Autism Intervention Research Network on Physical Health (AIR-P) Update
December 10, 2013
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The Combating Autism Act Initiative (CAAI) has a goal of advancing research in treatment of autism spectrum disorders (ASD). The Autism Intervention Research Network on Physical Health (AIR-P) provides a network infrastructure to conduct multi-site research, clinical trials, and observational/intervention studies dedicated to improving the health and well-being of individuals with ASD. For more information on the AIR-P, please visit us at: www.autisminterventionresearch.net
Until the development of the AIR-P, no focused and dedicated strategy existed to support a portfolio of clinical research directed toward these conditions. Half of the current AIR-P funding is dedicated to protocol-driven clinical research. When the AIR-P competed successfully with renewed funding in 2011, the network proposed support for 2 new studies, both randomized clinical trials.
RESEARCH ACTIVITIES
The first study, "Treatment of Overweight Induced by Antipsychotic Medication in Young People with ASD" addresses the problem of significant weight gain among children taking atypical antipsychotic medications.
The investigators propose to: 1) evaluate the safety and efficacy of treatment with oral metformin vs. placebo to decrease weight or weight gain associated with atypical antipsychotic medication in children (ages 6-17 years, 4 months) with ASD; and 2) evaluate the long-term safety and efficacy of metformin by offering 16 weeks of open-label treatment with metformin to all subjects after Part I.
Children are randomized to treatment with metformin or placebo. If the metformin is well tolerated for 2 weeks, the dose is increased as per schedule and based on age. The randomized phase (efficacy phase) lasts 16 weeks followed by an optional 16 week open-label phase (continuation phase). A liquid preparation is used because some children with ASD have difficulty swallowing pills.
Up to 90 children will be recruited and randomized from each of four sites: Ohio State University's Nisonger Center, Vanderbilt University, Bloorview Research Institute (University of Toronto), and Western Psychiatric Institute and Clinic (University of Pittsburgh Medical Center).
The second study, "Iron Treatment of Sleep Disorders in Children with Autism Spectrum Disorders" addresses the effect of iron supplementation on restless legs syndrome and periodic limb movement of sleep.
The investigators propose to: 1) evaluate the effect of treatment with oral elemental iron (supplied as ferrous sulfate) vs. placebo on sleep in children (ages 2-10 years, 11 months) with ASD, insomnia and ferritin levels between 17 and 49ng/ml; 2) evaluate periodic limb movement index (PLMI) as a predictor and mediator of response to iron for insomnia in children with ASD, as measured by actigraphy; and 3) evaluate daytime behavior and quality of life before and after treatment with iron.
Children are randomized to treatment with iron/placebo 3mg/kg/day divided twice per day for 3 months, using a liquid preparation given that some children with ASD have difficulty swallowing pills. Up to 260 subjects will be screened, 181 to 220 subjects will be enrolled, and 124 subjects will be randomized from each of four sites: University of Colorado (Denver, CO); Vanderbilt University Medical Center (Nashville, TN); Hospital for Sick Children (Toronto, Canada); and University of Rochester Medical Center (Rochester, NY).
In addition to these 2 signature initiatives, the AIR-P supports 6 ongoing studies in the areas of GI, toileting, sleep, and health services research. Since 2008, the AIR-P has initiated a total of 17 research studies, with topics including nutrition, GI, metabolism, sleep, outcome, neurology, immunology, psychopharmacology, and health services. Registry and research findings have been represented through more than 39 manuscripts in medical journals and more than 75 abstracts/posters at scientific meetings.
To date, more than 1,600 subjects have participated in AIR-P research studies - many of whom were identified through the Registry of the Autism Speaks Autism Treatment Network (AS ATN). The Registry now includes almost 7,000 individuals with ASD, ages 2 - 18 years. Each subject undergoes an extensive assessment battery (ADOS, medical evaluation, Child Sleep Habits Questionnaire, cognitive testing, etc.) as well as identifying any co-morbid medical conditions
QUALITY IMPROVEMENT & TOOLS
The 14-site Autism Intervention Research Network for Physical Health (AIR-P) has improved medical care for children with ASD through a breadth of activities including research, quality improvement, training, community conferences, family engagement, guideline development and tool development.
We have radically changed clinical care for children with ASD at AIR-P sites. Through our quality improvement initiative, providers are collaborating across sites to apply evidence-based practice in the areas including insomnia, constipation, and anti-psychotic medication monitoring. Two AIR-P sites (Cincinnati Children's Hospital and Nationwide Children's Hospital) have successfully improved access to care by reducing the waitlist by 96% and reducing the wait for a new visit for younger children by 73%, respectively. AIR-P centers have implemented systems to ensure that all children receive a standard review of systems to identify key medical co-morbidities, including insomnia and constipation; and to ensure that children on anti-psychotic medications are appropriately monitored. We have released a range of toolkits to support both families and providers in caring for children with ASD. Tools released in the past year have covered topics including constipation, insomnia and safe medication use.
GUIDELINES
We have developed and published three robust practice guidelines (Pediatrics supplement, November 2012) with existing evidence from the literature aided by expert consensus in the areas of insomnia, constipation, and medication choice. Three additional guidelines utilizing systematic literature reviews are currently in development for treatment of irritability and agitation in children with ASD, treatment of anxiety in children with ASD, as well as for electroencephalography (EEG) and epilepsy in children with ASD.
WEBINAR SERIES
We continue our monthly AS ATN/AIR-P Advances in Autism Research & Care Webinar Series, and offer 1 continuing medical education credit for each webinar. Each month alternates autism research and care themes for a variety of topics, and many of the webinars feature current AS ATN / AIR-P research study principal investigators. Recent presentations have covered genetics, psycho-pharmacology, discussion of DSM5, and an overview of our Network Registry data. Future topics will likely include coding and billing; the gut microbiome; obesity and nutrition; transition, adolescence and puberty; as well as AIR-P research progress and successes. The webinar presenters and attendees greatly benefit from the exchange with others, and have generated much discussion on key topics in the field with increasing participation. These webinars are open to all LEND, DBP and CAAI programs and are announced through various CAAI and AUCD list serves each month.
