Effectiveness of omega-3 fatty acids for the reduction of hyperactivity in children with autism spectrum disorder

The primary research question is as follows: Do Omega-3 fatty acids reduce hyperactivity in children with autism? In order to answer this question, this study will assess changes in hyperactivity as measured by the Aberrant Behavior Checklist (ABC) in children with ASD and elevated baseline levels of hyperactivity who are randomly assigned to use 1.3 grams of omega-3 fatty acids daily compared to placebo.

This study will also assess changes in social functioning (using the Social Responsiveness Scale), overall disease severity (using a modified Clinical Global Impression – Improvement score), and side effects in children taking omega-3 fatty acids vs. placebo.

The secondary objective is to improve and upgrade existing infrastructure of the Interactive Autism Network (IAN) to allow for the efficient and smooth conduct of internet-based RCTs of interventions for ASD. This study will be conducted entirely over the internet.

Existing participants of IAN Research who meet baseline inclusion and exclusion criteria will be invited to participate in the study. Families meeting all eligibility criteria will be randomly assigned and mailed a packet of Omega-3 or placebo which will be administered to children twice daily for six weeks. Assessment of child hyperactivity, social functioning, and overall disease severity will be measured at baseline, three and six weeks. Side effects will be assessed at weeks three and six. Parents will also receive a weekly e-mail reminder and will be asked to log the medication that was provided to their children each day of the previous week.