Project EARLY: Engagement, Assessment, Referral, & Linkage for Young Children
Condition: Autism; Developmental Delay Disorders
MeSH terms: Autistic Disorder; Developmental Disabilities
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Family Navigation; Conventional Care Management
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Autism Spectrum Disorder (ASD); Family navigation