Recruitment is now closed for the Click-East study, and over the next seven days myself and my research associate will be seeing a last seven families who would like to enrol. After that, the doors are shut however, and unfortunately we have to be really strict on this. Our funding expires at the end of June – even if there is cash in the grant account we haven’t spent at that date, it will return to the funding body, The Nuffield Foundation, who originally sponsored the research. The design of the trial means that participating families come in for a face to face assessment at the start (known as Time 1) and again at the end (Time 4 in this case) and these assessments are supposed ot take place six months apart. The families coming in for their T1 assessment in January are already going to have a five instead of a six month gap and there’s no way we can reduce that further.
Why is the gap important? Two reasons: first, the assessments we do are sensitive to the effects of memory. So if a child has a clear memory of having done the assessment before, that will change their behaviour and their score, which could lead to us drawing false conclusions from the study. For example, during the ADOS (autism diagnostic observation schedule) I play at having a pretend birthday party for a doll. If the child spontaneously uses the doll in a creative way – like feeding it some pretend birthday cake, or making it cry and giving it a hug – they get a better score than if they merely copy me doing those things. But if they can remember their previous visit, when we played the same game, they might appear to be doing something original which is actually copied from the last time they came in. The second reason is that for any intervention – even one as modest as the app we’ve designed – is going to be any good then it needs to have positive effects that last. So that’s why our primary outcome measure is based on the child’s abilities six months after they first come in, even though access to the intervention stops after two months.
This is an exciting time for me as a researcher. Once we have finalised our sample, I can start to work out the baseline stats. I’ll explore the differences between the groups – because children have been randomly assigned to either receive the intervention immediately or wait until after their T4 visit we don’t know yet whether the groups are similar. So I need to check average scores for things like autism severity, language ability and demographics such as socio-economic status. Hopefully our two groups will be quite similar and that will help us to decide, if there is a difference in outcome between the groups, whether this difference can be reliably attributed to our intervention. Crossed fingers!
