Old SCHOOL Hip-Hop: A Randomized Controlled Trial to Improve Alzheimer's Disease Knowledge
Phase: NA
Conditions: Dementia
Sponsor: Columbia University

 
 
 
 
 
 
 
 
 
 
 
 
 
Old SCHOOL Hip-Hop: Improve Alzheimer's Disease Knowledge 
 
NCT03284112 
Last Approved Date: April 16, 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

RESEARCH METHODS 
6.1. Phase 1: Program Refinement. The first 6 months of the project period will focus on generating a larger 
item pool using focus groups and cognitive interviews.  These items will be administered during the study in 
order to provide data for future/further development of outcome measures for AD recognition.  Additionally, items 
to measure self-efficacy and other constructs relevant to the study goals will be added and examined in relation 
to the outcome; these will comprise a novel “dementia action test” (See Section 6.5.1.). Concomitantly, a 3- 
minute program cartoon will be developed, mapped to our song, comics, and character icons focusing on the 
FLOW mnemonic and primary behavioral outcomes; these products were created in advance of this application. 
6.2. Phase 2: OSHH Randomized Controlled Trial 
6.2.1. Study Design. We will use a cluster randomized controlled trial (RCT) design with random assignment of 
10 schools to each of two arms: control 
and intervention (Figure 4). The data 
coordinating 
center 
has 
developed 
randomization 
algorithms 
for 
rolling 
enrollment as schools will be contacted on 
a rolling basis over the 5 year study period. 
Outcome measures are (1) Child’s recall of 
dementia symptoms (at 3 days and 3 
months follow-up), (2) parent’s report of 
whether the child communicated the 
information (at 1-week follow-up) and (3) 
parent’s recall of the symptoms and 
response (at 1-wk and 3-m follow-up). 
6.2.2. Population. 4th and 5th grade 
children (ages 9-11y), and their parents 
(age > 20 years), in selected NYC public 
schools with similar sociodemographic 
composition. Exclusion criteria. Schools 
having already received pilot OSHH and HHS programming.  
6.2.3. Recruitment and Retention. School Principals identified by School District Superintendents, Department 
of Education Health Directors, and local relationships, will be contacted by phone. A meeting will be scheduled 
with research staff and the school principal to show a specially- developed 10-minute explanatory video that 
shows the OSHH curriculum and program objectives; and questions about the program will be answered. Once 
the principal has agreed for his/her school to participate, research staff will work with parent coordinators to 
identify 4th and 5th grade students and their parents from school rosters. Parents will be recruited in-person at 
school events and/or by telephone. Informed consent from parents will be obtained for the enrollment of their 
child and themselves in the study. Assent will be obtained from each participating child. Based on our pilot study 
we estimate that 35% of parents will refuse to participate. Parents and students are informed that testing will 
have no impact on grades or school relations.  
6.2.4. Alternative recruitment strategy. In clinical trials, recruitment often becomes a problem because if the 
researchers have overestimated their ability to recruit at a particular site, they must have a plan to open up 
additional sites. That is not a relevant concern here. Once the school has agreed to serve as a site, we will 
include all the children in the 4th and 5th grades. If, for any reason, one or more children choose (or their parents 
choose) not to participate, or if the child missed school on any or all of the days on which the program was being 
implemented, this would not indicate a need to recruit “replacements”, nor would it affect our statistical power, 
which is calculated using the school, not the child, as the unit of analysis. 
Figure 4. Enrollment Flow Diagram 
Delayed post-test 
Children & Parents at 
3 months  
Intervention arm 
(OSHH) 
N=10 schools 
Children baseline 
knowledge 
assessed 
1-hour sessions 
conducted on 3 
consecutive days 
Control Arm 
N=10 schools 
Children baseline 
knowledge 
assessed 
Enrolled parents and 
given baseline dementia 
knowledge assessment  
Parents contacted, 
informed consent given 
Children (Grades 4-6) 
identified from rosters 
Schools identified, 
recruited 
Schools randomly 
assigned to condition 
1 month 
Children: Immediate 
post-test on Day 3 of 
programs 
Parents: 1-week post-
intervention test  
1 month 

