Stephen Bent’s primary goal in this project was to determine whether a randomized, controlled trial of a treatment for children with autism could be conducted entirely over the phone and Internet. He and his team designed an Internet-based clinical trial platform within the Interactive Autism Network (IAN), an online community and longitudinal study of more than 13,000 families that include a child with autism.
Bent and his colleagues at the University of California, San Francisco and the Kennedy Krieger Institute in Baltimore used omega-3 fatty acid supplementation as the treatment because previous studies show that it is safe and potentially useful for reducing hyperactivity.
All study procedures, including email recruitment, screening of children for an accurate diagnosis and eligibility criteria, completion of informed consent, and collection of baseline and outcome measures, took place over a secure Internet connection. The researchers also asked teachers to complete online assessments of the children’s behavior. The researchers sent study medications by overnight mail to the participants, and contacted each participating family by phone to answer questions and review study procedures.
After six weeks of recruitment, 57 children and their teachers from 28 states enrolled in the study, and 100 percent of participants completed all outcome measures. After six weeks of treatment, children in the omega-3 group showed greater decreases in both parent- and teacher-rated measures of hyperactivity compared with children in the placebo group, but the differences were not statistically significant.
The major finding of this study was that Internet-based clinical trials in children with autism are feasible and have the potential to dramatically reduce the cost and time required to complete high-quality randomized, controlled trials. This method also allows families from any location, including rural areas, to participate. Bent believes that this technique has the potential to efficiently provide good evidence for commonly used complementary and alternative therapies for autism (e.g., probiotics, vitamin D, vitamin B12).