N/A
N=357
The Opening Doors to Early Intervention Study
Development Delay · Development, Child
Bottom Line
View on ClinicalTrials.gov: NCT03625115 ↗Enrolled (actual)
357
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Evaluation of the Child's Cognitive Functioning (i.e., Sensorimotor Development, Problem Solving Skills) — 83.50; 81.94 score on a scale — p=0.30
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Family Navigator (FN) (Behavioral)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of the Child's Cognitive Functioning (i.e., Sensorimotor Development, Problem Solving Skills) |
83.50; 81.94 | 0.30 |
| PRIMARY Early Intervention Referral Completion |
114; 143; 56; 34 | .004 sig |
| PRIMARY Early Intervention Services Initiation |
88; 107; 5; 7 | .82 |
| PRIMARY Evaluation of the Child's Overall Language Functioning (Receptive and Expressive Language Skills and Abilities) |
79.39; 78.71 | 0.69 |
| SECONDARY Public Policy Changes |
60; 65; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Child is 35 weeks estimated gestational age
- Parent-child dyad reside in Philadelphia and present at a Children's Hospital of Philadelphia (CHOP) primary care practice located in Philadelphia
- Parents are English or Spanish speaking
- Child has recently been referred to the Philadelphia Infant Toddler Early Intervention Program in Philadelphia County
Exclusion Criteria
- Child moves outside of Philadelphia County
- Child has received EI services in the past 2 weeks
- Child has congenital anomalies, genetic syndromes, or human immunodeficiency virus (HIV) that place them at risk of developmental delays
Data sourced from ClinicalTrials.gov (NCT03625115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.