An Observational Study With the Janssen Autism Knowledge Engine (JAKE®) in Individuals With Autism Spectrum Disorder

Objective: The Janssen Autism Knowledge Engine (JAKE®) is a clinical research outcomes assessment system developed to more sensitively measure treatment outcomes and identify subpopulations in autism spectrum disorder (ASD). Here we describe JAKE and present results from its digital phenotyping (My JAKE) and biosensor (JAKE Sense) components.Methods: An observational, non-interventional, prospective study of JAKE in children and adults with ASD was conducted at nine sites in the United States. Feedback on JAKE usability was obtained from caregivers. JAKE Sense included electroencephalography, eye tracking, electrocardiography, electrodermal activity, facial affect analysis, and actigraphy. Caregivers of individuals with ASD reported behaviors using My JAKE. Results from My JAKE and JAKE Sense were compared to traditional ASD symptom measures.Results: Individuals with ASD (N = 144) and a cohort of typically developing (TD) individuals (N = 41) participated in JAKE Sense. Most caregivers reported that overall use and utility of My JAKE was “easy” (69%, 74/108) or “very easy” (74%, 80/108). My JAKE could detect differences in ASD symptoms as measured by traditional methods. The majority of biosensors included in JAKE Sense captured sizable amounts of quality data (i.e., 93–100% of eye tracker, facial affect analysis, and electrocardiogram data was of good quality), demonstrated differences between TD and ASD individuals, and correlated with ASD symptom scales. No significant safety events were reported.Conclusions: My JAKE was viewed as easy or very easy to use by caregivers participating in research outside of a clinical study. My JAKE sensitively measured a broad range of ASD symptoms. JAKE Sense biosensors were well-tolerated. JAKE functioned well when used at clinical sites previously inexperienced with some of the technologies. Lessons from the study will optimize JAKE for use in clinical trials to assess ASD interventions. Additionally, because biosensors were able to detect features differentiating TD and ASD individuals, and also were correlated with standardized symptom scales, these measures could be explored as potential biomarkers for ASD and as endpoints in future clinical studies.Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT02668991 identifier: NCT0266899

Of chickens and eggs: How a journal built a center and a field

This presentation will trace the development of the scientific history of alcohol studies in the United States from the early 1930's until the present as seen through the role and mission of the Center of Alcohol Studies (CAS). The CAS emerged from the faculty of the Laboratory of Applied Physiology at Yale University and has been located at Rutgers since 1962. Focusing on 75 years of the Journal of Studies on Alcohol and Drugs (formerly the Quarterly Journal of Studies on Alcohol and the Journal of Studies on Alcohol), the oldest alcohol/addiction research journal currently published in the United States, the history of the Center of Alcohol Studies will be used as a microcosm and prototype of research centers in the United States and elsewhere in the development and evolution of scientific approaches to study alcohol in all of its facets from molecular genetics to social policy and interventions

The Urgency of Doing: Assessing the System of Sustainable Implementation Model Via the Schools Implementing Towards Sustainability (Sits) Scale

School-based prevention and promotion interventions (SBPPI) improve desirable outcomes (e.g., commitment to school and attendance) and reduce undesirable outcomes (e.g., suspensions and violence). Unfortunately, our understanding of how to effectively implement and sustain SBPPI outside of well-controlled conditions is lacking. To bridge this science/ real world practice gap, a system of sustainable implementation, which merges implementation strategies and sustainability strategies, is proposed for SBPPI. Ecological levels and phases affect this system. This conceptualization is supported by analyses from a diverse sample of 157 schools implementing Social-Emotional Character Development, a type of SBPPI. The system of sustainable implementation was measured using the Schools Implementing Towards Sustainability (SITS) scale, which was designed to be user-friendly in field settings by being viable and scalable. The SITS demonstrated strong reliability as well as promising concurrent and construct validity. Implications are discussed

Risperidone and cognitive function in children with disruptive behavior disorders

Effects of risperidone on cognitive function in children with disruptive behavior disorders (DBDs) and subaverage intelligence quotient (IQ) were assessed. Data from two 6-week, double-blind, placebo-controlled studies (n = 228) were combined, as were three 1-year, open-label studies (n = 688). Patients with DBDs and subaverage IQ, 5 to14 years, received placebo or risperidone .02 to .06 mg/kg/day. Cognitive measures included the Continuous Performance Task (CPT) and Verbal Learning Test for Children (VLT-C). Efficacy was assessed using the Nisonger Child Behavior Rating Form (NCBRF). Adverse events were collected via spontaneous report; sedation was assessed using visual analog scale. Improvements on the NCBRF Conduct Problem subscale were significantly greater for risperidone- versus placebo-treated patients (-15.8 vs. -6.4, p < .0001) in short-term studies; significant reductions were observed in long-term studies (-16.3, p < .0001). No overall decline and some significant improvement in attention (CPT) and memory (VLT-C) were noted regardless of treatment in short-term studies. VLT-C improved significantly (p < .0001) for both groups, with no difference between treatment groups. Improvements in memory (VLT-C) and attention (CPT) were noted in long-term studies. Somnolence/sedation did not affect cognitive function. Cognitive function was not altered by risperidone in short-term studies and was maintained or improved with one year of treatment in children with DBDs and subaverage IQ, potentially representing age-appropriate gains