6.3.1. Old SCHOOL Hip Hop Intervention. Hip-hop is a music genre that strongly emphasizes rhyme and 
dance, and is popular among diverse socioeconomic and ethnic groups.46  Integrated rhyme and dance have 
been successful educational tools in non-health oriented education programs.47-49 Hip-hop has specifically been 
used as a vehicle for obesity prevention in African-American preschoolers50 as well as in our stroke education 
model. 1, 3, 4 Guided by an interdisciplinary team which included school principals, school-aged children with 
whom focus groups and semi-structured interviews were conducted, public health experts, children’s education 
television/media experts (formerly of Sesame Street), hip hop artists, bio-behavioral researchers and clinical 
dementia experts, we developed our OSHH program using community engagement techniques.  
In the course of project development, we were particularly mindful of the potential for introducing undue 
distress on these children by burdening them with the responsibility of being arbiters of family dementia 
knowledge. We specifically reviewed these concerns with the focus group and engaged a child psychologist, 
both of whom identified stroke as likely more burdensome given its immediate, urgent, and physically apparent 
presentations. However, due to the Entertainment Education framework of our intervention, which includes the 
use of the hero concept (making stroke communication to parents a potentially life-saving heroic act),we had no 
such adverse outcomes in the 5 year experience with our related Hip Hop Stroke (HHS)  program (Section 5.1).  
The final intervention is a 
modular 1 hour/day for 3 days 
school-based multi-media dementia 
educational program designed to 
increase dementia literacy among 
4th and 5th grade children, and to 
motivate 
them 
to 
deliver 
the 
message to their families and adult 
caregivers with the aid of homework 
activities 
OSHH 
uses 
dance, 
culturally 
and 
age-appropriate 
music, role-play skits, and short 
animated films as motivating tools to 
enhance a simple didactic program 
delivered over three days (See 
Table 1). Students are educated 
using interactive play, cartoons, and 
an original song featuring an AD-
themed rap. For the development of 
a mnemonic novel to this program, 
we reviewed validated concepts of 
AD 
relevant 
to 
public 
health 
awareness including the Alzheimer 
Disease Knowledge Scale, 42 the 
Alzheimer’s Association’s “Know the 10 Signs,” 51 as well as extensive clinical experience of the investigators. 
Through our experience with the HHS program, we found that six to seven key disease knowledge elements 
could be reasonably included in a combination of mnemonic and simple related messaging and retained for a 
Table 1. Old SCHOOL Hip Hop Daily Curriculum 
Topic 
Day 1: 60 minutes 
Day 2: 60 minutes 
Day 3:  60 minutes 
• Pre-test  and  
• Introduction to dementia  
• Review Day 1 
• Home/family activities reviewed 
• Review Days 1&2  
• Post-test evaluation 
Content 
1. Demo of electronic keypads 
2. Unprompted pre-test 
2. Content:  
a. Normal v. pathological cognitive aging.  
b. Concepts of long term storage and neural 
networks  
c. “Go with the FLOW” animated feature (See 
Section 6.5.1.b)  
e. Children are encouraged to discuss 
learning’s w/parents 
Content:  
a. Early detection/early 
identification/early treatment  
b. Safety/Wandering 
c. Instructions to log onto website 
with parents to view cartoon and 
also given DVD of cartoon. 
d. Children encouraged to engage 
parents with comic book activities.  
1. Review days 1&2; Hip 
Hop To-Go activities. 
2. Repeat all animated 
features and songs. 
3. Encourage child to 
engage parents in home 
activities  
4. Early Post Test  
 
