The Opening Doors to Early Intervention Study (ODEI)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Development Delay; Development, Child
• Intervention / Treatment: Behavioral: Family Navigator (FN)

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.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care (Control); Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.
Experimental: Family Navigator (Intervention); Dyads randomized to the Intervention arm with be assigned a designated Family Navigator (FN) who will engage, inform, and assist the participating parents to follow-through with the process of EI referrals and services.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the child's Cognitive functioning (i.e., sensorimotor development, problem solving skills)	The Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is a validated assessment of infant and toddler development for use with 1-42 month olds. The Cognitive domain consists of developmental play tasks that are administered to obtain a developmental quotient in order to determine the child's level of cognitive functioning. The composite score of the Cognitive domain is derived from a single scaled test score from the Cognitive Scale (as opposed to being comprised of the summation of scaled scores from multiple subscales, such as with the BSID-III Language and Motor composite scores). The total composite score may range from 40 to 160. Higher values denote stronger skills and abilities in the domain, indicating better outcomes. Composite scores are scaled to a mean of 100 and a standard deviation of 15.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the child's overall Motor functioning (Fine Motor and Gross Motor skills)	BSID-III motor functioning scale will be used to assess Fine Motor and Gross Motor skills such as manipulating small objects, stacking blocks, sitting, walking, and climbing stairs. The composite score of the Motor functioning domain is composed of the sum of both the Fine Motor and Gross Motor subscales' scaled scores.The total Motor composite score may range from 40 to 160. Higher values denote stronger skills and abilities in the domain, indicating better outcomes. Composite scores are scaled to a mean of 100 and a standard deviation of 15.	12 months
Evaluation of the child's overall Language functioning (Receptive and Expressive Language skills and abilities)	The BSID-III language scale will be used to assess both the understanding of language (receptive language) and use or expression of language (expressive language) skills, such as following simple directions, and naming or identifying objects and pictures. The total composite score of the Language functioning domain is composed of the sum of both the Receptive Language and the Expressive Language subscales' scaled scores. The total Language composite score may range from 40 to 160. Higher values denote stronger skills and abilities in the domain, indicating better outcomes. Composite scores are scaled to a mean of 100 and a standard deviation of 15.	12 months
Evaluation of the child's Social-Emotional functioning (i.e. self regulation, emotional skills)	The BSID-III social-emotional functioning scale is a parent-report measure in the format of a questionnaire. This scale will be used to assess the parent's report about the child's behaviors related to ease of calming, social responsiveness, imitation play, and adaptive behaviors. The total Social-Emotional composite score may range from 40 to 160. Higher values denote stronger skills and abilities in the domain, indicating better outcomes. Composite scores are scaled to a mean of 100 and a standard deviation of 15.	12 months
Early Intervention Referral Completion	Completion of early intervention referrals.	up to 12 months
Early Intervention Services Completion	Completion of early intervention services if deemed eligible for services.	up to 12 months
Public Policy Changes	Changes in state policy regarding early intervention services.	up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
An evaluation of Parent/Family Engagement in the Early Intervention process	Evaluation of the parent(s) and/or family's engagement, or perceived extent of involvement, in the early intervention process. A modified and adapted version of the Client Engagement in Child Protective Services (CECPS) questionnaire, a validated measure of family engagement in child welfare services, will be used to assess parent/family engagement.	up to 12 months
Measure of adversity experienced in childhood	Self-report measure of adverse childhood events	up to 12 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2018
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Early Intervention; Health disparities; Early Childhood; Developmental outcomes
• Other Study ID Numbers: 18-014807; R01MD011598 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A complete, cleaned, and de-identified dataset will be made available to other investigators after all analyses have been conducted and within twelve months of the end of the final year of funding to allow for publication of all study aims. To obtain this data set, other investigators will need to contact the study Principal Investigator (PI) who will provide a data sharing agreement. The data sharing agreement will permit a deidentified data set to be shared once an Institutional Review Board (IRB) protocol has been approved at the investigators' home institution and the investigators have signed a pledge to not attempt to identify individual study subjects. The data set will be made available on a Compact Disc Read-Only Memory (CD-ROM) or through a secure File Transfer Protocol (FTP) site.
• IPD Sharing Time Frame: 12 months after the end of the final year of funding.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No