MENTIS Personal Health Record Rapid Pilot Research Deployment and Evaluation

Autism Spectrum Disorder (ASD) is a collection of complex neurodevelopmental disorders characterized by qualitative impairments in socialization, communication, and circumscribed interests, including stereotypical behavior patterns and behavioral rigidity to changes in routines (American Psychiatric Association, 1994). ASD is the fastest growing pervasive developmental disorder of childhood, currently estimated to affect 1 in 88 school age children (Baio, 2012). ASD typically manifests in infancy and persist throughout the lifespan. There is no known cause or cure for ASD, yet structured behavioral interventions and medications can enhance developmental outcomes. ASD has a profound impact on families and often result in enormous emotional and financial costs. Recent estimates suggest that societal costs in the US to care for all individuals diagnosed each year over their lifetime approaches $35 billion (Ganz, 2007). Janssen Research \& Development is building a comprehensive digital platform (MENTIS) to optimize and enhance development of novel medicines and track outcomes in individuals with ASD. The MENTIS platform contains several core components, including: (1) An electronic personal healthcare record, designed specifically for individuals with ASD and their caregivers (parents, teachers, healthcare providers); (2) Integrated physiological and physical activity biosensors designed to objectively assess outcomes important in ASD, and; (3) A de-identified research data warehouse with analytic tools to better measure outcomes, assist with sub-population identification, and identify algorithms for diagnosis and treatment response detection. The MENTIS platform is currently being designed, developed, and prepared for testing. During this process it is highly desirable to conduct feasibility and usability research with a sample of the target population to identify important system components and features, optimize design, and reduce redundancy in software developmen