 
Figure 5. OSHH comic book excerpt distributed at the program, reviewing the 
“FLOW” mnemonic and examples of normal versus pathologic cognitive aging 

prolonged period of time.1, 3 As such, our group devised the “F.L.O.W.” mnemonic (Forget, Lose, Overlook, 
Write/Wander), which captures many of the cardinal symptoms of AD, including Forgetting conversations, words, 
people/names, or dates, Losing objects, one’s way (direction), or interest, Overlooking bills, hygiene, household 
cleanliness, or safety, and increasing reliance upon Written lists or Wandering away from the family. In addition, 
we include key AD educational elements of localization (that AD occurs in the brain, areas specific to memory, 
and the hippocampus). We also review additional AD symptoms of executive dysfunction through role play.  
In response to recognizing a patient with possible AD, we teach students to “Go With The FLOW” – a call 
to action that includes bringing AD symptoms to the attention of unaffected adults in the family unit, encouraging 
medical evaluation, and using methods to improve the household safety of a person with AD. With each AD 
symptom, we provide comparisons with normal aging, intending to improve the sensitivity of AD symptom 
recognition (and lowering the false negative fraction of symptom recognition), while also focusing on deceasing 
the false positive symptom identification (and thus increasing specificity); we emphasize that in normal cognitive 
aging, symptoms occur “once in a while,” whereas AD symptoms are more consistently present, occurring “all 
the time.” The FLOW mnemonic reinforces key symptoms. Two contrasting adult characters: “Ima Good” (normal 
cognitive aging) and “Anita Help” (concerning for AD) are introduced to emphasize these points (Figure 5). After 
reviewing each profile, students are asked to decide if the characters are experiencing normal aging or if one 
“might have the FLOW” (AD). The intervention also involves behavioral engagement, with role-play of AD 
symptoms and communication of the AD-related information to an adult. AD concepts are introduced in a comic 
book (Figure 5; See Supplemental File: Comic) which is distributed during the program and made available on 
our website along with the program’s song “Go With The FLOW.” Grouped by grade, the students will be 
educated within school auditoriums. The educational team will be comprised of two facilitators developed and 
monitored as described in Section 6.4.b. Each child will be given a hand-held audience response system and an 
ID card with a unique 4-digit identifier – a data collection method we have used successfully in our prior studies.52 
Children will be instructed to enter the ID number during each test (See Section 6.4.b.).  
3-month booster session: After 3 months, an unprompted posttest will be administered to assess retained 
knowledge from the program. This post-test will be followed by a brief OSHH booster session. Table 1 reviews 
the curriculum for that date as well.   
6.3.2. Attentional control condition: My Pyramid in Egypt.  The program selected for the control arm, “My 
Pyramid in Egypt,” 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. The New York State “Healthy Schools Act” of 2007 requires 
school districts to establish “School Wellness Policies” that include a nutrition education curriculum and physical 
activity. Trained facilitators will conduct “My Pyramid in Egypt” using Egyptian history as an entry point for the 
USDA’s MyPyramid nutrition program. Students will learn about MyPyramid and MyPlate across the 3-day one-
hour-a-day program. The educators will be shown an edited music video for Michael Jackson’s Egyptian-themed 
video “Remember the Time.” Similar to the intervention, control children will be provided with a take-home activity 
sheet on Day 1 to complete. Parallel pre and post-tests will be conducted with the control children, using the 
same test sequence as the intervention. Three months later, students will be assembled by program facilitators 
for an unprompted, post-test and booster “My Pyramid in Egypt” session to mirror intervention procedures. 
6.4.a. Data tracking. An innovative aspect to the conduct of the trial is our use of an audience response system 
that allows us to track individual children’s’ test scores throughout the trial period.52 The system uses a hand-
held electronic wireless keypad which engages and excites children all of whom have grown up in the digital 
age. Each child is assigned a unique ID, entered via the keypad; and the children use the keypad to enter 
information, including their answers to probe questions (to assess learning and retention). The questions 
themselves are presented to the group by projecting them onto a large screen. This system allows us to easily 
keep track of real-time test results that are stored for subsequent analysis, for a large volume of participants, 
without the expense and transcription errors of manual data entry.  
6.4.b. Program Fidelity. Program content will be standardized through a digitized, standardized curriculum 
(digital slide-show) and educator performance will be measured against a program standard (See Supplemental 
File: Evaluator Assessment Form). Our training program was designed for Lay Health Educators to facilitate 
scalability. Our Lay Health Educators having already delivered our pilot studies will be prioritized to deliver this 
program; their performance during the pilot program was filmed and establishes the program standard. Each 
additional/new Lay Health Educator will watch that performance, learn the new curriculum, and co-teach the 
program with one of our senior educators prior to independent facilitation. Any new educator must meet set 
standards for independent work prior to initiation. Research staff will thereafter perform biannual fidelity activities 
on program delivery to ensure compliance with OSHH protocols and procedures. Qualitative assessments of 

