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Randomized controlled trial for drug abuse prevention program in 8th-grade middle school students

Study Description

You have been asked to evaluate the effectiveness of a drug abuse prevention program (DAPP) targeted to 8th-grade middle school students. You know from your public health training that a randomized controlled trial (RCT) will be the best way to determine if the program works to prevent drug use, specifically, alcohol use in 9th grade. You determine your experimental (intervention) and control conditions:

1. Experimental. DAPP consists of attending workshops during lunchtime and completing homework assignments.


2. Control. For this study, you decide that students in the control condition will receive information about healthy eating.

1. First, you assemble your study cohort of middle school students.


2. Then you collect relevant baseline data on your entire cohort.


3. Next, you randomize your cohort into intervention (experimental) and comparison (control) groups: you randomly assign students to receive either DAPP (intervention) or nutritional information (control condition). 

 1. 1,800 8thgrade students have parental permission to participate in your study. You randomly assign the students to two equal-sized groups (DAPP or control). The outcome you are interested in is student-reported use of alcohol in the 9th Label each box and show the correct number of students to the basic RCT design diagram for your study below. You will be calculating some of the information later in this lab. (3 pts.)


2. You are concerned about adherence (students sticking with their assigned exposure). Propose twoways you could monitor your study to track whether students stayed with their assigned groups. (2 pts.)


3. To assess your outcome of alcohol use in 9thgrade, you give self-administered questionnaires to the students during their 9th grade school year. Assume that you are able to track and survey 100% of the students from your study (Note: This only happens in EPBI 3101, not in real life). You observe that 300 students who received DAPP used alcohol in 9th grade, and 530 students in your control group used alcohol.  Use these results to fill in the numbers and complete your diagram in Question

4. Construct a 2x2 table reporting your study results. (4 pts)

5. Calculate the incidence of alcohol use among students who received DAPP. Write the formula and show your work. (3 pts.)


6. Calculate the incidence of alcohol use among students in the control group. Write the formula and show your work. (3 pts.)


7. Calculate the relative risk of alcohol use in those randomized to DAPP compared to those who received the control. Write the formula and show your work.  Write one sentence explaining this result. (4 pts.)


8. Can you determine causality with this study? Please explain your answer by providing arguments about why you can determine causality. (3 pts.)

9. Check ALL the statements that are true (3 pts.) 2pt


10.Nonadherence in a randomized controlled trial makes the exposed and unexposed groups more similar, which reduces the ability of the investigator to detect a difference between the groups.


a. A randomized controlled trial is a type of analytic epidemiology study.


b. In observational studies, the investigator manipulates or assigns participants to exposed and unexposed groups.


c. It is not possible to test causality using RCTs.


d. Randomization protects against bias and confounding.


e. In single-masked study, neither the study participants nor the observers are aware of the participants’ group assignments.


f. RCT endpoints must be well-defined, reproducible, clinically relevant, achievable, and applicable.

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