- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06699589
Old School Hip Hop: Parent Follow-Up & Spanish Speakers Inclusion
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10032
- Columbia University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parent that participated in the OSHH Trial
- Parent that expressed interest in participating, but originally excluded from OSHH Trial due to language barrier
Exclusion Criteria:
- Did not have a participating child in OSHH Trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Control
School population without the Old SCHOOL Hip-Hop program, but with the My Plate program.
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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.
|
|
Experimental: Intervention
School population with the Old SCHOOL Hip-Hop program.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delayed Dementia Symptom and Response Knowledge Assessment Score
Time Frame: From 15 to 48 months post baseline data collection
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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).
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From 15 to 48 months post baseline data collection
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Spanish Dementia Symptom and Response Knowledge Assessment Score (Spanish Speaking Parents)
Time Frame: From 2.5 to 6 years post student baseline collection
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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.
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From 2.5 to 6 years post student baseline collection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spanish Parent Semi-Structured Interview
Time Frame: From 2.5 to 6 years post student baseline collection
|
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.
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From 2.5 to 6 years post student baseline collection
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Adapted Dementia Attitude Scale for Children & Parents
Time Frame: From 15 to 48 months post baseline data collection
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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.
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From 15 to 48 months post baseline data collection
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Spanish Adapted Dementia Attitude Scale for Children & Parents (Spanish Speaking Parents)
Time Frame: From 2.5 to 6 years post student baseline collection
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A translated adapted instrument with multiple choice questions to assess parent and child dementia attitudes (comfort/stigma).
|
From 2.5 to 6 years post student baseline collection
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James M Noble, MD, Associate Professor, Taub Institute, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAR5473 - non-R01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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