Discuss any ethical issues, including those related to inequality, that might arise, as well as issues that could affect the study and how they will be mitigated.

Please submit an electronic copy of your work to Moodle. Your written coursework consists of a 2500 word trial protocol to describe how you developed a behaviour change intervention and how it will be evaluated. Q&A What is a trial protocol? A document that describes the objectives, design, methodology, statistical considerations, and organisation of a clinical trial Why are trial protocols important? “A well-written protocol facilitates an appropriate assessment of scientific, ethical, and safety issues before a trial begins; consistency and rigor of trial conduct; and full appraisal of the conduct and results after trial completion” (Chan et al, 2013, p200). Producing a protocol means that the researchers will state upfront what analysis they will undertake. This avoids a situation of data ‘fishing’ whereby if no significant changes in primary outcomes are seen following an intervention, researchers sometimes look at the data to see what other measures they have, and play around until they find something significant! What is the rationale for using a trial protocol for this piece of coursework? Producing a trial protocol will allow you to demonstrate how you have made decisions about developing your intervention and your proposed trial. A trial protocol is a highly structured piece of work, and something that you may be required to produce in the future if you work in an applied area of psychology. How will this coursework be marked? We will use the specific trial protocol assessment criteria to mark your protocol. You can find this information on Moodle. What sections are needed in the protocol? Some aspects of the protocol will be based on the SPIRIT statement. SPIRIT stands for Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT statement was produced to standardise and unify how protocol trials were reported. I have developed a shortened version of this to guide your work for this module and so there will be specific headings for you to follow (see page 2). 1 Please include the following sections in your trial protocol. Please include the word count on the front page. Title (not included in word count) This should be informative about the topic and content of the planned intervention. Background: around 1000 words, to include why this behaviour is an issue, relevant literature, examples of other interventions in this area and what works/doesn’t work, why your intervention is needed/new (see Week 1 content). Methods: around 1000 words with the following sub-headings: Participants: Who exactly will you target? (Brief section 2-3 sentences with references – Weeks 1&2). Intervention: (longest section in the method): How was the intervention developed? In this section you need to summarise all the steps in the Behaviour Change Wheel (BCW – see Week 2), using tables if you want to, describe how the intervention was developed. Be very clear to summarise the Capability – Opportunity- Motivation – Behaviour (COM-B – see week 3) model analysis in particular and how the Behaviour Change Techniques (BCTs – see week 5) link to the outcomes of the COM-B analysis. Also be very careful to tell the reader how each BCT will be delivered and think about why that mode of delivery is appropriate (see weeks 6&7). Refer the reader to your workbook in the appendix where necessary to save space, but key details must be summarised in the main text. Design and Outcomes: What kind of Randomised Controlled Trial (RCT – see week 8) will be used (simple two group design is a good idea), what the control group will experience? What measures that you will use to tell you if the intervention is successful? Will these be validated measures, or will new measures be used? Any objective measures or will this be self-report? This can also be brief. Ethical issues: Discuss any ethical issues, including those related to inequality, that might arise, as well as issues that could affect the study and how they will be mitigated (Week 4). Discussion (around 500 words) A critical reflection – (see weeks 9-10 and your reading) on the possible limitations and implications as you won’t actually conduct the trial. This should start with a very brief summary of the study and potential applications/benefits if your trial is successful. 2 The main part of the discussion should talk about some potential limitations that are possible in both the development and the evaluation of this intervention. Think about any unintended consequences and the potential to reinforce rather than reduce health inequalities. What are the practical/policy implications of your work? What else would we need to know or do to ensure that this behaviour change is maintained or could be applied to a wider group of people? Use literature in this section – reference your claims and ideas. References In APA format Appendices: Include your workbook to show how you developed the intervention. Refer to this in appropriate places in the text. Make sure your name is not on the workbook so your work can be marked anonymously. You can include intervention materials if appropriate to your topic and planned intervention. Presentation: Please use 1.5 line spacing and page numbers. Note: Tables will not be counted in the word limit and can be used to illustrate the intervention development process in the method.