NCT02359084|CompletedDMC
Project EARLY: Engagement, Assessment, Referral, & Linkage for Young Children
Early Identification and Service Linkage for Urban Children With Autism
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Early Identification and Service Linkage for Urban Children With Autism
Sponsor study identifier
Secondary identifiers
NIH
interventional
340
1 country
10
Study Start
February 2015
Actual (reported)Primary Completion
August 25, 2021
Actual (reported)Study Completion
August 25, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 25, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2015
Actual (reported)February 1, 2015
Actual (reported)February 9, 2015
Actual (reported)August 25, 2021
Actual (reported)August 25, 2021
Actual (reported)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
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.)
1 year
Satisfaction with Family Navigator (Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I))
100 days after developmental assessment completion
Perceived Stress Scale - Self Report
1-4 weeks after developmental assessment completion, 100 days after developmental assessment completion, 1 year after failed confirmatory screen
Parenting Stress Index - Short Form
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Boston University School of Public Health
Boston, Massachusetts, 02118, United States
South End Community Health Center
Boston, Massachusetts, 02118, United States
Dorchester House Multi-Service Center
Boston, Massachusetts, 02122, United States
Codman Square Health Center
Boston, Massachusetts, 02124, United States
East Boston Neighborhood Health Center
Stransky ML, Kuhn J, Feinberg E. Agreement Between Parental Reports of Part C Early Intervention Service Utilization and Part C Early Intervention Service Records. Child Youth Care Forum. 2024 Aug;53(4):825-847. doi: 10.1007/s10566-023-09773-6. Epub 2023 Nov 2.
Levinson J, Hickey E, Fuchu P, Chu A, Barnett M, Stadnick NA, Feinberg E, Broder-Fingert S. Recommendations for post-implementation adaptations to optimize family navigation in pediatric primary care: a qualitative study with parents and navigators. BMC Prim Care. 2023 Jun 16;24(1):123. doi: 10.1186/s12875-023-02072-y.
Emily Feinberg, ScD
Boston University
340 participants (actual enrollment reported by the registry).
First Submitted
February 1, 2015
First Posted
February 9, 2015
Study Start
February 2015
Actual (reported)Combined Effects of Early Behavioral Intervention and Propranolol on ASD
Contact the study team to confirm eligibility.
Boston, Massachusetts, 02128, United States
MGH Chelsea
Chelsea, Massachusetts, 02150, United States
Lowell Community Health Center
Lowell, Massachusetts, 01854, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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.
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.
Primary Completion
August 25, 2021
Actual (reported)Study Completion
August 25, 2021
Actual (reported)Last Updated
January 3, 2022
Record last verified: 2021-12
Data will be shared with the National Database for Autism Research biannually.
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Source: ClinicalTrials.gov.
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