Alzheimer DiseaseNCT06699589
Old School Hip Hop: Parent Follow-Up & Spanish Speakers Inclusion
A study testing Old SCHOOL Hip-Hop (Dementia Education) and My Plate (Nutrition Education) in people with Alzheimer Disease and Dementia, run by Columbia University at 1 site in United States.
Trial summary
These are the exploratory aims of the original trial cohort study "Old School Hip Hop RCT (AAAR5473)," which recruited 783 parents. 1. Continued follow-up of these families to learn more about the durability of the program through similar assessments to those used during the pre-specified 3-month initial study… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- Old SCHOOL Hip-Hop (Dementia Education) and My Plate (Nutrition Education)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2019to 4 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent that participated in the OSHH Trial
- Parent that expressed interest in participating, but originally excluded from OSHH Trial due to language barrier
Who cannot join
- Did not have a participating child in OSHH Trial
Trial locations and contacts
1 site in 1 country.
About this study
These are the exploratory aims of the original trial cohort study "Old School Hip Hop RCT (AAAR5473)," which recruited 783 parents.
- Continued follow-up of these families to learn more about the durability of the program through similar assessments to those used during the pre-specified 3-month initial study timeframe - aiming to understand participant knowledge and personal experiences with family members or friends affected by Alzheimer's Disease (AD).
- Further examining the degree of comfort with dementia, as measured by a simplified version of the Dementia Attitudes Scale (DAS) focused on observable behaviors in children by their parents - aiming to understand the extent of stigmatization of dementia in communities served by this program, and if the trial impacted evidence of stigma.
- Enrolling up to 75 parents who primarily spoke Spanish who were originally contacted in the RCT but were not eligible for completion of the original round of surveys given that all study materials were in English. This approach aims to better understand the impact of the program and Alzheimer disease on these families.
Read more
Hypothesis 1: For the delayed follow-up with parents, the investigator anticipates that those with high dementia literacy or the largest dementia literacy improvement would sustain knowledge over 15-month period.
Hypothesis 2: Children who received the intervention arm of the trial, who also have regular contact with a close friend or family member with dementia, will demonstrate positive dementia attitudes relative to students in the control arm.
Hypothesis 3: Semi-structured interviews with Spanish speaking families will help program capacity to better serve the population and improve involvement in AD care and research.
Read the detailed description
The goal of the R01 study is to educate children and thereby parents/guardians on health education content through live educators, music, and videos. The study curriculum focuses on healthy aging vs Dementia/Alzheimer's Disease (AD), nutrition, and overall health. The investigator wishes to learn if children are able to absorb these health topics and share what they learn with their parents/guardians. That part of the program has been completed with students. This non-R01 portion of the study is designed to look at the long-term effect of the program, how it may have affected Spanish speaking families that were not approached during the first portion.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- Old SCHOOL Hip-Hop (Dementia Education), My Plate (Nutrition Education)
- Keywords
- dementia, schools, nutrition, health education
- Medical subject headings
- Alzheimer Disease, Dementia, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Old SCHOOL Hip-Hop (Dementia Education)Behavioural
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.
My Plate (Nutrition Education)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | School population without the Old SCHOOL Hip-Hop program, but with the My Plate program. Receives: Behavioral: My Plate (Nutrition Education) |
| Intervention | Experimental | School population with the Old SCHOOL Hip-Hop program. Receives: Behavioral: Old SCHOOL Hip-Hop (Dementia Education) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Dementia Symptom and Response Knowledge Assessment Score
An instrument with multiple choice questions to assess knowledge of recognition of key signs/symptoms and ability to formulate the correct action plan in response to recognizing dementia. Parents were asked knowledge questions at three timepoints in main trial. This additional fourth time point would capture any changes in delayed knowledge retention (starting at 15-Months post baseline data collection).
Measured: From 15 to 48 months post baseline data collection
Spanish Dementia Symptom and Response Knowledge Assessment Score (Spanish Speaking Parents)
Spanish Translated instrument with multiple choice questions to assess knowledge of recognition of key signs/symptoms and ability to formulate the correct action plan in response to recognizing dementia.
Measured: From 2.5 to 6 years post student baseline collection
Secondary outcomes (3)
Spanish Parent Semi-Structured Interview
Spanish Speaking parents were ineligible to complete baseline surveys related to language barriers in earlier program phase materials. This semi-structured interview aims to learn how to better serve this population when it comes to dementia education and research.
Measured: From 2.5 to 6 years post student baseline collection
Adapted Dementia Attitude Scale for Children & Parents
An adapted instrument with multiple choice questions to assess parent and child dementia attitudes (comfort/stigma) post-program. At least 15 up to 48 months post baseline data collection.
