Safety and Efficacy of Complimentary and Alternative Medicine Treatments for Young Autistic Children

Background: Autism is a common disorder of brain functioning characterized by stereotyped behavior, deficits in language functioning, and social reciprocity. Despite the availablility of efficacious standard treatment with behavior therapy and psychopharmaceuticals, most children with autism continue to have significant developmental impairments. As a result, the parents of many autistic children use some form of Complimentary and Alternative Medicine (CAM) in hopes of further ameliorating symptoms.

The Pittsburgh Integrative Autism Treatment Study Group is a unique interdisciplinary group at the University of Pittsburgh consisting of developmental-behavioral pediatricians, psychologists, a child psychiatrist, a dietitian, and PhD research scientists who also happen to parents of young childrren with autism. Members of the group include UCLID faculty and associate faculty. This group was formed in response to the increasing use of CAM therapies among young autistic children, to study whether these therapies are safe and effecive in reducing symptoms. Phase one involves open label studies of potentailly useful therapies recommended by our interdisciplinary study group. Phase one data will be used to obtain funding for double-blind clinical trials (phase two) and the study of neurobiological mechanisms underlying improvement in symptoms (phase three), through the National Center for Complementary and Alternative Medicine (NCCAM) branch of the NIH.

Method: To assess the safety and efficacy of two potentially useful CAM therapies, the gluten-free casein-free diet (gfcf) and the omega-3 fatty acid (O-3) supplements, among young children with autism.

Design: An open label cross-over study. Subjects: 80 children age 30-54 months with an autistic spectrum disorder will randomly receive one of the following treatments for three months and then will cross over to receive a second treatment for three months: 1) a "placebo" sugar restrdcited diet, 2) the gfcf diet, 3) O-3 supplement and the the combined gfcf diet plus O-3 supplement.

Data Collection: Videotaped standardized patient interactions and semi-structured interview techniques at baseline, 3 and 6 months will elicit efficacy outcomes including overall change in severity of autistic symptoms, change in core features of autism, change in parental rated target symptoms. Safety outcomes will include biochemical markers of nutrition, adequacy of nutritional intake and anthropometric measurements. Adherence measures include biochemical markers of dietary compliance, logs of dietary infractions, and diet recall diaries.

Significance: Given that many parents of children are already using CAM therapies, research that clarifies whether a specific CAM therapy is efficacious for children with autism has clear clinical relevance. Current therapies rarely result in a complete remission of symptoms. Additionally, scientific advances in understanding the etiology of autism may be possible by studying the neurobiological mechanisms underlying effective CAM therapies.

For more information, please contact Meg Mayer-Costa MS, RD, LDN at mmm41@pitt.edu.