performance will be done through videotaped performances that will be reviewed by research staff in conjunction 
with the educators. Educators will complete a self-assessment (See Supplemental File: Self-Assessment Form) 
in advance of being provided feedback on specific and remediable aspects of performance to meet consistent 
standards. Educators not meeting expected standards will be provided remediation and tracked at their 
subsequent performance. Two successive performances below expectations will require the educator to be 
formally retrained and will not be able to teach independently until meeting expectations. Quantitative 
assessments of educator and program performance will measured in real-time using outcomes tracked by the 
audience response system and linked with the qualitative observations. We will also track the use of our online 
program portal by participants and benchmark this access so that we can monitor it for outliers.  
6.5. Procedures 
6.5.1.a. Item pool generation. Focus groups and cognitive interviews will refine item generation of the planned 
“dementia action test” relating key FLOW items with hypothetical scenarios and expressed behavioral 
intent.  Included will be measures demonstrating self-efficacy and attitudes, including relevant elements of the 
Dementia Attitudes Scale53  
6.5.1.b. “Go With the FLOW” Cartoon development.  A 3-minute program cartoon similar in style to our Hip 
Hop Stroke cartoons1 will be developed and mapped to our existent song of the same title (See Supplemental 
File: Lyrics), related comics, and character icons (see Figure 5) focusing on the FLOW mnemonic and primary 
behavioral outcomes. 
6.5.1.c. School selection/recruitment. The Office of School Wellness of the New York City Department of 
Education and local school district Superintendents will collaborate with Investigators to identify NYC schools 
with similar demographics, excluding schools having already participated in our programs. School Principals will 
be invited to participate in the research study during face-to-face presentations of the intervention and control 
programs. During this meeting, a specially developed 10-minute explanatory promotional video will explain the 
OSHH intervention and show the curriculum and program objectives, and questions will be answered. 
6.5.2. Selection/recruitment of children. Children in 4th and 5th grades in participating schools will be identified 
from school rosters along with their parents, who will be contacted via telephone or in-person at school events 
by research team for the purposes of informed consent (occurs three months prior to the start of data collection). 
6.5.3. Selection/recruitment of parent. To maintain statistical independence, only one adult from each family 
will be interviewed. Rather than arbitrarily targeting whichever parent happens to answer the phone or is met in-
person, we will ask the parent to identify the adult (“parent”) in the household (“household” may include relatives) 
who is most likely to have been the target of the child’s dementia-information communications. 
6.5.4. Baseline knowledge assessment in parents. Parents who have given consent will be contacted in-
person at school events or by telephone one month later, and a baseline dementia knowledge questionnaire will 
be administered following a brief health literacy survey (see Section 6.6-6.7 for details). We will assess parental 
knowledge of key signs and symptoms of dementia and the correct course of action through questions identical 
to those used for the pre-testing of their children. 
6.5.5. Randomization to arm. The data coordinating center has developed randomization algorithms to 
incorporate rolling enrollment which will be applied as schools will be contacted on a rolling basis over the 5 year 
study period. The investigators will not be told which arm any given school is assigned until after the baseline 
assessments have been completed. It is not possible to blind to condition, once intervention has been assigned. 
6.5.6. Baseline knowledge assessment in children. Around one month after the baseline knowledge 
assessment in parents, all participating children in both arms of the trial will attend a session to be held in the 
school auditorium, during which children’s’ knowledge concerning dementia symptoms and response will be 
assessed (see Sections 6.6-6.7 for details). 
6.5.7. Implementation of the intervention/control. The intervention and control conditions will be implemented 
immediately following the children’s’ pretest knowledge assessment. Certified lay health facilitators will conduct 
the intervention or usual care program in 1-hour sessions, over three consecutive days, in schools assigned to 
the either the intervention or control arm. An immediate post-test will be administered at the end of the third day 
to children in both the intervention and control arms. 
6.5.8. 1-week follow-up data collection (parents). One week after the completion of the 3-day intervention and 
control programs, follow-up surveys will be conducted in-person at school or, when that is not possible, by 
telephone (with a telephone protocol of up to five telephone contact attempts if necessary). These surveys 
assess: (1) Has the child told parent about participating in OSHH at school and discussed dementia with them? 
and (2) Does the parent recall what the child communicated regarding the symptoms and recommended action? 
To assess these, the research surveyor will use a structured interview format (See Sections 6.6-6.7). 

