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

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.

Study Overview

• Status: Completed
• Conditions: Autism; Developmental Delay Disorders
• Intervention / Treatment: Behavioral: Family Navigation; Behavioral: Conventional Care Management

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.

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School Of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02128
      • East Boston Neighborhood Health Center
    • Boston, Massachusetts, United States, 02118
      • South End Community Health Center
    • Boston, Massachusetts, United States, 02118
      • Boston University School of Public Health
    • Boston, Massachusetts, United States, 02122
      • Dorchester House Multi-Service Center
    • Boston, Massachusetts, United States, 02124
      • Codman Square Health Center
    • Chelsea, Massachusetts, United States, 02150
      • MGH Chelsea
    • Lowell, Massachusetts, United States, 01854
      • Lowell Community Health Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Family Navigation; 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
ACTIVE_COMPARATOR: Conventional Care Management; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale - Self Report	The Perceived STress Scale is a measure of the degree to which situations in one's life are appraised as stressful. The questions in the PSS ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way.; lower scores are more favorable.	1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Parenting Stress Index - Short Form	This measure is a brief version of the Parenting Stress Index, a widely used and well-researched measure of parenting stress. The PSI-SF has 36 items from the original 120-item PSI. Items are identical to those in the original version. It was developed in response to clinicians' and researchers' need for a shorter measure of parenting stress and was based on Castaldi's factor analysis of the original PSI, which suggested the presence of three factors. It yields scores on the following subscales: 1) Parental Distress, 2) Parent-Child Dysfunctional Interaction, and 3) Difficult Child. Similar to the full PSI, it also has a validity scale.	1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Brief COPE		1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Pearlin Mastery Scale	The Pearlin Mastery Scale is designed to measure self-concept and references the extent to which individuals perceive themselves in control of forces that significantly impact their lives. Total score can range from 7 to 28 points; higher scores are more favorable.	1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
VR12 Health Survey	VR-12 includes 12 original question items from the VR-36. The questions in this survey correspond to seven different health domains: general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health.	1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
MOS-Social Support Survey	This is a brief, multidimensional, self-administered, social support survey that was developed for patients in the Medical Outcomes Study (MOS), a two-year study of patients with chronic conditions. This survey was designed to be comprehensive in terms of recent thinking about the various dimensions of social support.	1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Family Impact Questionnaire		1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Autism Parenting Stress Index (APSI)	Screening and triage measure for evaluating the parenting system and identifying issues that may lead to problems in the child's or parent's behavior. Focuses on three major domains of stress: child characteristics, parent characteristics and situational/demographic life stress.	1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Adaptive Behavior Assessment System	Communication, Social, and Self-Direction subscales	1 year after failed confirmatory screen
Brief Illness Perception Questionnaire		1 year after failed confirmatory screen
Hospital Care Questionnaire		100 days after developmental assessment completion, 1 year after failed confirmatory screen
Engagement in treatment	Number of hours of ASD/general developmental services	1 year
Mullen Scales of Early Learning (MSEL)	Visual Reception, Fine Motor, Receptive Language, and Expressive Language scales	1 year after failed confirmatory screen
Vineland Adaptive Behavior Scales-3	Parent/caregiver rating form; all domains except motor and maladaptive	1 year after failed confirmatory screen
Autism Diagnostic Observation Schedule-2		at time of evaluation and 1 year after failed confirmatory screen

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Institute of Mental Health (NIMH); Children's Hospital of Philadelphia; Yale University; Developmental Behavioral Pediatrics Research Network
• Investigators: Principal Investigator: Emily Feinberg, ScD, Boston University

Publications and helpful links

General Publications

• Eilenberg JS, Kizildag D, Blakey AO, Cardona ND, Oberoi A, Broder-Fingert S, Feinberg E, Long KA. Implications of Universal Autism Screening: Perspectives From Culturally Diverse Families With False-Positive Screens. Acad Pediatr. 2022 Mar;22(2):279-288. doi: 10.1016/j.acap.2021.12.025. Epub 2021 Dec 25.
• Feinberg E, Augustyn M, Broder-Fingert S, Bennett A, Weitzman C, Kuhn J, Hickey E, Chu A, Levinson J, Sandler Eilenberg J, Silverstein M, Cabral HJ, Patts G, Diaz-Linhart Y, Fernandez-Pastrana I, Rosenberg J, Miller JS, Guevara JP, Fenick AM, Blum NJ. Effect of Family Navigation on Diagnostic Ascertainment Among Children at Risk for Autism: A Randomized Clinical Trial From DBPNet. JAMA Pediatr. 2021 Mar 1;175(3):243-250. doi: 10.1001/jamapediatrics.2020.5218. Erratum In: JAMA Pediatr. 2021 May 1;175(5):538.
• Broder-Fingert S, Walls M, Augustyn M, Beidas R, Mandell D, Wiltsey-Stirman S, Silverstein M, Feinberg E. A hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder. BMC Psychiatry. 2018 Mar 27;18(1):79. doi: 10.1186/s12888-018-1661-7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2015
• Primary Completion (ACTUAL): August 25, 2021
• Study Completion (ACTUAL): August 25, 2021

Study Registration Dates

• First Submitted: February 1, 2015
• First Submitted That Met QC Criteria: February 4, 2015
• First Posted (ESTIMATE): February 9, 2015

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Autism Spectrum Disorder (ASD); Family navigation
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder; Developmental Disabilities
• Other Study ID Numbers: H-33008; 1R01MH104355 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared with the National Database for Autism Research biannually.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No