A platform trial approach to proof-of-concept (POC) studies in autism spectrum disorder: Autism spectrum POC initiative (ASPI).

Background: Over the past decade, autism spectrum disorder (ASD) research has blossomed, and multiple clinical trials have tested potential interventions, with varying results and no clear demonstration of efficacy. Lack of clarity concerning appropriate biological mechanisms to target and lack of sensitive, objective tools to identify subgroups and measure symptom changes have hampered the efforts to develop treatments. A platform trial for proof-of-concept studies in ASD could help address these issues.

Context Modulates Attention to Faces in Dynamic Social Scenes in Children and Adults with Autism Spectrum Disorder.

Individuals with autism spectrum disorder (ASD) have been found to view social scenes differently compared to typically developing (TD) peers, but results can vary depending on context and age. We used eye-tracking in children and adults (age 6-63) to assess allocation of visual attention in a dynamic social orientation paradigm previously used only in younger children. The ASD group (n = 94) looked less at the actor's face compared to TD (n = 38) when they were engaged in activity (mean percentage of looking time, ASD = 30.

Current Approaches to the Pharmacologic Treatment of Core Symptoms Across the Lifespan of Autism Spectrum Disorder.

There are no approved medications for autism spectrum disorder (ASD) core symptoms. However, given the significant clinical need, children and adults with ASD are prescribed medication off label for core or associated conditions, sometimes based on limited evidence for effectiveness. Recent developments in the understanding of biologic basis of ASD have led to novel targets with potential to impact core symptoms, and several clinical trials are underway.

Visual Preference for Biological Motion in Children and Adults with Autism Spectrum Disorder: An Eye-Tracking Study.

Participants with autism spectrum disorder (ASD) (n = 121, mean [SD] age: 14.6 [8.0] years) and typically developing (TD) controls (n = 40, 16.

Learning Scan Paths of Eye Movement in Autism Spectrum Disorder.

Eye tracking studies have demonstrated deficits in attention in individuals with Autism Spectrum Disorder (ASD) for a range of different social attention-based tasks. Here we examined social attention skills in a large sample of ASD participants (n = 120), using eye tracking data from a social information processing task, and compared them with a typically developing (TD) group (n = 35). Assuming eye movement parameters are random variables generated by an underlying stochastic process, we modeled the fixation sequences of participants in ASD and TD groups with a Hidden Markov Model.

Publisher Correction: ASPI: a public-private partnership to develop treatments for autism.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Automated recognition of spontaneous facial expression in individuals with autism spectrum disorder: parsing response variability.

Background: Reduction or differences in facial expression are a core diagnostic feature of autism spectrum disorder (ASD), yet evidence regarding the extent of this discrepancy is limited and inconsistent. Use of automated facial expression detection technology enables accurate and efficient tracking of facial expressions that has potential to identify individual response differences.

Methods: Children and adults with ASD (N = 124) and typically developing (TD, N = 41) were shown short clips of "funny videos.

Relationship Between Sleep and Behavior in Autism Spectrum Disorder: Exploring the Impact of Sleep Variability.

Objective: The relationship between sleep (caregiver-reported and actigraphy-measured) and other caregiver-reported behaviors in children and adults with autism spectrum disorder (ASD) was examined, including the use of machine learning to identify sleep variables important in predicting anxiety in ASD.

Methods: Caregivers of ASD ( = 144) and typically developing (TD) ( = 41) participants reported on sleep and other behaviors. ASD participants wore an actigraphy device at nighttime during an 8 or 10-week non-interventional study.

Current Approaches to the Pharmacologic Treatment of Core Symptoms Across the Lifespan of Autism Spectrum Disorder.

There are no approved medications for autism spectrum disorder (ASD) core symptoms. However, given the significant clinical need, children and adults with ASD are prescribed medication off label for core or associated conditions, sometimes based on limited evidence for effectiveness. Recent developments in the understanding of biologic basis of ASD have led to novel targets with potential to impact core symptoms, and several clinical trials are underway.

Caregiver Daily Reporting of Symptoms in Autism Spectrum Disorder: Observational Study Using Web and Mobile Apps.

Background: Currently, no medications are approved to treat core symptoms of autism spectrum disorder (ASD). One barrier to ASD medication development is the lack of validated outcome measures able to detect symptom change. Current ASD interventions are often evaluated using retrospective caregiver reports that describe general clinical presentation but often require recall of specific behaviors weeks after they occur, potentially reducing accuracy of the ratings.

Clinical Validation of the Autism Behavior Inventory: Caregiver-Rated Assessment of Core and Associated Symptoms of Autism Spectrum Disorder.

There is a need for measures to track symptom change in autism spectrum disorder (ASD). We conducted a validation study on a revised version of the Autism Behavior Inventory (ABI), and a short form (ABI-S). Caregivers of individuals (6-54 years) with confirmed diagnoses of ASD (N = 144) completed the ABI and other rating scales at 4 time points.

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

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. An observational, non-interventional, prospective study of JAKE in children and adults with ASD was conducted at nine sites in the United States.

Automatic Recognition of Posed Facial Expression of Emotion in Individuals with Autism Spectrum Disorder.

Facial expression is impaired in autism spectrum disorder (ASD), but rarely systematically studied. We focus on the ability of individuals with ASD to produce facial expressions of emotions in response to a verbal prompt. We used the Janssen Autism Knowledge Engine (JAKE), including automated facial expression analysis software (FACET) to measure facial expressions in individuals with ASD (n = 144) and a typically developing (TD) comparison group (n = 41).

Visual Exploration in Autism Spectrum Disorder: Exploring Age Differences and Dynamic Features Using Recurrence Quantification Analysis.

Eye-tracking studies have demonstrated that individuals with autism spectrum disorder sometimes show differences in attention and gaze patterns. This includes preference for certain nonsocial objects, heightened attention to detail, and more difficulty with attention shifting and disengagement, which may be associated with restricted and repetitive behaviors. This study utilized a visual exploration task and replicates findings of reduced number of objects explored and increased fixation duration on high autism interest objects in a large sample of individuals with autism spectrum disorder (n = 129, age 6-54 years) in comparison with a typically developing group.

JAKE® Multimodal Data Capture System: Insights from an Observational Study of Autism Spectrum Disorder.

To test usability and optimize the Janssen Autism Knowledge Engine (JAKE®) system's components, biosensors, and procedures used for objective measurement of core and associated symptoms of autism spectrum disorder (ASD) in clinical trials. A prospective, observational study of 29 children and adolescents with ASD using the JAKE system was conducted at three sites in the United States. This study was designed to establish the feasibility of the JAKE system and to learn practical aspects of its implementation.

Automated Detection of Stereotypical Motor Movements in Autism Spectrum Disorder Using Recurrence Quantification Analysis.

A number of recent studies using accelerometer features as input to machine learning classifiers show promising results for automatically detecting stereotypical motor movements (SMM) in individuals with Autism Spectrum Disorder (ASD). However, replicating these results across different types of accelerometers and their position on the body still remains a challenge. We introduce a new set of features in this domain based on recurrence plot and quantification analyses that are orientation invariant and able to capture non-linear dynamics of SMM.