Development, Child, Development Delay
Conditions
Keywords
Early Intervention, Developmental outcomes, Health disparities, Early Childhood
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.
Interventions
BEHAVIORALFamily 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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Research staff collecting study data will be unaware of study arm of participants.
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 29 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Child's Cognitive Functioning (i.e., Sensorimotor Development, Problem Solving Skills) | 12 months | 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. |
| Early Intervention Referral Completion | up to 12 months | Completion of early intervention referrals defined as completing a multidisciplinary assessment (MDE). |
| Early Intervention Services Initiation | up to 12 months | Initiation of early intervention services if deemed eligible for services, defined as participants who started services. |
| Evaluation of the Child's Overall Language Functioning (Receptive and Expressive Language Skills and Abilities) | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Public Policy Changes | up to 12 months | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Measure of Adversity Experienced in Childhood | up to 12 months | 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). |
| An Evaluation of Parent/Family Engagement in the Early Intervention Process | up to 3 months | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
We are reporting on participant data from 357 participants, 174 in the control arm and 183 in the intervention arm.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 174 |
| 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.
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. | 183 |
| Total | 357 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 24 |
| Overall Study | Withdrawal by Subject | 4 | 7 |
Baseline characteristics
| Characteristic | Family Navigator (Intervention) | Total | Usual Care (Control) |
|---|---|---|---|
| Age, Continuous | 30.9 years STANDARD_DEVIATION 7 | 20.7 months | 30.9 years STANDARD_DEVIATION 6.7 |
| Caregiver Education Level College or graduate degree | 46 Participants | 94 Participants | 48 Participants |
| Caregiver Education Level High school and/or some college | 132 Participants | 242 Participants | 110 Participants |
| Caregiver Education Level Less than high school | 5 Participants | 21 Participants | 16 Participants |
| Caregiver income $14,999 or less | 32 Participants | 68 Participants | 36 Participants |
| Caregiver income $15,000 - $34,999 | 68 Participants | 126 Participants | 58 Participants |
| Caregiver income $35,000 - 54,999 | 37 Participants | 77 Participants | 40 Participants |
| Caregiver income $55,000 or more | 45 Participants | 82 Participants | 37 Participants |
| Caregiver income information not provided | 1 Participants | 4 Participants | 3 Participants |
| Caregiver Marital Status Living Together As if Married or Married | 81 Participants | 171 Participants | 90 Participants |
| Caregiver Marital Status Separated or Divorced | 5 Participants | 10 Participants | 5 Participants |
| Caregiver Marital Status Single | 97 Participants | 176 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 32 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 177 Participants | 344 Participants | 167 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 136 Participants | 247 Participants | 111 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 44 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) White | 28 Participants | 61 Participants | 37 Participants |
| Region of Enrollment United States | 183 participants | 357 participants | 174 participants |
| Sex: Female, Male Female | 62 Participants | 117 Participants | 162 Participants |
| Sex: Female, Male Male | 11 Participants | 240 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 174 | 0 / 183 |
| other Total, other adverse events | 0 / 174 | 0 / 183 |
| serious Total, serious adverse events | 0 / 174 | 0 / 183 |
Outcome results
Primary
Early Intervention Referral Completion
Completion of early intervention referrals defined as completing a multidisciplinary assessment (MDE).
Time frame: up to 12 months
Population: We were only able to collect data from 347 participants. The reason this number does not equal 357 participants is due to participants dropping out or being withdrawn from the study before we collected early intervention data from their provider's entities.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care (Control) | Early Intervention Referral Completion | MDE Completed | 114 Participants |
| Usual Care (Control) | Early Intervention Referral Completion | MDE Not Completed | 56 Participants |
| Family Navigator (Intervention) | Early Intervention Referral Completion | MDE Completed | 143 Participants |
| Family Navigator (Intervention) | Early Intervention Referral Completion | MDE Not Completed | 34 Participants |
Comparison: Chi-square test of independence to determine if there was a significant difference between intervention arms for those who completed a multidisciplinary evaluation (referral completed).p-value: 0.004Chi-squared
Primary
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
Population: 207 participants were analyzed; this number came from the 207 participants who had completed their EI referral AND had been eligible for EI services or regular tracking. 200 for eligible for early intervention services and 7 were eligible for developmental tracking every 3 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care (Control) | Early Intervention Services Initiation | Started EI Services | 88 Participants |
| Usual Care (Control) | Early Intervention Services Initiation | Did not Start EI Services | 5 Participants |
| Family Navigator (Intervention) | Early Intervention Services Initiation | Started EI Services | 107 Participants |
| Family Navigator (Intervention) | Early Intervention Services Initiation | Did not Start EI Services | 7 Participants |
Comparison: Chi-square test of independence to determine if there was a significant difference between intervention arms for those who began early intervention services.p-value: 0.82Chi-squared
Primary
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
Population: A total of 223 participants completed the cognitive section of the Bayley III assessment. The reason why this number is not equal to 357 is because some families were unable to make it in person for the assessment or the assessment could not have been completed due to child behavior.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care (Control) | Evaluation of the Child's Cognitive Functioning (i.e., Sensorimotor Development, Problem Solving Skills) | 83.50 score on a scale |
| Family Navigator (Intervention) | Evaluation of the Child's Cognitive Functioning (i.e., Sensorimotor Development, Problem Solving Skills) | 81.94 score on a scale |
p-value: 0.3t-test, 2 sided
Primary
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
Population: A total of 220 participants completed the language section of the Bayley III assessment. The reason why this number is not equal to 357 is because some families were unable to make it in person for the assessment or the assessment could not have been completed due to child behavior.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care (Control) | Evaluation of the Child's Overall Language Functioning (Receptive and Expressive Language Skills and Abilities) | 79.39 score on a scale |
| Family Navigator (Intervention) | Evaluation of the Child's Overall Language Functioning (Receptive and Expressive Language Skills and Abilities) | 78.71 score on a scale |
p-value: 0.69t-test, 2 sided
Secondary
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
Population: This analysis includes participants who were randomized into a study condition. Three participants were withdrawn immediately after enrollment, leaving a total of 357 participants randomized.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care (Control) | Public Policy Changes | Participants enrolled during Period 1 | 60 Participants |
| Usual Care (Control) | Public Policy Changes | Participants enrolled during Period 2 | 0 Participants |
| Usual Care (Control) | Public Policy Changes | Participants enrolled during Period 3 | 0 Participants |
| Usual Care (Control) | Public Policy Changes | Participants enrolled during Period 4 | 114 Participants |
| Family Navigator (Intervention) | Public Policy Changes | Participants enrolled during Period 4 | 118 Participants |
| Family Navigator (Intervention) | Public Policy Changes | Participants enrolled during Period 1 | 65 Participants |
| Family Navigator (Intervention) | Public Policy Changes | Participants enrolled during Period 3 | 0 Participants |
| Family Navigator (Intervention) | Public Policy Changes | Participants enrolled during Period 2 | 0 Participants |
Other Pre-specified
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
Population: This data came from participants who had completed the parent engagement questionnaire at the 3 month follow up timepoints. Not all participants completed this survey, which is why the total number of participants analyzed is 333 and not 357.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (Control) | An Evaluation of Parent/Family Engagement in the Early Intervention Process | Factor 1 | 4.16 score on a scale | Standard Deviation 1.01 |
| Usual Care (Control) | An Evaluation of Parent/Family Engagement in the Early Intervention Process | Factor 2 | 4.68 score on a scale | Standard Deviation 0.77 |
| Usual Care (Control) | An Evaluation of Parent/Family Engagement in the Early Intervention Process | Factor 3 | 3.74 score on a scale | Standard Deviation 1.09 |
| Family Navigator (Intervention) | An Evaluation of Parent/Family Engagement in the Early Intervention Process | Factor 1 | 4.18 score on a scale | Standard Deviation 1.07 |
| Family Navigator (Intervention) | An Evaluation of Parent/Family Engagement in the Early Intervention Process | Factor 2 | 4.68 score on a scale | Standard Deviation 0.85 |
| Family Navigator (Intervention) | An Evaluation of Parent/Family Engagement in the Early Intervention Process | Factor 3 | 3.98 score on a scale | Standard Deviation 1.11 |
Comparison: Analysis of factor 1 items from the parent engagement questionnaire. Factor 1 (Buy-in) I am open to getting EI for my child. EI can help my child. EI can teach me new ways to help my child.p-value: 0.858t-test, 2 sided
Comparison: Analysis of factor 2 items from the parent engagement questionnaire.~Factor 2 (early intervention consequences):~EI could have negative consequences for my child. Getting EI for my child reflects negatively on me as a parent.p-value: 0.995t-test, 2 sided
Comparison: Analysis of factor 3 items from the parent engagement questionnaire.~Factor 3 (Knowledge/Self-Efficacy):~I know how to get EI for my child. I understand how the EI process works. If I have questions about EI, I know who to call. 12. I know my child's rights to EI under the law.p-value: 0.049t-test, 2 sided
Other Pre-specified
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
Population: 312 families completed the ACES survey. Some families did not complete this self-report measure, which is why this number is less than 357.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care (Control) | Measure of Adversity Experienced in Childhood | 4.44 score on a scale |
| Family Navigator (Intervention) | Measure of Adversity Experienced in Childhood | 4.11 score on a scale |
Comparison: A logistic regression was run to determine if the intervention arm, adjusted for child sex, income, maternal education, and primary care site, was associated with the completion of early intervention referrals for families with an adverse childhood experience survey score of greater than 2.p-value: 0.0295% CI: [1.09, 3.21]Regression, Logistic