6.5.9.a. 3-month follow-up data collection (children). Three months following the 3-day intervention and 
control programs, students will be assembled once more in school auditoriums by program facilitators for a 
delayed post-test after which the educational booster sessions will be provided to students. Children in both 
conditions will participate in 30-minute review sessions; children in the intervention arm will see the OSHH 
material; those in the control arm will review the “usual care” material. 
6.5.9.b. 3-month follow-up data collection (parents). Three months following the completion of the 
intervention and control programs, a second survey will be conducted (in-person or, when that is not possible, 
by telephone) on parents to assess long-term retention of the materials. 
6.6. Outcome Measures 
6.6.1. Dementia Symptom and Response Knowledge Assessment (student). We will use similar instruments 
to those in our OSHH pilot study27 to replicate our findings by assessing children’s pre- and post-test knowledge 
of AD symptoms and recommended action. Multiple choice questions will be given to assess knowledge of (1) 
dementia localization (Where in the body does Alzheimer disease occur?(brain) In which part of the brain does 
Alzheimer disease happen? (Remembering part) What part of the brain helps you remember? (Hippocampus) 
(2) Recognition of 6 key signs/symptoms (Forgetting words and familiar faces and names; Losing things all the 
time; Overlooking chores like paying the bills and cleaning; Writing things down all the time; Having trouble 
counting out the right amount of money when paying; Having trouble using household appliances like a remote 
control or microwave) plus two distractors (Chest pains, Facial droop), (3) Response to symptoms presented in 
a hypothetical scenarios in which the dementia diagnosis is not given (considered normal aging v. concerning 
for dementia (and needs to be seen by physician), (4) assessment of the FLOW mnemonic, (5) self-efficacy for 
dementia recognition, and (6) ability to formulate the correct action plan in response to recognizing dementia 
6.6.2. Assessment of child’s communication to parent about dementia signs/symptoms. This measure 
assesses whether the child has talked with one of the adults in the household – in both the OSHH and control 
arms – concerning symptoms of dementia and correct response. 
6.7. Baseline measures 
6.7.1. Demographic Form. Includes age, sex, and race of children and parents; also educational status, income, 
sex, and age of parents and caregivers; and number of adults in household. Measures of school-level economic 
need are available in the public domain via the NYC Department of Education. 
6.7.2. Literacy Questionnaire We will assess health literacy of parents prior to baseline assessment of 
dementia symptoms knowledge. We will use a rapid bilingual (English and Spanish) screening tool that identifies 
patients at risk for low health literacy, called the “Newest Vital Sign”, and has been validated by clinical studies.54 
6.8. Power Calculations and Analyses  
Power calculations were performed for the primary aim of evaluating the effect of the intervention on the 
parent-level recognition of AD symptoms post-test and at three months post intervention. The outcome was 
treated as both continuous and binary for the most conservative test of meaningful change. 
6.8.1. Design Features:  The design is a cluster randomized trial with random assignment of 10 schools to 
each of two arms.  Subjects will be nested within schools and classrooms.  We posit a relatively lower intra-
cluster correlation coefficient (ICC) for schools than for classrooms.  Estimates have been adjusted for 
unreliability of the outcome (estimated at R=0.70) and clustering.  The variance inflation factor (Vif) =1.87, 
assuming that ne (the average number of subjects within a class) =20; the intracluster correlation coefficient for 
class (ICCclass ) =0.03 and for school (ICCschool)=0.015; Ns (5th and 6th grade classes) =2.  The pooled σ 
(standard deviation) is estimated at 1.06, based on our prior work. Assuming a two-tailed test with α=0.05, 
power (1-β=80%), n=400 parents per group will be adequate to detect posited effect sizes shown below.   

