 7. Higher scores indicate greater number of questions answered correctly, indicating a better outcome."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dementia, Schools, Nutrition, Health'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate the knowledge of parents and children with respect to dementia symptoms, risk factors, and response before and after an interactive dementia education program that uses music and dance to enhance a health education curriculum at 1-week and 3-months after the intervention.', 'detailedDescription': "Public awareness of cardinal Alzheimer's disease (AD) symptoms remains low. Adults often underestimate personal dementia risk; minority populations are more likely to have low dementia literacy and be unaware of it. Cultural dementia belief in minority groups are complex and pose barriers to diagnosis, with dementia symptoms being considered a part of normal aging, or that discussion may be taboo even when recognized. A key barrier to timely AD diagnosis in African Americans is delayed physician contact, often years-long, following the onset of first symptoms. Despite studies demonstrating that dementia concepts first develop in elementary school periods, apart from our work, no dementia awareness programs focus on children. This intervention therefore addresses a major gap regarding optimal approaches for shifting cultural perceptions of dementia in low-income minority populations and reducing barriers to its timely diagnosis.\n\nAll R01 aims have been completed in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 4th and 5th-grade children (ages 9-11y) and their parents (age \\> 20 years).\n* Selected New York City public schools with similar socio-demographic composition.\n\nExclusion Criteria:\n\n* Schools have already received pilot OSHH and the U.S. Department of Health and Human Services (HHS) programming.'}, 'identificationModule': {'nctId': 'NCT03284112', 'briefTitle': "Old SCHOOL Hip-Hop: Improve Alzheimer's Disease Knowledge", 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': "Old SCHOOL Hip-Hop: A Randomized Controlled Trial to Improve Alzheimer's Disease Knowledge", 'orgStudyIdInfo': {'id': 'AAAR5473'}, 'secondaryIdInfos': [{'id': '5R01AG054536', 'link': 'https://reporter.nih.gov/quickSearch/5R01AG054536', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'School population without the Old SCHOOL Hip-Hop program, but with the My Plate program.', 'interventionNames': ['Behavioral: My Plate']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'School population with the Old SCHOOL Hip-Hop program.', 'interventionNames': ['Behavioral: Old SCHOOL Hip-Hop']}], 'interventions': [{'name': 'Old SCHOOL Hip-Hop', 'type': 'BEHAVIORAL', 'otherNames': ['OSHH Program'], 'description': 'A school-based intervention called "Old S.C.H.O.O.L. Hip-Hop" (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions). The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and family dementia literacy.', 'armGroupLabels': ['Intervention']}, {'name': 'My Plate', 'type': 'BEHAVIORAL', 'otherNames': ['My Plate nutrition program'], 'description': 'The program selected for the control arm, "My Plate," will address nutrition, physical activity, and obesity education. This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive. Trained facilitators will conduct "My Plate" as an entry point for the USDA\'s My Plate nutrition program. Students will learn about My Plate across the 3-day one-hour-a-day program.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'James Noble, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology in the Taub Institute and the Sergievsky Center, Department of Neurology - Aging & Dementia', 'investigatorFullName': 'James M Noble, MD, MS, CPH, FAAN', 'investigatorAffiliation': 'Columbia University'}}}}