The Opening Doors to Early Intervention Study

Developmental delays are frequently encountered among young children and disproportionately
affect impoverished minority children leading to disparities in early child development. To
promote healthy child development, the Individuals with Disabilities Education Act (IDEA)
mandated early intervention (EI) services be made available to young children with delays,
but only half of at-risk children initiate and complete EI services. As a result, many
at-risk children may not receive needed services to improve their development. To foster
initiation and completion of EI services, Investigators developed the Opening Doors to Early
Intervention Program, a patient navigation intervention based on the Health Belief Model and
targeted to at-risk urban minority children. An initial pilot study among at-risk children
demonstrated feasibility and generated promising results. Therefore, this Community-Based
Participatory Research application proposes to test the effectiveness of this program in a
single urban county using a randomized trial design. The specific aims are to 1) determine
the effectiveness of the Opening Doors to early Intervention Program on child developmental
status and EI referral and services use, 2) assess whether parent engagement in early
intervention mediates the effects of the program, and 3) explore whether the home learning
environment, parental health literacy, and poverty moderate the effects of the program. This
application addresses health disparities in early childhood by testing an intervention
designed to improve participation rates in EI among urban minority children and their
families on measures of early child development and EI services use. Three to four primary
care pediatric clinics that provide care to this diverse urban community will be recruited to
participate. Three hundred sixty children who are less than 30 months of age and have been
identified as developmentally at-risk and referred for EI services at participating clinics
will be randomized to receive the Opening Doors to Early Intervention Program or usual care.
Urban minority parents who have previously participated in EI services will be trained as
patient navigators to provide education, motivation, and assistance for families with
initiation and completion of EI referrals and services. Clinicians and Child Find staff will
provide usual care consisting of developmental screening and referrals without assistance.
Information on participant demographic characteristics, health literacy, and the home
learning environment at baseline; parent engagement and EI referral and services completion
at 3, 6, 9, and 12 months; and child development at 12 months will be collected during
scheduled study visits. Differences in outcomes between intervention and control participants
will be compared using intention-to-treat analysis. Findings from this comparative
effectiveness study can be disseminated to similar large urban counties across the U.S. to
inform Child Find and EI procedures and address disparities in early child development.

Inclusion Criteria:

- Child is <30 months old at time of enrollment

- Child was born >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 within the past 30 days to the Philadelphia Infant
Toddler Early Intervention Program in Philadelphia County

Exclusion Criteria:

- Child moves outside of Philadelphia County

- Child has previously received EI services

- Child has congenital anomalies, genetic syndromes, or human immunodeficiency virus
(HIV)