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

Completed · Not applicable

Conditions studied: Autism, Developmental Delay Disorders

In brief

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.

Key facts

Study ID

NCT02359084

Run by

Boston University

People needed

340

Starts

2015-02-01

Expected to finish

2021-08-25

Last updated by the study team

2022-01-03

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children ages 15 - 27 months at a participating clinic who fail the M-CHAT screen and/or primary care provider has concerns about autism

You may not qualify if…

• Previous diagnosis of Autism Spectrum Disorder

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Boston University School of Public Health — Boston, Massachusetts, United States
• South End Community Health Center — Boston, Massachusetts, United States
• Dorchester House Multi-Service Center — Boston, Massachusetts, United States
• Codman Square Health Center — Boston, Massachusetts, United States
• East Boston Neighborhood Health Center — Boston, Massachusetts, United States
• MGH Chelsea — Chelsea, Massachusetts, United States
• Lowell Community Health Center — Lowell, Massachusetts, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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