Internet-Based, Randomized, Controlled Trial of Omega-3 Fatty Acids for Hyperactivity in Autism

Abstract

Objective Preliminary evidence suggests that omega-3 fatty acids may reduce hyperactivity in children with autism spectrum disorder (ASD). We sought to examine the feasibility of a novel, internet-based clinical trial design to evaluate the efficacy of this supplement. Method E-mail invitations were sent to parents of children aged 5-8 enrolled in the Interactive Autism Network. All study procedures, including screening, informed consent, and collection of outcome measures took place over the internet. The primary outcome measures were parent- and teacher-rated changes in hyperactivity on the Aberrant Behavior Checklist. Results During the 6-week recruitment period, 57 children from 28 states satisfied all eligibility criteria and were randomly assigned to 1.3 grams of omega-3 fatty acids or an identical placebo daily for 6 weeks. Outcome assessments were obtained from all 57 participants and 57 teachers, and the study was completed in 3 months. Children in the omega-3 fatty acid group had a greater reduction in hyperactivity (-5.3 points) compared to the placebo group (-2.6 points), but the difference was not statistically significant (1.9 point greater improvement in the omega-3 group, 95% CI -2.2 to 5.2). Side effects were rare and not associated with omega-3 fatty acids. Participant feedback was positive. Conclusion Internet-based randomized controlled trials of therapies in children with ASD are feasible and may lead to marked reductions in the time and cost of completing trials. A larger sample size is required to definitively determine the efficacy of omega-3 fatty acids. Clinical trial registration information—Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder; http://clinicaltrials.gov; NCT01694667.

Examining Clinics for Children with Autism: The Autism Translating To Treatment Study

“…The Social Responsiveness Scale (SRS) was chosen; this instrument has been used in recently published randomized controlled trials of interventions for ASD. 21,22 Also selected were instruments that assessed symptoms or other key variables in the following areas: sensory sensitivity, language, gastrointestinal (GI) symptoms, pediatric quality of life, and caregiver strain. In addition, a detailed form was developed to obtain the medical history for each child (including birth and family history, medical problems, prior medications, CIM, and other treatments) (Fig.…”

Omega-3 supplementation in autism spectrum disorders: A still open question?

“…[6789] The empirical value of a case report like ours is obviously not comparable to that of a randomized clinical trial, primarily due to the risk of mistakenly considering a placebo effect as a real effect of the drug. We were aware of this possible bias when describing our case.…”

Systematic review and guide to management of core and psychiatric symptoms in youth with autism

“…A recent small study of omega‐3 fatty acid treatment vs. placebo, with low risk of bias, found no statistically significant difference in hyperactivity as measured by ABC‐H (parent and teacher), although treatment was well tolerated . Finally, a 4‐arm study ( n = 128 total) compared atomoxetine alone, atomoxetine plus parent‐training, placebo plus parent‐training and placebo treatments.…”

“…Four studies (Table a‐c) met inclusion criteria for targeting ADHD symptoms in ASD. Two trials tested pharmacological , one tested a biomedical , and one tested a combined intervention approach . In Scahill et al.…”