Trial Purpose and Description
All procedures within the current protocol application were previously approved under HIC 1012007791, with the exception of procedures pertaining to physical fitness carried out at the external location ASD Fitness Center: Special Needs Fitness Gym. These ASD Fitness procedures were approved under protocol HIC 1508016307. Procedures merged from the ASD Fitness protocol into the 1012007791 procedures are shown as red within this document.
Our research aims to refine our understanding of atypical development of social cognition and attention associated with Autism Spectrum Disorder (ASD), as well as identifying behavioral and neural markers of ASD, developing experimental therapeutics, reducing the age of detection, and expanding accessibility of screening and treatment to a larger population, and to leverage new technologies to accomplish these goals. We approach these goals through the design and use of innovative technology designed for enhanced detection and intervention, sampling children and adults with autism spectrum disorders (ASD), other developmental delays (DD), and who are typically developing (TD). Methods and technological interfaces including: eye tracking, social robots, mobile technologies, electronic and video games, Near Infrared Spectroscopy (fNIRS), Electrodermal Activity (EDA), Radiant Skin Temperature, behavioral studies, and direct assessments and questionnaires.
Ages: 17 years and younger
Participants younger than 18 years will be included in this study after their parents or legal guardians provide written informed consent. Adult participants will be included after they themselves or their legal guardians have provided written informed consent. Individuals with an autism spectrum disorder (ASD) will be included in the project if they fulfill criteria for autistic disorder or PDD-NOS on the Autism Diagnostic Observation Schedule (ADOS; Lord et al, 2000) and receive a diagnosis of autism or PDD-NOS by experienced clinicians (Drs. Chawarska, and Koller). Individuals with non-autistic developmental delays (DD) will be included in the project if they do not meet criteria for autism or PDD-NOS on the ADOS and the clinicians¿ diagnostic impression and standard assessment instruments indicate for instance, global developmental delay, attentional difficulties, or a language disorder. Typically developing controls (TD) will be included in the project if there is no history of delays or present delays in overall development based on direct developmental assessment with the Mullen Scales of Early Learning as well as history and parent interview.
Participants in the project will be excluded on the basis of any one of the following circumstances: suspected or diagnosed hearing loss or visual impairment, or diagnosed neurological abnormality significantly impacting on visual or auditory acuity. These exclusionary procedures will include review of the file, completion of medical checklist and follow-up interview with caregivers.
Individuals who, based on the Screening Interview, were deemed not eligible for research but whose history and presentation are consistent with the profile of children assessed in our clinic will be offered a clinical evaluation or referred elsewhere for an evaluation.
National Institutes of Health
Start Date: 11/02/2016
End Date: 09/01/2026
Last Updated: 02/22/2018
Study HIC#: 1608018194