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

Data will be shared with the National Database for Autism Research biannually.