6.8.2.Power and Analyses for 3 Level Cluster Sampling and Evaluation of Pre- and Post-Intervention, 
Treating AD Symptom Recognition as Continuous:  Power calculations were from the perspective of least 
detectable group differences in rates of change (slopes), adjusted for the design effects of correlations induced 
by repeated measures of subjects nested within classrooms and schools.  Different scenarios regarding 
correlations among the repeated outcomes were considered.  The mixed model for rate of change in outcome: 
lm
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, (equation 1) where ijk refers to subjects, time points and group;  FUlm is the random 
effect associated with school and class; T=0 is the pre-test and immediate post-test and T=1 is the 3 month 
post-test. The sample size formula for the rate of change55 is:
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within class, ns is the number of classes within schools, rho e is the ICC for classes, rho s is the ICC for 
school.57  For different values of ρrm (the average correlation of the repeated outcome measures, we provide 
detectable rates of change and accompanying Cohen’s d effect sizes. For ρrm=0.4, the detectable rate of 
change (β1=0.29) over 3 months from the model in equation (1) translates to a Cohen’s d (endpoint difference 
between the intervention and control group/pooled standard deviation) of 0.27 or for ρrm=0.6, β1=0.27 and 
Cohen’s d=0.25.  Given the above scenarios, we will be able to detect relatively small effect sizes in terms of 
endpoint differences between the intervention and control groups.  The Ancova model using a pretest score as 
covariate will improve power.  The formula is
lm
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intervention group improves by δ (Cohen’s d=δ/σ) over the control group at the 3 month post-test, we can use 
different weights for the immediate post-test in calculating power (a1=0 indicates no increased test 
performance for the intervention as contrasted with the control group at immediate post-test, a1=1/2 indicates 
50% increased performance of the intervention over the control group, and a1=1 indicates 100% increased 
performance of the intervention as contrasted with the control group).  The sample size formula for the Ancova 
model58 is: 
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2, smaller effect sizes are detectable under the scenario that there is some improvement immediately as well 
as at 3 months. 
6.8.3. Power for 3 Level Cluster Sampling and Evaluation of Pre- and Post-Intervention, Treating AD 
Symptom Recognition as binary:  A generalized linear model with a canonical (logit) link will be modeled using 
GLIMMIX. Subgroup analyses will be conducted by inclusion of interaction terms for moderator variables.  
Using the canonical link (Logit), the generalized linear mixed model (GLIMMIX): 
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the random effect associated with school and class, tj=0 is the pre-test and immediate post-test and tj=1 is the 
3 month post-test, with variance inflation factor (Vif). The sample size formula for intervention-control 
comparison of repeated binary measurements59 is: 
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and variance inflation factor (Vif) as specified above. The proportion passing (operationalized as getting 80% of 
items correct), assuming that the two groups are equivalent at the pre-test, and that there is no change in the 
Table 2.  Power Analyses for Ancova. 
Correlation 
a1=0 
a1=1/2 
a1=1 
ρ=0.4 
δ=0.315  (d=0.300) 
δ=0.210  (d=0.200) 
δ=0.158  (d=0.149) 
ρ=0.5 
δ=0.298  (d=0.281) 
δ=0.199  (d=0.188) 
δ=0.149  (d=0.141) 
ρ=0.6 
δ=0.275  (d=0.259) 
δ=0.184  (d=0.174) 
δ=0.138  (d=0.130) 
ρ=0.7 
δ=0.246  (d=0.232) 
δ=0.164  (d=0.154) 
δ=0.123  (d=0.116) 
The difference between intervention and control at 3 month post-test: (δ is the point difference in AD 
symptom recognition and d is Cohen’s d) 

