Austin Regional Clinic Recruiting Families for Clinical Trial Testing Mobile Device to Aid Autism Diagnosis in Young Children
The results of the clinical trial will be submitted to the FDA.
Austin, Texas, Jan. 23, 2020 (GLOBE NEWSWIRE) -- Austin Regional Clinic (ARC) is partnering with Cognoa, a leading pediatric behavioral health company, on a national multi-site clinical trial to test the performance of a new diagnostic device for autism spectrum disorder (ASD). The digital diagnostic device is intended to help pediatricians and primary care physicians make an autism diagnosis in children as young as 18 months old, over two and a half years earlier than the current standard of care. Earlier identification of ASD can enable treatment sooner, when there is the greatest potential to influence behavioral health and brain development.
ARC is the only medical group in Austin selected to participate in this groundbreaking study and is encouraging parents and guardians with children ages 18 to 71 months, who have concerns about their child’s development to visit https://tx.cognoastudy.com/ and complete a simple form to determine if they are eligible to participate. The results of the clinical trial will be submitted to the FDA. If cleared, this device would become the first FDA-cleared medical device to help diagnose autism.
“With the help of innovative technologies like Cognoa’s, we can more rapidly take action on parental concerns and identify and diagnose autism, creating a more proactive approach to pediatric behavioral healthcare,” said Dr. Jacques Benun, ARC pediatrician and principal investigator for the Cognoa Autism Research Study.
Currently, the average age that autism is diagnosed is 4 years and 4 months which is after the primary window of brain development when interventions can have the greatest impact. While the advantages of early intervention are well researched, access to timely care is a persistent challenge. Parents who develop behavioral concerns and/or notice developmental delays do so when their child is around 13 months of age, yet they are often required to wait for one to three years to receive the proper diagnosis and treatment due to a growing shortage of behavioral health specialists.
How Does it Work
Participants are asked to complete a parental questionnaire and submit two short videos via the Cognoa Research app. In addition, a child and their parent or caregiver must complete two doctor’s appointments (one with a pediatrician and one with a specialist). There is no cost to parents for these appointments.
Parents and guardians with children ages 18 to 71 months, who may have concerns about their child’s development, are encouraged to visit https://tx.cognoastudy.com/ to complete a simple form to determine if they are eligible to participate in the trial or call ARC Research Coordinator at 737-247-7245. Eligible families that complete all steps of the study will receive $200 in compensation.
About the Cognoa Diagnostic Device
The diagnostic device applies proprietary machine learning technology to parental and physician inputs, analyzing them for current and predictive autism signals. These powerful insights, combined with the physician’s own clinical observations, are designed to enable physicians to make more timely, informed, and accurate clinical diagnoses and decisions about patient care.
Cognoa’s ASD diagnostic has received FDA Breakthrough Device designation, providing priority review for clearance by the FDA. Cognoa’s ASD diagnostic received Breakthrough designation because of its potential to help physicians provide a more timely, accurate diagnosis, for which no approved alternative currently exists.
About the Cognoa Autism Research Study
The Cognoa Autism Research Study is a prospective, multisite, blinded, active comparator study. To qualify for participation in the study, a child needs to be between the ages of 18 and 71 months and the parent or pediatrician must have a concern about the child’s development. A child cannot participate if they have received a formal diagnosis of autism. As part of the study, parents will need to provide information about their child’s behavior by completing a questionnaire and uploading two short videos using Cognoa’s mobile app. In addition, a child and their parent or caregiver will need to complete two doctor’s appointments (one with a pediatrician and one with a specialist). There is no cost to parents for these appointments.
About Austin Regional Clinic
Austin Regional Clinic (ARC) is a multispecialty medical group committed to providing comprehensive healthcare services throughout the greater Austin area. Founded by three physicians in 1980, ARC now provides health care to over 500,000 area residents in 27 locations in 11 cities, including both primary and specialty care. ARC is unique to the Central Texas area because of the widespread locations, convenient services, and quality assurance programs. ARC patients enjoy access to such conveniences as same-day appointments, 24/7 online and phone appointment scheduling, ARC MyChart patient portal, After Hours Clinics, and nursing services through the night. Most ARC clinics also offer on-site radiology and lab services and some clinics offer specialty programs such as a travel clinic and Healthiness program. For more information, visit www.austinregionalclinic.com.
About Cognoa, Inc.
Cognoa is advancing the standard of pediatric behavioral healthcare with digital therapeutics and medicines that enable earlier identification, diagnosis and treatment for improved lifelong outcomes. Our lead prescription products, the first digital diagnostic aid and the first prescription digital therapeutic for autism, have both received Breakthrough Device designation from the FDA. Cognoa’s product pipeline addresses other indications including ADHD and anxiety. Available today through employers, health plans and treatment providers, the Cognoa for Child Development app has been used by more than 300,000 parents to screen for risk of developmental delays, track and support their child’s developmental health. For more information, visit www.cognoa.com.
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Helen Shik Cognoa 6175104373 [email protected]