The period in which we can recruit new families into the Click-East trial is coming to an end in January 2013 so my big priority right now is to see as many families as I possibly can. This blog aims to look at the reasons why recruitment can be so tricky, particularly in the final phases of a trial, and why we can’t be flexible on the date that recruitment has to stop.
One of the main ways we’re going to be measuring the effectiveness of our app, is using an assessment called the Autism Diagnostic Observation Schedule, or ADOS. The ADOS is a play-based assessment, so to the child it feels like just playing a series of games with an adult. This include free play, play with bubbles and balloons, and a pretend birthday party for a baby doll. During these games, I’m observing how the child relates to me and the toys, what spontaneous language and non-verbal communication they use, and whether they exhibit any repetitive or sensory behaviours, like lining things up, hand-flapping, or peering at things very closely. All of these behaviours are scored, with children receiving a score of zero for a behaviour which is perfectly “normal” and a score of up to three for a behaviour which seems strongly autistic.
The ADOS is a great tool for assessment of autism features, both for research and during diagnosis. However it isn’t perfect as an outcome measure for intervention studies like ours, because you can’t do two ADOSes close together. The children remember you and remember the games and so sometimes they will exhibit fewer autism-like behaviours. The whole point is to try to introduce some social challenges to the child (like blowing bubbles and then stopping and doing nothing so they have to ask for some more) and this doesn’t work well if the child remembers you doing it last time! So, in terms of our study design, we have arranged that families enrolled in the trial are seen six months apart, even though they only get two months with the iPad. Our funding runs out at the end of June 2013, so already people we see in January will have to be followed-up in June only 5 months later, instead of the full six. This is not too bad as it will only affect a handful of participants, but we certainly can’t squeeze in anyone in February or later.
So far, I have seen 41 families out of the 60 we initially hoped to get involved. Six of these families turned out not to be eligible for the trial, which is an issue I’ve discussed in a previous blog post. That leaves 35 enrolled in the research and there are another 12 “on the books” awaiting their first assessment. If I can see all of them before Christmas, I’ll be really pleased but time is running out. With other kids, work, nursery times and so on it can be very hard to find a session (two hours long!) which suits each new participant. Not to mention the potential for bad weather, and the fact that kids (and parents) at this time of year regularly come down with some bug or another. Another complication is the fact that a large proportion of local parents who are particularly keen about our research, or who have children who seem perfectly suited to what we’re doing, they came forward right at the beginning. To some extent, we are now trying to recruit people who are maybe less enthusiastic about the research process, or aren’t convinced about the use of technology.
It can be very challenging, but I am confident that even if we don’t hit our target of 60 participants, we will have a good sample size. Not to mention some really excellent links with local families and other members of the autism community. I’d like to quickly take this opportunity to thank everyone who has supported our recruitment process, and of course all the families who have, and continue to come forward to be involved. Thank you!