control group at immediate post-test. The table below assumes fixed adjusted differences of16.7%.  (The 3 
month post-test difference adjusted by the immediate post-test (P22-P21-(P12-P11)=16.7%.) This restriction 
permits comparison of the power across different models. The models show either 5% improvement in rates of 
passing at 3 month post-test in the control group and or 5% or no improvement at the immediate post-test in 
the intervention group. Table 3 shows that for different pre-test passing rates (from 30% to 50%), the posited 
adjusted difference of 16.7% can be detected with > 80% power when the correlation between repeated  
measure ρ=0.4 (which is conservative considering that the 3 repeated measures are within 3 months, and that 
increasing ρ will increase power). It also shows that as the average passing rate at 3 months approaches 50%, 
power will be the lowest in comparison with lower or higher passing rates. If we only used two waves of data 
(pretest and 3 month), the minimal detectable difference in passing rates between the intervention and control  
groups at 3 month post-test would be18%. Dropping the immediate post-test will result in a slight loss in power.  
6.8.4. Secondary Aims 
Analyses of Correlates and Predictors of AD Recognition:  Treating the outcome as continuous, 
relationships with variables such as economic need, educational attainment and other demographic variables 
will be examined using a mixed model similar to that described above for continuous outcomes. 
Measurement Analyses:  The proposed Data Coordinating Center (DCC) has considerable experience in the 
conduct of measurement analyses.  A detailed explication is beyond the scope of this proposal.  Briefly, 
qualitative methods will be used to develop an item pool for future analyses and development of an ancillary 
outcome measure.  Although extensive qualitative work informed the development of the proposed legacy 
outcome measure used to power this study; it is recognized that additional measurement work would be a 
valuable contribution of this project.  Given the large sample sizes, it would be possible to begin the 
development of additional measures of AD recognition.  Development of the measure using factor analytic and 
item response theory models is beyond the scope of this project; however, generation of the item pool will be 
an invaluable first step in this process.  The qualitative methods will include (1) convening experts and focus 
groups to generate additional items for the item pool; (2) ratings of the importance of the items and relationship 
to the construct; (3) cognitive interviews to determine the meaning of the items; (4) translation of the items.   
6.8.5. Missing Data:   Analyses will follow the intent-to-treat principle. Based on previous experience with 
similar programs, we anticipate minimal missing data. Using the above-described FIML approach to estimate 
treatment effects, assuming that missing data are either missing completely at random or at random; this 
method, with a covariate to adjust for attrition bias, yields intent-to-treat parameter estimates that are 
consistent with that expected if there were no missing data. Scales will be prorated for missing data, using 
individual imputation algorithms. If substantial missing outcome data are observed, we will use a specific 
imputation approach, e.g., Markov Chain Monte Carlo procedures60 based on the amount and pattern of 
missing data. In the event of substantial missing data, SAS Proc MI will be used in sensitivity analyses. We will 
perform joint simultaneous imputation; at least 50 multiple imputations will be generated and PROC MIAnalyze 
will be used to combine the results and estimate the log-odds, adjusted standard errors and significance. If 
substantial imbalance is observed, we will use propensity score analyses to equate the groups. 
6.8.7. Data Management:  The Research Division of the Hebrew Home at Riverdale will serve as the DCC, 
and will perform data monitoring and quality assurance checks of the data, including periodic review of data 
distributions. Statistical staff will convert data files to SPSS or SAS in order to facilitate performance of 
analyses. (See subcontract budget justification for further details). 
Table 3. Power Analyses for AD recognition  
Model 
Pre- 
Test 
Immediate  
Post-test 
3 month 
Post-test 
Adjusted 
difference 
Power 
 
