title: Identification of neurodevelopmental disabilities in underserved children using telehealth (INvesT): Clinical trial study design.
abstract: BACKGROUND
  Children living in poverty are at high risk for delays in development of language and behavior and they experience a discrepancy in diagnosis and access to intervention services. This gap is partially caused by barriers in access as well as traits that are specific to each child and family. The Identification of Neurodevelopmental Disabilities in Underserved Children using Telehealth (INvesT) trial is a novel intervention approach that was specifically designed to address these barriers.
  
  
  OBJECTIVE
  The INvesT trial has three primary aims: 1) to reduce the age of identification of neurodevelopmental disability for high-risk, low-income children. 2) To validate the INvesT protocol as a service delivery model that will decrease age of identifications of neurodevelopmental disability for high-risk, low-income children; and 3) to identify important child-specific factors, family-specific factors, and environmental factors that impact feasibility and success of the INvesT trial for high-risk, low-income children.
  
  
  METHODS
  The INvesT trial is an open-label, double-blinded, placebo-controlled multi-level study that includes telehealth risk assessment, telehealth screening, traditional full assessment, and follow through to enrollment in early intervention. The trial is conducted in partnership with an urban community health clinic that largely serves a low-income patient population.
  
  
  CONCLUSIONS
  The results of the INvesT trial will provide evidence for the use of a telehealth service delivery model to improve access to care for neurodevelopmental disabilities for high-risk, low-income children.
authors.affiliation: Department of Psychological Sciences, Case Western Reserve University, 11635 Euclid Ave., Cleveland, OH, USA. Electronic address: angela.ciccia@case.edu.
authors.forename: Angela Hein
authors.initials: AH
authors.lastname: Ciccia
authors.affiliation: Department of Behavioral Pediatrics, Case Medical Center, Rainbow Babies and Children's Hospital, 10524 Euclid Ave., Ste. 3150, Cleveland, OH, USA. Electronic address: nancy.roizen@uhhospitals.org.
authors.forename: Nancy
authors.initials: N
authors.lastname: Roizen
authors.affiliation: Division of Information Technology Services, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, USA. Electronic address: mxg77@case.edu.
authors.forename: Matt
authors.initials: M
authors.lastname: Garvey
authors.affiliation: Division of Information Technology Services, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, USA; Department of Epidemiology & Biostatistics, Case Western Reserve University, 10900 Euclid Ave., Cleveland, OH, USA. Electronic address: roger.bielefeld@case.edu.
authors.forename: Roger
authors.initials: R
authors.lastname: Bielefeld
authors.affiliation: Department of Psychological Sciences, Case Western Reserve University, 11635 Euclid Ave., Cleveland, OH, USA. Electronic address: elizabeth.short@case.edu.
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Short
mesh_terms: D002675:Child, Preschool; D003153:Community Health Services / Q000458:organization & administration*; D002658:Developmental Disabilities / Q000175:diagnosis* / Q000453:epidemiology*; D004311:Double-Blind Method; D018479:Early Intervention, Educational; D004777:Environment; D005190:Family; D006297:Health Services Accessibility; D006801:Humans; D007223:Infant; D007802:Language; D008603:Mental Health; D011203:Poverty; D012107:Research Design; D017216:Telemedicine / Q000379:methods*
keywords: Clinical trial; Developmental surveillance; Neurodevelopmental disability; Pediatrics; Telehealth