SMILE – Specialist Medical Intervention and Lightning Evaluation
What is SMILE?
SMILE is a randomised controlled trial for children and young people with CFS/ME. The trial recruited children and young people (aged 12 to 18 years old) from a specialist paediatric CFS/ME service in the south west of England. Participants were randomised to receive either specialist medical care (SMC) or SMC plus the Lightning Process (LP).
SMILE started as a feasibility study as we were not sure whether it would be possible to recruit children and young people in to this study. We have published our report on the feasibility phase and you can find it here (PDF, 458kB)
The feasibility phase helped us design the full trial and we have published our protocol which you can look at here (PDF, 565kB)
We have now finished recruiting and we plan to break the code and conduct the analyses in May/June 2014. We hope that we will be able to publish the results at the end of the 2017.
We have finalised the analyses plan which you can look at here (PDF, 696kB)
Frequently Asked Questions
Why is research in children needed?
Over 250 children a year already attend Lightning Process training. It is important that people know whether it is safe and effective or not. We need high quality research to answer these questions.
Should research be done in children before adults?
Children have the right to research particularly in illnesses which are different to adults. CFS/ME in children has a different outcome to adults and the treatment is different therefore research in adults cannot be extrapolated to children.
How can we take part in the study?
We have finished recruiting in to SMILE.
What ethical review has SMILE received?
The ethical approvals received are documented in the Protocol.
The SMILE study is compliant with Good Clinical Practice Guidelines, Research Governance Framework, Medical Research Council guidelines, Royal College of Paediatrics and Child Health guidelines for the conduct of trials.