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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 is a NA study that has completed, run by Boston University. The registered enrollment target is 340 participants.

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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.

Interventions

  • BEHAVIORAL Family Navigation
  • BEHAVIORAL Conventional Care Management

Trial Details

FieldValue
Enrollment Target 340 participants
Start Date 2015-02
Est. Completion 2021-08-25
Phase NA

Sponsor

Boston University

185 total trials

What the Registry Record Tells You About NCT02359084

The ClinicalTrials.gov registry entry for NCT02359084 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Family Navigation is the first listed.

NCT02359084 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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