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

Status:	Active, not recruiting
Conditions:	Cognitive Studies, Neurology, Autism
Therapuetic Areas:	Neurology, Psychiatry / Psychology
Healthy:	No
Age Range:	Any
Updated:	2/21/2019
Start Date:	February 2015
End Date:	June 2019

Early Identification and Service Linkage for Urban Children With Autism

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.

We will conduct a randomized, comparative effectiveness trial to test a systemic,
lay-delivered FN protocol against conventional care management services. The study will take
place in three integrated primary care networks and their affiliated Developmental and
Behavioral Pediatrics (DBP) clinics at Boston Medical Center, Children's Hospital of
Philadelphia, and Yale University Medical School. We will enroll children with confirmed risk
for ASD in the randomized trial and will employ 1:1 randomization by child. The FN protocol
will include individualized navigation to support completion of the diagnostic evaluation,
referral to appropriate services, and linkage to and engagement in services. We will
determine FN's effect on identifying children at risk for ASD, timing of diagnosis, and
receipt of evidence-based ASD services.

The study seeks to accomplish the following aims:

1. Implement a decision rule for referral for formal ASD evaluation;

2. Ensure timely diagnosis and deployment of services.

If successful, our study will provide real world primary care practices with a replicable
model of care that increases early identification and access to timely diagnostic and early
intervention services for a vulnerable population of urban families.

Children will be followed for 12 months. Data regarding screening outcomes, diagnosis and
service utilization will be abstracted from children's medical records. Measures of parental
stress, self-management skills, caregiver burden, and satisfaction with services will be
administered over 4 collection time points, linked to key intervention outcomes. We will
assess the superiority of FN as compared to CCM as a means to: implement a decision rule for
referral to ASD evaluation; shorten the time to diagnosis among children suspected to have
ASD; shorten the time to deployment of ASD services among those diagnosed; and improve
engagement with ASD services.

Inclusion Criteria:

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

Exclusion Criteria:

- Previous diagnosis of Autism Spectrum Disorder

We found this trial at

sites

Yale University School of Medicine

333 Cedar St
New Haven, Connecticut 06504

(203) 432-4771