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

Study Overview
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Brief Summary
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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
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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: Implement a decision rule for referral for formal ASD evaluation; 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.

Official Title
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Early Identification and Service Linkage for Urban Children With Autism

Conditions
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Autism, Developmental Delay Disorders

Intervention / Treatment
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* Behavioral: Family Navigation
* Behavioral: Conventional Care Management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Months
Maximum Age: 27 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Navigation<br>Families will work one-on-one with the navigator who provides off-site support - e.g. home visits or accompanying families to appointments. The goal of FN during the diagnostic evaluation period is to ensure timely completion of the evaluation. The focus of these interactions is to understand the structure and purpose of the evaluation, gather and complete required materials, and address logistic barriers related to the diagnostic visit. The navigator will continue to work with the family after the diagnostic evaluation to access recommended services and support the family's engagement in treatment. | Behavioral: Family Navigation<br> <br> |
| Active Comparator: Conventional Care Management<br>Families will be assigned to a care manager for the diagnostic evaluation and for 100 days thereafter. Consistent with a high quality medical home, the care manager will be responsible to ensure that the referral for the diagnostic evaluation has been made. She is also available for family-initiated support. The care manager will be responsible for ensuring that referrals are made and continue to provide family-initiated, clinic-based support to families for up to 100 days after the completion of diagnostic evaluation. | Behavioral: Conventional Care Management<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic interval (Number of days defined as beginning the day of the positive confirmatory screen and ending the day when the family receives a determination (yes/no) of ASD diagnosis) | Number of days defined as beginning the day of the positive confirmatory screen and ending the day when the family receives a determination (yes/no) of ASD diagnosis | On average 90 -120 days, specific date is linked to the completion of the developmental assessment | 
| Time to receipt of ASD services/recommended services | Number of days from date of diagnosis to receipt of recommended services | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of ASD diagnosis (based on DSM V criteria made by a Board Certified DBP Pediatrician. Assessments are based on site protocols; all use standardized, validated measures appropriate for very young children.) | Determination of ASD diagnosis will be based on DSM V criteria made by a Board Certified DBP Pediatrician. Assessments are based on site protocols; all use standardized, validated measures appropriate for very young children. | 1 year | 
| Satisfaction with Family Navigator (Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I)) | Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) is a newly validated 9 item scale to assess satisfaction with the interpersonal relationship with the navigator. | 100 days after developmental assessment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorder (ASD), Family navigation