MENTIS Personal Health Record Rapid Pilot Research Deployment and Evaluation
Condition: Autism
Study type: Observational

Summary: 
      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 development and research time. The rapid
      pilot study described herein is proposed to gather incipient feedback on select MENTIS system
      components and features from stakeholders who support individuals with ASD in a clinical
      setting. This pilot research will help evaluate both how well current MENTIS system features
      work in an applied setting and inform future directions for MENTIS platform development.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Group 1: Six (6) students from the Discovery School and their respective support staff.
        Inclusion criteria include a diagnosis of ASD and enrollment in the Discovery School due to
        frequently observed challenging behaviors. Reporters will include: 2 teachers, HCP and
        parent/guardian.

        Group 2: Fourteen (14) students receiving services from Center for Discovery (but outside
        the Discovery School), their respective support staff, and, for those who live at home,
        their parents. Inclusion criteria includes a diagnosis of ASD, seven (7) students who
        reside in a CfD provided campus home, and seven (7) students who reside in the local
        community with their parents. Reporters will include: 2 teachers, HCP, residential staff
        and parents.

        Stakeholders: Healthcare professionals, classroom teachers, residential staff, and parents
        who support students with ASD in Groups 1 and 2 above.
      
Keywords: autism