Develop and describe the study design you outlined in your Specific Aims. The methodology for the study you design should contain a high degree of scientific rigor. If your study is attempting to examine a cause

Methods (2-3 pages): Use this section to describe how you plan to carry out the research. Develop and describe the study design you outlined
in your Specific Aims. The methodology for the study you design should contain a high degree of scientific rigor. If your study is attempting to
examine a cause and effect relationship, you will need to address threats to internal validity. Most threats to internal validity should be
controlled, and reasonable efforts should be made to minimize measurement bias. This proposal should provide a concise enough description
on how the study is to be conducted so that readers would be able to conduct the study themselves from your description. Remember to write
this paper in future tense, i.e. "will do".
• Sub-Headings:
• Research Design: Identify and describe the specific research design
• Setting: Describe the setting and how it will provide the sample population of interest
• Sample: Describe the sampling procedure, how the recruitment and selection process will occur, and consent process
1. 1.
1. Identify the subject pool
2. State your inclusion and exclusion criteria
3. Provide projected number of recruited subjects (n=).
• • Procedures: In this section you will describe the process of implementing your study. What, exactly, will you DO? (Be extremely
specific!)
• • • Recruitment
1. 1. 1. 1. What will your recruitment procedures look like?
2. Describe your consent process
• • • Intervention: Describe the intervention or program being studied. Describe the control or comparison condition that will be
used. What will or do subjects in this condition receive?
• Measurement
• Identify your dependent variable(s)
• name of the variable
• describe how you are operationally defining it/them
• identify specifically how it is measured (question, scale, standardized measure, etc.)
• identify the level of measurement (dichotomous, categorical, continuous)
• Identify your independent variable(s)
• name of the variable
• describe how you are operationally defining it/them
• identify specifically how it is measured (question, scale, standardized measure, etc.)
• describe level of measurement (dichotomous, categorical, continuous)
• • Analyses: Describe the analytic procedure that you will use for your primary outcomes and any secondary outcomes.
• Limitations
1. 1. 1.
1. Discuss the potential limitations of the study (sampling, ethical, political issues)
2. You MUST discuss issues of internal and external validity.