Project EARLY: Engagement, Assessment, Referral, & Linkage for Young Children

Summary

Emerging evidence demonstrates that Autism Spectrum Disorder (ASD) can be reliably diagnosed by age two, and that early identification and intervention can improve outcomes. Low-income and minority children with ASD, however, are diagnosed later and experience greater delays in service provision than their white and more financially advantaged peers. Feasible, culturally appropriate interventions with broad scale-up potential are necessary to reduce this disparity. This project builds upon pilot studies of an adapted version of Patient Navigation, as means to reduce disparities in ASD diagnosis and service provision. Patient Navigation is a lay-delivered case management approach that focuses on overcoming logistical hurdles to care during a defined episode.

This project has 2 components, both of which take place in urban, integrated care networks that provide healthcare to low-income children. This registration is for the clinical trial component of the study. The project is a multisite, randomized comparative effectiveness trial of a systemic, lay-delivered adaptation of Patient Navigation, referred to as Family Navigation (FN), which begins with a failed autism screen and ends 100 days after an ASD diagnosis is made. The basic structure of both intervention arms is a collaborative care system. The conventional care management arm (CCM) is consistent with the type of care provided within a traditional - but high quality - medical home. The FN arm provides more intensive, individually tailored, care coordination and theory-based family support.

Conditions

• Autism
• Developmental Delay Disorders

Interventions

BEHAVIORAL

Family Navigation

BEHAVIORAL

Conventional Care Management

Sponsors & Collaborators

• Yale University

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Developmental Behavioral Pediatrics Research Network

  collaborator UNKNOWN

• Boston University

  lead OTHER

Principal Investigators

• Emily Feinberg, ScD · Boston University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

15 Months

Max Age

27 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2021-08-25

Completion

2021-08-25

Countries

• United States

Study Locations