Researchers at UC San Francisco have completed the first online randomized clinical trial for children with autism. The study, published in the June 2014 issue of Journal of the American Academy of Child and Adolescent Psychiatry, evaluated the effectiveness of omega 3 fatty acids in reducing hyperactivity in children with autism.
While the study did not show a statistically significant improvement in hyperactivity, it did prove that online clinical trials can be a reliable, cost and time-effective means of evaluating children with autism.
Lead author Stephen Bent, associate professor of medicine at UCSF, said, “Recruitment in clinical trials in children with autism is one of the biggest challenges we face in studying potential treatments, and we found that process to be accelerated and streamlined by using existing online communities for enrollment.”
The study used the Interactive Autism Network’s (IAN) online community of parents to recruit 57 children from 28 states. The children were randomly assigned to receive 1.3 grams of omega 3 fatty acids or a placebo for six weeks. Parents filled out an online questionnaire once a week detailing their child’s response to the medication. The children’s teachers also participated via online questionnaires.
“The entire study was completed in slightly more than three months from the start of enrollment, and demonstrates there are many advantages including low cost, rapid enrollment, high completion rate, convenience for participating families, and the ability to participate from virtually any location,” said Bent. “We had 100 percent completion of all outcome measures from parents and teachers, indicating that there is an ease to this method of testing that engages parents at a higher rate than traditional tests.”
The online format reduced many of the challenges normally associated with conducting a clinical trial study, especially those regarding recruitment and participant follow-through. In traditional studies, researchers often need to evaluate potential participants prior to the study, to make sure they actually have the qualifying diagnosis. Using the IAN database, which requires a doctor’s diagnosis from all participants, allowed researchers to bypass this step.
Travel is another obstacle for many families. It is usually necessary for the research team to cover travel expenses for familes, which raises the cost of the study. Many families are also unable to participate due to behavioral issues which can make it difficult for them to travel with their child.
The pre-existing database of qualified families, along with the convenience of online communication, created a simple format that allowed parents and teachers to respond at times that were convenient for them, leading to a 100 percent response rate.
While certain types of studies may not be suitable to the online model, it seems that many could benefit from the time-saving, cost-effective method of research. Studies that show promise online may point the way towards methods that deserve further research in more traditional formats, allowing more money to be allocated towards research that is likely to make a real difference for those living with autism.