P0 
P11 
P12 
P21 
P22 
P22-P21-(P12-P11) 
ρ=0.4 
ρ=0.5 
No improvement in 
control  
Immediate post test 
30% 
30% 
30% 
30% 
46.7% 
16.7% 
85.37% 
89.51% 
40% 
40% 
40% 
40% 
56.7% 
16.7% 
83.05% 
86.54% 
50% 
50% 
50% 
50% 
66.7% 
16.7% 
83.45% 
85.87% 
Improvement in 
intervention 
Immediate post test 
30% 
30% 
35% 
30% 
51.7% 
16.7% 
83.33% 
87.27% 
40% 
40% 
45% 
40% 
61.7% 
16.7% 
82.71% 
85.69% 
50% 
50% 
55% 
50% 
71.7% 
16.7% 
84.81% 
86.67% 
Improvement in 
intervention and 
control post test  
30% 
30% 
35% 
35% 
56.7% 
16.7% 
80.00% 
84.02% 
40% 
40% 
45% 
45% 
66.7% 
16.7% 
82.93% 
85.62% 
50% 
50% 
55% 
55% 
76.7% 
16.7% 
87.82% 
89.27% 
Passing rate: Pjk (y=1): j is the time point (j=0 for pre-test, j=1 for immediate post-test and j=2 for 3 month 
post-test. K=1 for control, k=2 for intervention) 

6.9 Timeline. We plan for a 6-month startup period, entering the first school in Month 7 of Y1, and thereafter in 
new schools, approximately every 1-2months during the 6-7month accessible school year (eliminating vacation 
and summative test periods; parental assessments can occur year-long). Data collection for all but follow-up 
reports of events will cease in Month 3 of Year 5, allowing a 9-month period for data analysis, preparation of 
results, and completion of recruitment measures. Throughout the timeline, schools receiving the intervention arm 
and having completed all study components will receive the active control condition, as requested by our 
partnering schools given NYC mandates to general health education initiatives. Table 4 shows the timeline. 
Table 4. School Enrollment Timeline 
Year 
Visit 
Month 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
1 
Start 
Item pool generation Start-up period; recruitment; 
cartoon creation 
(As described in 6.5.1.a-c.) 
S1 
 
 
S2 
 
 
1-wk 
S1 
 
 
S2 
 
 
3-m 
 
 
 
S1 
 
 
2 
Start 
 
S3 
S4 
 
 
S5 
S6 
 
 
S7 
S8 
 
1-wk 
 
S3 
S4 
 
 
S5 
S6 
 
 
S7 
S8 
 
3-m 
S2 
 
 
 
S3 
S4 
 
 
S5 
S6 
 
 
3 
Start 
 
S9 
S10 
 
 
S11 
S12 
 
 
S13 
S14 
 
1-wk 
 
S9 
S10 
 
 
S11 
S12 
 
 
S13 
S14 
 
3-m 
S7 
S8 
 
 
S11 
S12 
 
 
S11 
S12 
 
 
4 
Start 
 
S15 
S16 
 
 
S17 
S18 
 
 
S19 
S20 
 
1-wk 
 
S15 
S16 
 
 
S17 
S18 
 
 
S19 
S20 
 
3-m 
S13 
S14 
 
 
S15 
S16 
 
 
S17 
S18 
 
 
5 
Start 
 
 
 
Data analysis, manuscript preparation; final data collection if necessary 
1-wk 
 
 
 
3-m 
S19 
S20 
 

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