The Opening Doors to Early Intervention Study

NCT03625115 | Completed Results DMC

• 2 other identifiers: 18-014807R01MD011598
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 1

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.

Conditions

Development Delay; Development, Child

Keywords

Early Intervention; Developmental outcomes; Health disparities; Early Childhood

Outcome Measures

Primary Outcomes (4)

• 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

• Early Intervention Referral Completion

  Completion of early intervention referrals defined as completing a multidisciplinary assessment (MDE).

  up to 12 months

• Early Intervention Services Initiation

  Initiation of early intervention services if deemed eligible for services, defined as participants who started services.

  up to 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

Secondary Outcomes (1)

• Public Policy Changes

  up to 12 months

Other Outcomes (2)

• An Evaluation of Parent/Family Engagement in the Early Intervention Process

  up to 3 months

• Measure of Adversity Experienced in Childhood

  up to 12 months

Study Arms (2)

Usual Care (Control)

NO INTERVENTION

Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.

Family Navigator (Intervention)

EXPERIMENTAL

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)

Interventions

Family Navigator (FN) BEHAVIORAL

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.

Family Navigator (Intervention)

Eligibility Criteria

• Age: Up to 29 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. James Guevara
• Organization: Children's Hospital of Philadelphia

guevara@chop.edu

2155901130

Study Officials

• James Guevara, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research staff collecting study data will be unaware of study arm of participants.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 10, 2018
• Study Start: September 11, 2018
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 12 months after the end of the final year of funding.

Locations

US (1)