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NCT02359084 · ClinicalTrials.gov registry record · NA
Project EARLY: Engagement, Assessment, Referral, & Linkage for Young Children
A NA study, sponsored by Boston University.
- Completed
- Registry status
- NA
- Development phase
- 340
- Enrollment target
NCT02359084: Completed NA study, sponsored by Boston University.
NCT02359084 is a NA study that has completed, run by Boston University. The registered enrollment target is 340 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02359084, a NA study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- NA
- Development phase
- 340 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- BEHAVIORAL Family Navigation
- BEHAVIORAL Conventional Care Management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2015-02 |
| Est. Completion | 2021-08-25 |
| Phase | NA |
What the finished NCT02359084 record still lists
NCT02359084 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Family Navigation is the first listed.
NCT02359084 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02359084 about?
NCT02359084 is a clinical study titled "Project EARLY: Engagement, Assessment, Referral, & Linkage for Young Children". 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 tha...
What is the current status of trial NCT02359084?
This trial is currently completed. It is a NA study. The enrollment target is 340 participants. The study started on 2015-02. Estimated completion is 2021-08-25.
What interventions are being tested in trial NCT02359084?
The interventions under investigation include: Family Navigation (BEHAVIORAL), Conventional Care Management (BEHAVIORAL).
Who is sponsoring clinical trial NCT02359084?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02359084's enrollment target sits among peer trials
340 302nd of 2000 higher than 1,696 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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