Clinical trial NCT03625115: The Opening Doors to Early Intervention Study
Official title: Reducing Disparities in Early Intervention Use: The Opening Doors to Early Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development Delay
Development, Child
Keywords: Early Intervention
Developmental outcomes
Health disparities
Early Childhood
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-08-10
Enrollment: 357
Sex: ALL
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Evaluation of the Child's Cognitive Functioning (i.e., Sensorimotor Development, Problem Solving Skills)
timeFrame: 12 months
measure: Early Intervention Referral Completion
timeFrame: up to 12 months
measure: Early Intervention Services Initiation
timeFrame: up to 12 months
measure: Evaluation of the Child's Overall Language Functioning (Receptive and Expressive Language Skills and Abilities)
timeFrame: 12 months
Secondary outcomes:
measure: Public Policy Changes
timeFrame: up to 12 months
Other outcomes:
measure: An Evaluation of Parent/Family Engagement in the Early Intervention Process
timeFrame: up to 3 months
measure: Measure of Adversity Experienced in Childhood
timeFrame: up to 12 months
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: James Guevara, MD
role: PRINCIPAL_INVESTIGATOR
References: