Variations in Administrative Approvals During the COVID-19 Pandemic at Participating Sites in the Society of Critical Care Medicine Discovery Network Viral Infection and Respiratory Illness Universal Study: COVID-19 Registry: A Cross-Sectional Study.

There is a paucity of literature regarding administrative approvals required for clinical studies during a pandemic. We aimed to evaluate variation in duration of administrative approvals within the Viral Infection and Respiratory illness Universal Study (VIRUS): A Global COVID-19 Registry. DESIGN SETTING AND SUBJECTS: Survey analysis of 188 investigators who participated in the VIRUS: COVID-19 registry, a prospective, observational global registry database of 287 sites. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: For each study site approved through December 8, 2020, we assessed the duration in days: 1) from institutional review board (IRB) submission to IRB approval, 2) from IRB approval to Research Electronic Data Capture (REDCap) access, 3) from REDCap access to first patient data entry in REDCap, and 4) total duration from IRB submission to first patient data entry in REDCap. Analysis of variance and Wilcoxon rank-sum test were used to compare time durations. Of 287 sites, 188 sites (United States = 155, non-United States = 33) provided complete administrative data. There was considerable variability in duration from IRB submission to first patient data entry with median (interquartile range) of 28 days (16-50 d), with differences not significantly different by country (United States: 30 [17-50] vs non-United States: 23 d [8-46 d]; p = 0.08) or previous "multisite trial experience" (experienced: 27 [15-51] vs not experienced: 29 d [13-47 d]; p = 0.67). The U.S. sites had a higher proportion of female principal investigators (n = 77; 50%), compared with non-U.S. sites (n = 7; 21%; p = 0.002). Non-U.S. sites had a significantly shorter time to first patient data entry after REDCap access: 7 (1-28) versus 3 days (1-6 d) (p = 0.02). CONCLUSIONS: In this Society of Critical Care Medicine global VIRUS: COVID-19 Registry, we identified considerable variability in time from IRB submission to first patient data entry with no significant differences by country or prior multicenter trial experience. However, there was a significant difference between US and non-U.S. sites in the time from REDCap access to first data entry.

COVID-19 infection differences among people with disabilities.

Purpose: People with disabilities may be at higher risk for COVID-19 infection and death as a result of their impairments and/or medical conditions, and systemic inequities and disadvantages. People with disabilities are also a very heterogenous group, with many people with disabilities being multiply marginalized. The aim of this study was to examine differences in COVID-19 diagnosis and vaccination between people with and without disabilities, and to explore sociodemographic differences in COVID-19 diagnosis and vaccination among the disability community itself. Methods: To do so, we analyzed secondary United States Census Bureau data from 444,422 people (52,890 adults with disabilities and 391,532 adults without disabilities) about COVID-19 diagnosis, vaccination, and sociodemographics. Frequency person-weights were applied. Results: In this study, 19.3% of adults with disabilities were diagnosed with COVID-19 during the pandemic compared to 16.7% of adults without disabilities. People with disabilities were 1.20 times more likely to be diagnosed with COVID-19 than adults without disabilities. Among people with disabilities, the following groups were more likely to be diagnosed with COVID-19: people with cognitive disabilities; cisgender women; Black people; Hispanic people; people with some college or associate's degrees; people with employer and/or private insurance; and people who lived in larger households. There was not a significant difference in vaccination between people with and without disabilities; however, there were vaccination disparities among the disability community. Conclusions: Many of the people with disabilities who were more likely to face health care disparities prior to the pandemic were also more likely to be diagnosed with COVID-19 during the pandemic.

Jordanian nurses' attitudes toward using electronic health records during COVID-19 pandemic.

Electronic health records (EHRs) have proven their effectiveness during the coronavirus disease (COVID-19) pandemic. However, successful implementation of EHRs requires assessing nurses' attitudes as they are considered the first line in providing direct care for patients. This study assessed Jordanian nurses' attitudes and examined factors that affect nurses' attitudes toward using EHRs. A cross-sectional, correlational design was used. A convenient sample of 130 nurses was recruited from three major public hospitals in Jordan. All Participants completed the Nurses' attitudes Towards Computerization (NATC) Questionnaire. The overall nurses' attitude was positive; the mean was 61.85 (SD = 10.97). Findings revealed no significant relationship between nurses' attitudes toward using EHRs and nurses' age, gender, education level, previous computer skills experience, years of work experience, and years of dealing with EHRs. However, the work unit was found to have a significant correlation with nurses' attitudes toward using EHRs. Therefore, nurse administrators should arrange for the conduct of educational workshops and continuous training programs considering the needs of the nurses.

Endobronchial blood-patch: A novel technique for a persistent pleural air leak.

Introduction: Patients with severe COVID-19 Pneumonia requiring prolonged mechanical ventilation have an increased incidence of pneumothorax. Mechanically ventilated patients who are critically ill and develop a persistent air leak from pneumothorax are poor candidates for surgical repair. As the persistent air leak can be a significant barrier to vent-weaning and clinical stability, these patients present a unique clinical challenge. Clinical case: A 65-year-old male intubated and on prolonged mechanical ventilation for severe COVID-19 Pneumonia developed a pneumothorax complicated by a persistent alveolar-pleural fistula with a persistent air-leak. Given his critical state with ongoing pressor requirements and elevated vent requirements, surgical repair was not an option. A bedside bronchoscopy occlusion study with isolation of the air leak, and subsequent autologous endobronchial blood-patch repair with thrombin was performed with rapid and definitive resolution of the air leak. The patient progressed favorably, ultimately being weaned from the ventilator, decannulated, and walking out of the hospital. Conclusion: In critically ill ventilated patients with pneumothorax complicated by a persistent air-leak, bedside endobronchial evaluation and blood-patch repair is a feasible approach to management.

Using Social Media for Clinical Research: Recommendations and Examples From the Brown-Lifespan Center for Digital Health.

Social media integration into research has increased, and 92% of American social media participants state they would share their data with researchers. Yet, the potential of these data to transform health outcomes has not been fully realized, and the way clinical research is performed has been held back. The use of these technologies in research is dependent on the investigators' awareness of their potential and their ability to innovate within regulatory and institutional guidelines. The Brown-Lifespan Center for Digital Health has launched an initiative to address these challenges and provide a helpful framework to expand social media use in clinical research.

Development and validation of a paper spray mass spectrometry method for the rapid quantitation of remdesivir and its active metabolite, GS-441524, in human plasma.

Introduction: Remdesivir (GS-5734) is a nucleoside analog prodrug with antiviral activity against several single-stranded RNA viruses, including the novel severe respiratory distress syndrome virus 2 (SARS-CoV-2). It is currently the only FDA-approved antiviral agent for the treatment of individuals with COVID-19 caused by SARS-CoV-2. However, remdesivir pharmacokinetics/pharmacodynamics (PK/PD) and toxicity data in humans are extremely limited. It is imperative that precise analytical methods for the quantification of remdesivir and its active metabolite, GS-441524, are developed for use in further studies. We report, herein, the first validated anti-viral paper spray-mass spectrometry (PS-MS/MS) assay for the quantification of remdesivir and GS-441524 in human plasma. We seek to highlight the utility of PS-MS/MS technology and automation advancements for its potential future use in clinical research and the clinical laboratory setting. Methods: Calibration curves for remdesivir and GS-441524 were created utilizing seven plasma-based calibrants of varying concentrations and two isotopic internal standards of set concentrations. Four plasma-based quality controls were prepared in a similar fashion to the calibrants and utilized for validation. No sample preparation was needed. Briefly, plasma samples were spotted on a paper substrate contained within pre-manufactured plastic cassette plates, and the spots were dried for 1 h. The samples were then analyzed directly for 1.2 min utilizing PS-MS/MS. All experiments were performed on a Thermo Scientific Altis triple quadrupole mass spectrometer utilizing automated technology. Results: The calibration ranges were 20 - 5000 and 100 - 25000 ng/mL for remdesivir and GS-441524, respectively. The calibration curves for the two antiviral agents showed excellent linearity (average R2 = 0.99-1.00). The inter- and intra-day precision (%CV) across validation runs at four QC levels for both analytes was less than 11.2% and accuracy (%bias) was within ± 15%. Plasma calibrant stability was assessed and degradation for the 4 °C and room temperature samples were seen beginning at Day 7. The plasma calibrants were stable at -20 °C. No interference, matrix effects, or carryover was discovered during the validation process. Conclusions: PS-MS/MS represents a useful methodology for rapidly quantifying remdesivir and GS-441524, which may be useful for clinical PK/PD, therapeutic drug monitoring (TDM), and toxicity assessment, particularly during the current COVID-19 pandemic and future viral outbreaks.

Exploring the potential of delivering mental health care services using digital technologies in Bangladesh: A qualitative analysis.

Background: Bangladesh is a lower-middle-income country affected by a severe lack of mental health service availability due to a scarcity of mental health experts, limited mental health literacy, and community stigma. In other low and middle-income countries, the online provision of mental health care services has addressed issues affecting service availability, accessibility, mass awareness of services, and stigma. Objective: The current study sought to understand stakeholders' perceptions of the potential of digital media-based mental health care delivery in strengthening Bangladesh's mental health system. Method: Online in-depth interviews were conducted with seven psychiatrists and eleven people with lived experiences of mental health issues. In addition, two online focus groups were conducted with ten psychologists and nine mental health entrepreneurs. A thematic analysis of the audio transcriptions was used to identify themes. Result: Stakeholders perceived that the benefits of digital media-based mental health services included the potential of increasing the awareness, availability, and accessibility of mental health services. Participants recommended: the rehabilitation of existing pathways; the use of social media to raise awareness; and the implementation of strategies that integrate different digital-based services to strengthen the mental health system and foster positive mental health-seeking behaviors. Conclusion: Growing mental health awareness, combined with the appropriate use of digital media as a platform for distributing information and offering mental services, can help to promote mental health care. To strengthen mental health services in Bangladesh, tailored services, increased network coverage, and training are required on digital mental health.

The NJ Alliance for Clinical and Translational Science (NJ ACTS) experience: Responding at “warp speed” to COVID-19

Introduction:The COVID-19 pandemic’s need for life-saving treatments and a "warp speed" vaccine challenged the National Institutes of Health’s Clinical and Translational Science Award (CTSA) recipients to improve their methods and processes in conducting clinical research. While CTSA recipient, New Jersey Alliance for Clinical and Translational Science (NJ ACTS), responded to this call to action with significant clinical research milestones, a comprehensive understanding of regulatory metrics during the COVID-19 pandemic is uncertain. The objective of this research is to identify, compare, and contrast metrics that illustrate the effectiveness of NJ ACTS’s research mobilization efforts during COVID-19.Methods:Data were collected from the Institutional Review Board (IRB), the Clinical Research Units (CRUs), and the Office of Research and Sponsored Programs (ORSP). IRB data detailed the volume and types of protocols approved and turnaround time (TAT) for approval in 2020 vs. 2019. CRU data examined study metrics of adult and pediatric clinical trials across 2018-2020. ORSP data documented awards received in 2019 and 2020Results:Analysis revealed a 95% increase in IRB-approved studies in 2020, with a significant decrease in TAT for COVID-19 studies. All CRUs observed a median 5.2-fold increase in the enrollment of adult and pediatric participants for COVID-19-related research. Study income was 106% and 196% greater than 2019 and 2018, respectively, with more than half funded through federal sponsors and 89% for COVID-19 trials. ORSP data revealed that 9% of awards and 26% of 2020 funding were COVID-19 studies.Conclusion:This study demonstrates that NJACTS effectively responded to challenges posed by the pandemic

COVID-Related Stress and Work Intentions in a Sample of US Health Care Workers.

OBJECTIVE: To evaluate relationships between coronavirus disease 2019 (COVID-19)-related stress and work intentions in a sample of US health care workers. PATIENTS AND METHODS: Between July 1 and December 31, 2020, health care workers were surveyed for fear of viral exposure or transmission, COVID-19-related anxiety or depression, work overload, burnout, and intentions to reduce hours or leave their jobs. RESULTS: Among 20,665 respondents at 124 institutions (median organizational response rate, 34%), intention to reduce hours was highest among nurses (33.7%; n=776), physicians (31.4%; n=2914), and advanced practice providers (APPs; 28.9%; n=608) while lowest among clerical staff (13.6%; n=242) and administrators (6.8%; n=50; all P<.001). Burnout (odds ratio [OR], 2.15; 95% CI, 1.93 to 2.38), fear of exposure, COVID-19-related anxiety/depression, and workload were independently related to intent to reduce work hours within 12 months (all P<.01). Intention to leave one's practice within 2 years was highest among nurses (40.0%; n=921), APPs (33.0%; n=694), other clinical staff (29.4%; n=718), and physicians (23.8%; n=2204) while lowest among administrators (12.6%; n=93; all P<.001). Burnout (OR, 2.57; 95% CI, 2.29 to 2.88), fear of exposure, COVID-19-related anxiety/depression, and workload were predictors of intent to leave. Feeling valued by one's organization was protective of reducing hours (OR, 0.65; 95% CI, 0.59 to 0.72) and intending to leave (OR, 0.40; 95% CI, 0.36 to 0.45; all P<.01). CONCLUSION: Approximately 1 in 3 physicians, APPs, and nurses surveyed intend to reduce work hours. One in 5 physicians and 2 in 5 nurses intend to leave their practice altogether. Reducing burnout and improving a sense of feeling valued may allow health care organizations to better maintain their workforces postpandemic.

The NJ Alliance for Clinical and Translational Science (NJ ACTS) experience: Responding at "warp speed" to COVID-19.

Introduction: The COVID-19 pandemic's need for life-saving treatments and a "warp speed" vaccine challenged the National Institutes of Health's Clinical and Translational Science Award (CTSA) recipients to improve their methods and processes in conducting clinical research. While CTSA recipient, New Jersey Alliance for Clinical and Translational Science (NJ ACTS), responded to this call to action with significant clinical research milestones, a comprehensive understanding of regulatory metrics during the COVID-19 pandemic is uncertain. The objective of this research is to identify, compare, and contrast metrics that illustrate the effectiveness of NJ ACTS's research mobilization efforts during COVID-19. Methods: Data were collected from the Institutional Review Board (IRB), the Clinical Research Units (CRUs), and the Office of Research and Sponsored Programs (ORSP). IRB data detailed the volume and types of protocols approved and turnaround time (TAT) for approval in 2020 vs. 2019. CRU data examined study metrics of adult and pediatric clinical trials across 2018-2020. ORSP data documented awards received in 2019 and 2020. Results: Analysis revealed a 95% increase in IRB-approved studies in 2020, with a significant decrease in TAT for COVID-19 studies. All CRUs observed a median 5.2-fold increase in the enrollment of adult and pediatric participants for COVID-19-related research. Study income was 106% and 196% greater than 2019 and 2018, respectively, with more than half funded through federal sponsors and 89% for COVID-19 trials. ORSP data revealed that 9% of awards and 26% of 2020 funding were COVID-19 studies. Conclusion: This study demonstrates that NJACTS effectively responded to challenges posed by the pandemic.

Defining the Role for Descending Pain Modulation and Reward-Aversion Processes Towards the Development of Chronic Pain in Endometriosis

Endometriosis, a condition in which uterine tissue grows outside the uterus, is a debilitating disease, affecting millions of women, is the leading cause of chronic pelvic pain (CPP), and is often unresponsive to existing treatments. Unfortunately, women's reproductive health has lacked investigation in biomedical research, which is warranted given that approximately 1 in 10 women worldwide have endometriosis. Further research on the biopsychosocial mechanisms contributing to endometriosis-associated pain is necessary to better inform treatment and prevention and is the goal of the current proposal. In respects to the COVID-19 pandemic, while recruitment and data collection have been stalled, the research team has used this time to publish several papers related to the project, including the publication of the projects first review paper, with another currently under review and three papers in preparation (two reviews;preliminary resting state data) along with attending various webinars and trainings related to the project. Currently due to COVID-19, research imaging has limits. During this time the research team has been discussing alternatives to counteract the setbacks that the project is currently facing. Recent discussion includes the following ideas: Reaching out to Harvard Medical School (HMS) affiliated hospitals to aid in recruitment, adopting another imaging modality (i.e., fNIRS) that does not have COVID-related restrictions, and exploring adding another research scanning site at one of the other HMS affiliated hospitals.

The use of dietary supplements for mental health among the Saudi population: A cross-sectional survey.

Introduction: Despite limited evidence about the efficacy and safety of dietary supplements (DSs) for improving mental health, people with or without mental disorders often tend to use them, especially during the ongoing COVID-19 pandemic. Previous studies focused on DS use for maintaining or improving overall health; Therefore, this study aimed to assess the prevalence of DSs for mental health among the SA population and to determine the factors that affect their use. Methods: This cross-sectional study was based on an online survey of Saudi Arabian participants between July and August 2021 with an anonymous, self-completed questionnaire distributed using convenience sampling. The questionnaire included queries related to demographic information, DS use assessment, and mental health evaluation using the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder 7-item (GAD-7), questionnaire, and the Insomnia Severity Index (ISI). Results: In total, 443 participants from various regions of Saudi Arabia completed the questionnaire. The prevalence of DS use in the Saudi population was 44%. Vitamin D (28%) and melatonin (20%) were the most commonly reported DSs used for mental health. The odds of DS use were three times higher in responders with previous mental health diagnoses (OR: 2.972; 95% CI: 1.602-5.515). Furthermore, the chances of using DSs almost doubled in patients with sub-threshold and moderate to severe insomnia (OR: 1.930; 95% CI: 1.191-3.126 and OR: 2.485; 95% CI: 1.247-4.954, respectively). Conclusion: Responders diagnosed by a specialist with psychiatric disorders or current insomnia had a higher chance of using DSs. Thus, healthcare providers must provide evidence-based information regarding DSs for mental health improvement and encourage the public to consult healthcare professionals before self-medicating for mental health problems.

Understanding the Mechanisms of Blue Light Exposure on Cognitive Performance

Military personnel often face challenging situations, including being sleep deprived, having to remain focused and undistracted for long periods of time and having to respond quickly and precisely in response to different critical situations. Being able to sustain attention, even when one is sleep deprived, remain positive and calm, and being able to respond quickly, are all of crucial importance to mission success. Blue light exposure seems to be a safe and easily implemented tool to improve attention, increase cognitive functioning and enhance mood. However, the exact mechanism that explains these beneficial effects is currently unknown. Lack of knowledge makes it impossible to provide exact recommendations for how to best use blue light exposure. It is also unclear how quickly after blue light onset measurable changes in the brain are present and how they correlate with subjective and objective changes in alertness, cognitive functioning and mood. The results from this study will provide information on the exact mechanisms that underlie the positive effects of blue light exposure. Answers to these crucial questions will make it considerably easier to provide targeted and informed recommendations for how to best use blue light across a wide variety of settings in order to improve cognitive functioning.

Fatigue Detection/Prediction Using Machine Learning and Wearable Technology

Fatigue is a known contributor to open water accidents, decreased operational efficiency, and poor Warfighter health. Real-time feedback of the Warfighters cognitive state will allow for increased awareness of capabilities/limitations and adaptable decision making based on Warfighter readiness. The Fatigue Detection/Prediction using Machine Learning (ML) and Wearable Technology project aimed to develop a ML algorithm capable of detecting changes in the Parasympathetic Nervous System (PNS) that are indicative of cognitive fatigue using a Commercial Off-The-Shelf (COTS) wrist-worn device. A biometric dataset of 30 participants (including some active duty personnel) performing quantifiable vigilance tasking was collected and annotated with operator performance metrics and cognitive load. Variations of the Mackworth clock, a vigilance task widely used in psychometric studies to quantify cognitive engagement and fatigue, was used to generate quantitative operator performance metrics and discrete cognitive load states. ML models were trained and validated on the annotated biometric dataset to: 1) regress operator task performance accuracies, and 2) classify cognitive load/task difficulty. A trained Convolution Neural Network (CNN) regression model was able to predict Mackworth Clock task performance accuracy to within a mean absolute error of 2.5 percent. Additionally, a separate CNN classifier model achieved binary task-type classification accuracies of 86.5 percent, with different type tasks corresponding to a higher vs. lower cognitive load. The next phase of this Research and Development (R and D) effort will include additional testing events with Navy-relevant tasking (i.e., ship navigation, track management, and other watch standing tasks) with a participant pool of only active duty personnel.

High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury

The purpose of this research is to use high-definition transcranial direct current stimulation (HD-tDCS) to treat neurosensory postconcussive symptoms (PCS) associated with mild traumatic brain injury (mTBI) in US Veterans and Warfighters. A randomized sham-controlled clinical trial will be performed. We will recruit 120 participants ages 18-59 for the study: 80 participants with mTBI to undergo the intervention, and 40 non-TBI healthy subjects to act as an imaging-only control group. The intervention is 10 days of anodal HD-tDCS to the left dorsolateral prefrontal cortex, paired with vision therapy and cognitive training. Magnetic source imaging (MSI), neuropsychological assessment, and neurosensory evaluation, are obtained before and after the intervention, to assess changes in brain function, postconcussive symptom burden, and quality of life. During this reporting period, preliminary data has been generated demontrating improvements in neurosensory function, cognitive control, and brain activation patterns with the intervention.

Mindfulness-Based Attention Training to Bolster Small Team Performance

The overarching aim of this proposal is to develop, deliver, and investigate the efficacy of MBAT-Team (MBAT-T) as a tool to promoteindividual cognitive performance, resilience, interpersonal interactions, and team-level operational performance. The MBAT-T programwill be tested and compared to the standard MBAT for individuals (MBAT-I) and a no-training control group. We hypothesize thatMBAT-T will benefit squads across all 3 key domains: cognitive performance and resilience, interpersonal interactions, and team-leveloperational performance. We have received approval from the University of Miami IRB and HRPO (Army), have secured a site for theproject, and are on track regarding the coordination with the testing sites, research consultants and delivery of the practicum to the trainerswho will be delivering the MBAT program. The creation of the MBAT-Team course materials and trainer materials are near completion,and significant progress has been made on the preparation and development of the neurobehavioral testing battery for the project. Insummary, our timely success reaching our project milestones over this past year leave us well positioned for continued success in theexecution of this project in the coming year(s).

Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC)

Caregiving for individuals with Alzheimers disease and related dementias (ADRD) and Traumatic Brain Injury-related dementia has been associated with increased risk of both psychiatric morbidity and mortality, including higher risks of depression, anxiety, poor quality of life, and even early mortality. Although there are several beneficial interventions for caregivers of persons with AD, interventions that can help build skills to recognize and manage stress as well as enhance compassion in caregivers are urgently needed. The purpose of this study is to evaluate the effectiveness of proposed intervention, Practice of Acceptance, Awareness, and Compassion in Caregiving (PAACC) that integrates mindfulness training with caregiving skills training. Several studies have shown effectiveness of mindfulness in decreasing caregiver burden in caregivers of individuals with cognitive deficits, but most of them did not provide caregiving skills training with mindfulness. Our study hypothesis is that intervention such as PAACC which combines education, skill building, and mindfulness practices will enhance caregiving skills and will reduce caregiver stress as well as increase quality of life of the care recipient. The objective of the study will be accomplished by conducting a randomized control trial to test effectiveness of PAACC and compare it with existing cognitive behavior-based intervention called Resources for Enhancing Alzheimers Caregiver Health (REACH).

Evaluating Impact of Cerebral Contusions on Brain Network Dysfunction and Epileptogenesis Among Patients with Traumatic Brain Injuries

The funding for study EP170034 was granted to LSU Health Sciences Center (LSUHSC (Shreveport on September 15th, 2018. The study protocol was approved by the U.S. Army Medical Research and Materiel Command (USAMRMC), Office of Research Protections (ORP), Human Research Protection Office (HRPO) on June 7th, 2019. Dr. Hai Sun accepted the job offer from Rutgers University. He resigned from LSUHSC effectively on August 31st and began serving as an Associate Professor in the Department of Neurosurgery at RWJMS at Rutgers University (RU) on September 9th, 2019. The DOD and CDMRP granted the permission to transfer the study from LSUHSC to RWJMS at RU. The transfer was completed in March, 2020. Then the COVID-19 pandemic has resulted the suspension of all research effort in March. Currently RU is undergoing Phase 3 reopening and the current regulation still prohibits any research study involving face-to-face interaction with human subjects. EP170034 falls in this category. In the meantime, the IRB committee at RWJMS at RU has approved our study protocol on July 8, 2020. This continuing review of this study protocol was submitted to the USAMRDC, ORP, and HRPO on July 15, 2020. We are waiting for the permission from RU to resume research studies involving face-to-face interaction with human subjects. We have necessary study infrastructure to begin subject recruitment as soon as the permission is granted.

Predicting Situational Onset of Aggression in Minimally Verbal Youth with Autism Using Biosensor Data and Machine Learning Algorithms

Unpredictable aggressive behavior by youth with autism spectrum disorder (ASD) isolates them from educational, social, and family activities. Approximately 2/3 of youth with ASD display aggression, a common reason for treatment referral;yet evidence-based pharmacological and behavioral interventions for aggression in ASD are frequently ineffective. Aggression is particularly impairing in the 30-40% of youth with ASD who are minimally verbal (MV-ASD). Aggression may represent a maladaptive attempt to express or modulate physiological arousal arising from distress. We hypothesize that physiological arousal precedes aggressive behavior. We aim to predict aggression in MV-ASD before it occurs using data collected from wrist-worn physiological sensors and behavior observation. Using sophisticated machine learning algorithms linking observable aggression to preceding physiological signals (heart rate, skin conductance), we may identify new opportunities for intervention. Since project launch, we have refined data collection procedures, established processes for behavioral data upload and physiological data transfer to collaborators at NEU, and implemented physiological data quality checks. Staff training has been completed on all procedures including use of biosensors and a smartphone application to code aggression instances, at a high level of inter-rater reliability. 30 MV-ASD youth have been enrolled and data collection has been completed with 10.