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The Opening Doors to Early Intervention Study

NCT03625115 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2025-02-10

Study results available
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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.

Conditions

  • Development Delay
  • Development, Child

Interventions

BEHAVIORAL

Family Navigator (FN)

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.

Sponsors & Collaborators

Principal Investigators

  • James Guevara, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
29 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-11
Primary Completion
2023-09-25
Completion
2023-09-25

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03625115 on ClinicalTrials.gov