Measured: From 15 to 48 months post baseline data collection
Spanish Adapted Dementia Attitude Scale for Children & Parents (Spanish Speaking Parents)
A translated adapted instrument with multiple choice questions to assess parent and child dementia attitudes (comfort/stigma).
Measured: From 2.5 to 6 years post student baseline collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start11 Sep 2019
- Primary completion4 Mar 2025
- Study completion4 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James M Noble, MD, MS, CPH, FAAN, Columbia University
- Investigators
- James M Noble, MD, Principal investigator, Associate Professor, Taub Institute, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699589
- Sponsor's protocol ID
- AAAR5473 - non-R01
- Status last verified
- Jun 2025
- First submitted
- 19 Nov 2024
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Old School Hip Hop: Parent Follow-Up & Spanish Speakers Inclusion
- ClinicalTrials.gov ID
- NCT06699589
- Acronym / sponsor ID
- AAAR5473 - non-R01
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- dementia, schools, nutrition, health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
These are the exploratory aims of the original trial cohort study "Old School Hip Hop RCT (AAAR5473)," which recruited 783 parents.
- Continued follow-up of these families to learn more about the durability of the program through similar assessments to those used during the pre-specified 3-month initial study timeframe - aiming to understand participant knowledge and personal experiences with family members or friends affected by Alzheimer's Disease (AD).
- Further examining the degree of comfort with dementia, as measured by a simplified version of the Dementia Attitudes Scale (DAS) focused on observable behaviors in children by their parents - aiming to understand the extent of stigmatization of dementia in communities served by this program, and if the trial impacted evidence of stigma.
- Enrolling up to 75 parents who primarily spoke Spanish who were originally contacted in the RCT but were not eligible for completion of the original round of surveys given that all study materials were in English. This approach aims to better understand the impact of the program and Alzheimer disease on these families.
Hypothesis 1: For the delayed follow-up with parents, the investigator anticipates that those with high dementia literacy or the largest dementia literacy improvement would sustain knowledge over 15-month period.
Hypothesis 2: Children who received the intervention arm of the trial, who also have regular contact with a close friend or family member with dementia, will demonstrate positive dementia attitudes relative to students in the control arm.
Hypothesis 3: Semi-structured interviews with Spanish speaking families will help program capacity to better serve the population and improve involvement in AD care and research.
Detailed description
The goal of the R01 study is to educate children and thereby parents/guardians on health education content through live educators, music, and videos. The study curriculum focuses on healthy aging vs Dementia/Alzheimer's Disease (AD), nutrition, and overall health. The investigator wishes to learn if children are able to absorb these health topics and share what they learn with their parents/guardians. That part of the program has been completed with students. This non-R01 portion of the study is designed to look at the long-term effect of the program, how it may have affected Spanish speaking families that were not approached during the first portion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: My Plate (Nutrition Education)School population without the Old SCHOOL Hip-Hop program, but with the My Plate program. |
| Intervention | Experimental | Behavioral: Old SCHOOL Hip-Hop (Dementia Education)School population with the Old SCHOOL Hip-Hop program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parent that participated in the OSHH Trial
- Parent that expressed interest in participating, but originally excluded from OSHH Trial due to language barrier
Key exclusion criteria (1 listed)
- Did not have a participating child in OSHH Trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Old SCHOOL Hip-Hop (Dementia Education)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. | Behavioural | Intervention |
| My Plate (Nutrition Education)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. | Behavioural | Control |
Primary outcome
Delayed Dementia Symptom and Response Knowledge Assessment Score
Time frame: From 15 to 48 months post baseline data collection
An instrument with multiple choice questions to assess knowledge of recognition of key signs/symptoms and ability to formulate the correct action plan in response to recognizing dementia. Parents were asked knowledge questions at three timepoints in main trial. This additional fourth time point would capture any changes in delayed knowledge retention (starting at 15-Months post baseline data collection).
Spanish Dementia Symptom and Response Knowledge Assessment Score (Spanish Speaking Parents)
Time frame: From 2.5 to 6 years post student baseline collection
Spanish Translated instrument with multiple choice questions to assess knowledge of recognition of key signs/symptoms and ability to formulate the correct action plan in response to recognizing dementia.
3 secondary outcomes
Spanish Parent Semi-Structured Interview
Time frame: From 2.5 to 6 years post student baseline collection
Adapted Dementia Attitude Scale for Children & Parents
Time frame: From 15 to 48 months post baseline data collection
Spanish Adapted Dementia Attitude Scale for Children & Parents (Spanish Speaking Parents)
Time frame: From 2.5 to 6 years post student baseline collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James M Noble, MD principal investigator
Associate Professor, Taub Institute, Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Old SCHOOL Hip-Hop (Dementia Education) and My Plate (Nutrition Education) in people with Alzheimer Disease and Dementia, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed Dementia Symptom and Response Knowledge Assessment Score (time frame: From 15 to 48 months post baseline data collection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.