Autism Clinical Trial - MENTIS Personal Health Record Rapid Pilot Research

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Autism

Clinical Trial Details

NCT number	NCT02090491
Study type	Observational
Source	Northeastern University
Contact
Status	Completed
Phase	N/A
Start date	November 2013
Completion date	October 2014

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05302167` - Molehill Mountain Feasibility Study.	N/A
Completed	`NCT04167839` - Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement	N/A
Terminated	`NCT04049981` - Investigation of Mechanisms of Action in Superpower Glass	Phase 1/Phase 2
Active, not recruiting	`NCT06080087` - Implementation Toolkit to Enhance EBP Among Marginalized Families	N/A
Recruiting	`NCT04107064` - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program	N/A
Completed	`NCT03206996` - Exposure Therapy for Auditory Sensitivity in Autism	N/A
Completed	`NCT01914393` - Pediatric Open-Label Extension Study	Phase 3
Completed	`NCT05588570` - Coaching Children With Anxiety and Autism Through Telehealth	N/A
Enrolling by invitation	`NCT06058104` - Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism	N/A
Completed	`NCT03002363` - The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance	Phase 1
Completed	`NCT02911194` - a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD)	N/A
Withdrawn	`NCT02414451` - Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response	N/A
Completed	`NCT02847182` - Cord Blood Infusion for Children With Autism Spectrum Disorder	Phase 2
Completed	`NCT02536365` - Sensory Integration Therapy in Autism: Mechanisms and Effectiveness	N/A
Completed	`NCT02508922` - Trial of Vitamin D3 Supplementation in Paediatric Autism	N/A
Completed	`NCT02720900` - Prebiotic Intervention for Autism Spectrum Disorders	N/A
Completed	`NCT02708290` - Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
Recruiting	`NCT02255565` - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study	Phase 4
Recruiting	`NCT01836562` - A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism	Phase 1/Phase 2
Completed	`NCT02154828` - Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

MENTIS Personal Health Record Rapid Pilot Research Deployment and Evaluation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms