An interventional study of Family Navigator (FN) in Development Delay and Development, Child, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged Up to 29 Months. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Health services research
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.
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.
150 studies on the registry are indexed under Learning Disabilities; 51 are open to participants now.
This study's enrollment of 357 is above the median of 60 across 101 interventional studies indexed under Learning Disabilities.
Browse Learning Disabilities studies →Children's Hospital of Philadelphia is the lead sponsor of 488 studies on the registry; 91 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Dyads randomized into this control arm will continue with usual care consisting of information about early intervention services and routine Child Find procedures.
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.
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.
Time frame: 12 months
Early Intervention Referral Completion
Completion of early intervention referrals defined as completing a multidisciplinary assessment (MDE).
Time frame: up to 12 months
Early Intervention Services Initiation
Initiation of early intervention services if deemed eligible for services, defined as participants who started services.
Time frame: 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.
Time frame: 12 months
Public Policy Changes
Changes in state policy regarding early intervention services. During the time of the study, the COVID-19 pandemic began, which affected early intervention services and policies. This timeline is broken down into the following time periods. Period 1-Early Intervention in person pre pandemic: Study start date - March 19th, 2020 Period 2-Early Intervention complete closure: March 20th, 2020 - early April 2020 Period 3: Early Intervention Virtual Only: early April 2020 - June 2nd, 2020 Period 4: Early Intervention Hybrid: June 3rd, 2020 - current (in line with Governor Wolf's process to reopen plan, this was when services and evaluations were done both virtually and in person)
Time frame: up to 12 months
An Evaluation of Parent/Family Engagement in the Early Intervention Process
Scale Name: Parent Early Intervention (EI) Engagement Questionnaire Description: Modified and validated version of the Client Engagement in Child Protective Services (CECPS) questionnaire which evaluates the caregiver(s) perceived extent of involvement, in the early intervention process. Scale Ranges: 9 items, split up in to 3 factors/categories, are scored on a likert scale from 1-5. Two items are reverse scored during analysis. 1 indicates poor engagement (poor outcome) and 5 indicates high engagement (high outcome). Each item can be scored 1-5. When items are analyzed by factor/category, the average is taken from all items in that factor/category (can be anywhere in the range of 1-5).
Time frame: up to 3 months
Measure of Adversity Experienced in Childhood
Scale Name: Adverse Childhood Experiences (ACEs) Scale Ranges: 0-19, average total score is reported Higher values indicate more risk (worse outcome) and lower values indicate less risk (better out ones).
Time frame: up to 12 months
357 parent/child dyads were enrolled in the main RCT and provided their information for data analyses. A dyad refers to one parent and one child who were enrolled in the study.
| Milestone | Usual Care (Control) | Family Navigator (Intervention) |
|---|---|---|
| Started | 174 | 183 |
| Completed | 153 | 152 |
| Not completed | 21 | 31 |
| Withdrew: Withdrawal by subject | 4 | 7 |
| Withdrew: Lost to follow-up | 17 | 24 |
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.
| score on a scale | Usual Care (Control) | Family Navigator (Intervention) |
|---|---|---|
| Evaluation of the Child's Cognitive Functioning (i.e., Sensorimotor Development, Problem Solving Skills) | 83.50 (55 to 115) | 81.94 (55 to 110) |
Completion of early intervention referrals defined as completing a multidisciplinary assessment (MDE).
| Participants | Usual Care (Control) | Family Navigator (Intervention) |
|---|---|---|
| MDE Completed | 114 | 143 |
| MDE Not Completed | 56 | 34 |
Initiation of early intervention services if deemed eligible for services, defined as participants who started services.
| Participants | Usual Care (Control) | Family Navigator (Intervention) |
|---|---|---|
| Started EI Services | 88 | 107 |
| Did not Start EI Services | 5 | 7 |
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.
| score on a scale | Usual Care (Control) | Family Navigator (Intervention) |
|---|---|---|
| Evaluation of the Child's Overall Language Functioning (Receptive and Expressive Language Skills and Abilities) | 79.39 (47 to 118) | 78.71 (47 to 132) |
Changes in state policy regarding early intervention services. During the time of the study, the COVID-19 pandemic began, which affected early intervention services and policies. This timeline is broken down into the following time periods. Period 1-Early Intervention in person pre pandemic: Study start date - March 19th, 2020 Period 2-Early Intervention complete closure: March 20th, 2020 - early April 2020 Period 3: Early Intervention Virtual Only: early April 2020 - June 2nd, 2020 Period 4: Early Intervention Hybrid: June 3rd, 2020 - current (in line with Governor Wolf's process to reopen plan, this was when services and evaluations were done both virtually and in person)
| Participants | Usual Care (Control) | Family Navigator (Intervention) |
|---|---|---|
| Participants enrolled during Period 1 | 60 | 65 |
| Participants enrolled during Period 2 | 0 | 0 |
| Participants enrolled during Period 3 | 0 | 0 |
| Participants enrolled during Period 4 | 114 | 118 |
Scale Name: Parent Early Intervention (EI) Engagement Questionnaire Description: Modified and validated version of the Client Engagement in Child Protective Services (CECPS) questionnaire which evaluates the caregiver(s) perceived extent of involvement, in the early intervention process. Scale Ranges: 9 items, split up in to 3 factors/categories, are scored on a likert scale from 1-5. Two items are reverse scored during analysis. 1 indicates poor engagement (poor outcome) and 5 indicates high engagement (high outcome). Each item can be scored 1-5. When items are analyzed by factor/category, the average is taken from all items in that factor/category (can be anywhere in the range of 1-5).
| score on a scale | Usual Care (Control) | Family Navigator (Intervention) |
|---|---|---|
| Factor 1 | 4.16 ± 1.01 | 4.18 ± 1.07 |
| Factor 2 | 4.68 ± .77 | 4.68 ± .85 |
| Factor 3 | 3.74 ± 1.09 | 3.98 ± 1.11 |
Scale Name: Adverse Childhood Experiences (ACEs) Scale Ranges: 0-19, average total score is reported Higher values indicate more risk (worse outcome) and lower values indicate less risk (better out ones).
| score on a scale | Usual Care (Control) | Family Navigator (Intervention) |
|---|---|---|
| Measure of Adversity Experienced in Childhood | 4.44 (0 to 19) | 4.11 (0 to 19) |
Collected over Through study completion, an average of 12 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care (Control) | 0/174 (0%) | 0/174 (0%) | 0/174 (0%) |
| Family Navigator (Intervention) | 0/183 (0%) | 0/183 (0%) | 0/183 (0%) |
We are reporting on participant data from 357 parent/child dyads, 174 in the control arm and 183 in the intervention arm.
| Age, Continuous(months) | Usual Care (Control) | Family Navigator (Intervention) | Total |
|---|---|---|---|
| Mean | 20.6 (6.4 to 29.9) | 20.8 (4.8 to 29.9) | 20.7 (4.8 to 29.9) |
| Age, Continuous(years) | Usual Care (Control) | Family Navigator (Intervention) | Total |
|---|---|---|---|
| Mean | 30.9 ± 6.7 | 30.9 ± 7.0 | 30.9 ± 6.9 |
| Sex: Female, Male(Participants) | Usual Care (Control) | Family Navigator (Intervention) | Total |
|---|---|---|---|
| Female | 55 | 62 | 117 |
| Male | 119 | 121 | 240 |
| Sex: Female, Male(Participants) | Usual Care (Control) | Family Navigator (Intervention) | Total |
|---|---|---|---|
| Female | 162 | 172 | 334 |
| Male | 12 | 11 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care (Control) | Family Navigator (Intervention) | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 6 | 13 |
| Not Hispanic or Latino | 167 | 177 | 344 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care (Control) | Family Navigator (Intervention) | Total |
|---|---|---|---|
| Hispanic or Latino | 16 | 16 | 32 |
| Not Hispanic or Latino | 158 | 166 | 324 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Usual Care (Control) | Family Navigator (Intervention) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 7 | 6 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 107 | 132 | 239 |
| White | 34 | 27 | 61 |
| More than one race | 26 | 18 | 44 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Usual Care (Control) | Family Navigator (Intervention) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 7 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 111 | 136 | 247 |
| White | 37 | 28 | 65 |
| More than one race | 14 | 5 | 19 |
| Unknown or Not Reported | 4 | 7 | 11 |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Statistical analysis plan
Time frame: 12 months after the end of the final year of funding.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital of Philadelphia →