TRECA (Phase 1 - Qualitative study) Version 1
Research type
Research Study
Full title
The TRECA study: TRials Engagement in Children and Adolescents
IRAS ID
195396
Contact name
Peter Knapp
Contact email
Duration of Study in the UK
2 years, 1 months, 30 days
Research summary
Randomised control trials are the best way to determine the effectiveness and safety of healthcare interventions. However, very trials involve children and adolescents. Thus, important clinical decisions are made based on extrapolating evidence from trials involving adults. High rates of patient/parent refusal to participate are a barrier to successful trials, though this could be reduced by improving the quality of information provided about trial participation. Current participant information sheets are widely criticised for being too long, technical and lacking in visual appeal. Multimedia interventions (MMIs) involving text, audio, video and animations have potential to better inform children, adolescents, and parents, which could lead to increased engagement with trials.
The TRECA study has two parts (Phases 1 and 2). This research ethics application is limited to Phase 1, study 1 (see protocol pp7-10), but the wider study is detailed in the protocol. In study 1 two MMIs will be developed (one for parents and older children, and one for younger children), for use in clinical trials. Both MMIs will have generic trial information (e.g. on randomisation and study withdrawal) and a template for trial-specific information (e.g. trial purpose and length). The development of the MMIs will be influenced by the views of relevant stakeholders (e.g. young patients with long-term conditions, parents, clinicians), which will be collected during two rounds of focus groups. The first round of focus groups will take place before the MMIs have been designed to inform their content, style and delivery; the second will take place after the design of draft MMIs, to collect participants’ views and any ideas for amendment.
We will apply for research ethics approval to conduct Study 2 of Phase 1 (user testing) and Phase 2 (evaluation of the MMIs in actual trials) in applications later in 2016.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0158
Date of REC Opinion
13 Apr 2016
REC opinion
Favourable Opinion