MENTIS Personal Health Record Rapid Pilot Research Deployment and Evaluation
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 5 - 20 |
| Updated: | 4/8/2017 |
| Start Date: | November 2013 |
| End Date: | October 2014 |
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.
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.
Inclusion Criteria:
Student Participants:
- Meet standard classroom selection criteria of age, gender, intellectual ability,
communication ability and behavioral characteristics (frequency and duration of
maladaptive behaviors).
- Be enrolled at Center for Discovery, have a Behavioral Intervention Plan (BIP), and
an Individualized Education Plan (IEP).
- Have a diagnosis of autism.
- Be between the ages of 5 and 21 years, inclusive.
- Tolerate wearing physiological wrist, ankle, and chest monitors.
Residential and School Staff:
- Employed at The Center for Discovery.
- Meet Center for Discovery requirements for working with students in the classroom or
residence and have experience in teaching or intervening with students who exhibit
maladaptive behaviors.
- Willing to consent to add data to the system via the supplied tablet for the duration
of the study.
- Willing to consent to participate in either focus groups or individual interviews
about their experience of using the system and to be video recorded doing so.
Parent Participants:
- Be the parent or legal guardian of one of the 20 students enrolled in the study.
- Willing to consent to add data to the system via the supplied tablet for the duration
of the study.
- Willing to consent to participate in either focus groups or individual interviews
about their experience using the system and to be video recorded doing so.
Exclusion Criteria:
Student Participants:
- Younger than 5 years at the start of the school year.
- Not reach the age of 21 years prior to the end of the school year during which the
study will take place.
- Not enrolled at Center for Discovery.
- Do not tolerate wearing physiological monitors after repeated trials of modeling,
desensitization, shaping, and reinforcement.
Residential and School Staff:
- Have not been employed for at least one year prior to participating in the study.
- Do not consent to adding data.
- Do not consent to participant in focus groups or interviews.
- Do not consent to being recorded during focus groups or interviews.
Parent Participants:
- Are not the parent or legal guardian of one of the student enrolled.
- Do not consent to participate in either focus groups of individual interviews about
their experience using the system and to be video recorded doing so.
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