A hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder

BMC Psychiatry. 2018 Mar 27;18(1):79. doi: 10.1186/s12888-018-1661-7.


Background: Significant racial, ethnic, and socioeconomic disparities exist in access to evidence-based treatment services for children with autism spectrum disorder (ASD). Patient Navigation (PN) is a theory-based care management strategy designed to reduce disparities in access to care. The purpose of this study is to test the effectiveness of PN a strategy to reduce disparities in access to evidence-based services for vulnerable children with ASD, as well as to explore factors that impact implementation.

Methods: This study uses a hybrid type I randomized effectiveness/implementation design to test effectiveness and collect data on implementation concurrently. It is a two-arm comparative effectiveness trial with a target of 125 participants per arm. Participants are families of children age 15-27 months who receive a positive screen for ASD at a primary care visit at urban clinics in Massachusetts (n = 6 clinics), Connecticut (n = 1), and Pennsylvania (n = 2). The trial measures diagnostic interval (number of days from positive screen to diagnostic determination) and time to receipt of evidence-based ASD services/recommended services (number of days from date of diagnosis to receipt of services) in those with PN compared to and activated control -Conventional Care Management - which is similar to care management received in a high quality medical home. At the same time, a mixed-method implementation evaluation is being carried out.

Discussion: This study will examine the effectiveness of PN to reduce the time to and receipt of evidence-based services for vulnerable children with ASD, as well as factors that influence implementation. Findings will tell us both if PN is an effective approach for improving access to evidence-based care for children with ASD, and inform future strategies for dissemination.

Trial registration: NCT02359084 Registered February 1, 2015.

Keywords: Autism spectrum disorder; Disparities; Navigation.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Autism Spectrum Disorder / therapy*
  • Child
  • Child, Preschool
  • Comparative Effectiveness Research
  • Connecticut
  • Ethnicity
  • Female
  • Health Services Accessibility / statistics & numerical data*
  • Healthcare Disparities / statistics & numerical data*
  • Humans
  • Male
  • Massachusetts
  • Patient Navigation / methods*
  • Pennsylvania
  • Primary Health Care / methods*
  • Research Design

Associated data

  • ClinicalTrials.gov/NCT02359084