Title: The TRECA study: TRials Engagement in Children and Adolescents
Funder: Department of Health and Social Care

Abstract: The aim of the TRECA study is to develop and evaluate multimedia interventions (MMI) to improve the quality of decision making about recruitment to clinical trials involving children and young people (CYP) with long-term conditions. The background to this work has several elements, including: • recurrent criticism of the length and quality of written participant information about trials, leading to participation of CYP without truly informed decision making; • possible negative effects of such decisions on trial retention and adherence to trial procedures (reducing fidelity and statistical power); and • the relative lack of robust trial evidence for healthcare interventions given to CYP. MMIs show promise for increasing knowledge and engagement with information; they may also encourage CYP and parents discussing and sharing decisions within the family. The ready availability and use of smartphones and tablet computers, particularly among young people, may be reflected in preferences for information to be conveyed in electronic (not paper) form. The study will comprise two empirical phases: development and testing (10 months); then, evaluation (15 months). Development: We will first create two template MMIs for use on desktop and tablet computers and smartphones. One MMI will be intended for parents and young people making a consent decision; the second will be a simpler MMI for use by children at an earlier developmental stage, when being asked to give assent. The MMIs will include infographics, short embedded video clips (featuring clinicians and previous trial participants) and some written text. Content will mostly be generic (i.e. the same for all CYP trials around common issues such as randomisation and consent), with a smaller amount specifically related to the host trial. To develop the MMIs we will conduct qualitative research with CYP, parents and clinicians (separately), to ascertain preferences for content, style and delivery. In a second round of qualitative research, participants will discuss the draft MMIs, which then will be revised accordingly. The qualitative data from both rounds will be analysed using Thematic Analysis. To refine the MMIs we will then conduct User Testing (with 40 CYP and parents in each round), to test the ability of the MMIs to help participants to find and understand important information. Changes to the MMIs will be made between rounds, as required. We anticipate 2 rounds of user testing. Evaluation: The MMIs will be evaluated in a series of trials nested within host healthcare trials involving CYP. Potential host trial participants will be allocated randomly to receive either standard written participant information or standard written information plus the MMI(s). When the patient is a young child, both MMIs may be used - for the parent and the child. The outcomes are cognitive (i.e. the quality of decision making; satisfaction with consent process) and behavioural (rates of recruitment to, and retention in the host trials). We anticipate conducting and meta-analysing 6 nested trials, seeking to maximise generalizability by varying the host long-term condition, the clinical intervention and, where possible, the ages of the target CYP. Months 26-28 will involve writing the final project report and dissemination.

Lay abstract: The aim of the TRECA study is to improve the engagement of children and young people with long-term conditions in clinical trials. Patients are usually informed about a trial via printed information sheets, which have been much criticised for being too long and technical to inform patients adequately. Multimedia interventions - that is a computer-based information resource including some text, some audio, some video and animations - offer the potential for better informing patients (and their parents). Some existing research with adult patients suggests that they may work well to inform people about medical procedures and research participation. There is no current research in younger patients. In this study patients would be provided with an information resource – viewed on a computer – which will include details both of the trial that the patient is being asked to consider, and trials in general. The resource includes content that the user reads, as well as some short video clips (featuring ‘talking heads’) that the user can watch and listen to. The user can choose which sections to read and view, and in which order. It may be possible for the user to post questions on the MMI, so making it interactive. We will develop 2 MMIs, one for parents and young people being asked for consent, and another (less complex) for younger children at an earlier development stage (being informed about a trial or being asked for assent). The two MMIs will mostly feature content that would apply to all trials and a lesser amount that will apply to the specific trial that the patient is being asked to consider. We have experience of developing a similar MMI for use in trials with adults, and will draw on that experience for this work involving children and young people. The study will have 2 phases. First we will develop and test the MMIs. Second we will evaluate the effects of the MMIs in 6 different healthcare trials involving children and young people. In the development and testing phase we will conduct group discussions with children and young people, parents and clinical staff, to identify preferences for content, tone, style, delivery, etc. We will then develop the MMIs before returning to the groups for more discussion. Then revise the MMIs as required. The MMIs will then be tested for people’s ability to find and understand content. We will do this by conducting individual interviews with children, young people and parents. After a round of 20 people on each MMI, we will revise them as necessary. Then test them again, then revise as needed. In the evaluation phase we will use the MMIs in 6 host healthcare trials, with potential host trial participants seeing either the standard written trial information or the standard written information plus the MMIs. They will see the MMI(s) when being asked to take part in the host trial. We will assess participants’ decisions – that is, how sure they are that they have made the right decision and how satisfied they were with the process – and also look at rates of recruitment to the healthcare trials and how long people stay on them. We will combine the results of the 6 trials statistically. Children and young people (and parents) will be involved throughout as a study PPI group: piloting materials, helping to run discussion groups and jointly presenting study results. We will report the results in journals, at conferences and in presentations to specialist centres that run children’s trials.

Research activity codes: 5.6 PSYCHOLOGICAL AND BEHAVIOURAL;7.3 MANAGEMENT AND DECISION MAKING
Health categories: GENERIC HEALTH RELEVANCE