CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 357 enrolled
Drug / intervention
Family Navigator (FN)behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03625115
NCT03625115N/ACompleted

Reducing Disparities in Early Intervention Use: The Opening Doors to Early Intervention Study

Children's Hospital of Philadelphia·interventional·Posted Aug 10, 2018·Updated Feb 10, 2025

In Brief

A clinical study evaluating Family Navigator (FN) for Development Delay and Development, Child. Completed, enrolled 357 participants across 1 site.

Detailed Summary

Poor urban minority children often experience delays in their early development leading to health disparities. Publicly funded early intervention services are available to improve child development among these children in Philadelphia, but few children access and complete these services. This can be due to parents misunderstanding what the services include or may be due to difficulties parents experience in overcoming barriers to participating. This study will test the effectiveness of the Opening Doors to Early Intervention Program, a patient navigation intervention designed to improve families' engagement with early intervention services and overcome barriers to access these services, on early child development.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 10, 2018
Enrollment StartSep 11, 2018
Primary CompletionSep 25, 2023
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 7.9 years ago

Interventions

Family Navigator (FN)behavioral

The intervention will be a modified Patient Navigator model, that we will refer to as a Family Navigator (FN) model, that will engage, inform, and assist participating parents to follow-through with the process of EI referrals and services. Eligible children randomized to the intervention arm will be provided with services from a FN. The FN will maintain contact with the family, the child's primary care provider, and Early Intervention staff, if applicable, throughout the duration of the study.