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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD011598 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Guevara, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
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.
12 months after the end of the final year of funding.
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We are reporting on participant data from 357 participants, 174 in the control arm and 183 in the intervention arm.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
We are reporting on participant data from 357 parent/child dyads, 174 in the control arm and 183 in the intervention arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Family Navigator (Intervention) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | age refers to the child in the parent/child dyad |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Full Range | score on a scale | 12 months |
Through study completion, an average of 12 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Guevara | Children's Hospital of Philadelphia | 2155901130 | guevara@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2023 | Jul 8, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 3, 2024 | Jul 8, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 17, 2023 | Aug 2, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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.
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Research staff collecting study data will be unaware of study arm of participants.
|
| 12 months |
| up to 12 months |
| 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). | up to 12 months |
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.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| months |
|
| Age, Continuous | age of the parent in the parent/child dyad | Mean | Standard Deviation | years |
|
| Sex: Female, Male | sex refers to the child in the parent/child dyad | Count of Participants | Participants |
|
| Sex: Female, Male | sex refers to the parent of the parent/child dyad | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | ethnicity of the child in the parent/child dyad | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | ethnicity of the parent in the parent/child dyad | Count of Participants | Participants |
|
| Race (NIH/OMB) | race of the child in the parent/child dyad | Count of Participants | Participants |
|
| Race (NIH/OMB) | race of the parent in the parent/child dyad | Count of Participants | Participants |
|
| Region of Enrollment | refers to region of enrollment for the parent/child dyad | Number | participants |
|
| Caregiver Education Level | education level of the parent in the parent/child dyad | Count of Participants | Participants |
|
| Caregiver income | income of the parent in the parent/child dyad | Count of Participants | Participants |
|
| Caregiver Marital Status | marital status of the parent in the parent/child dyad | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
| OG001 | 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. |
|
|
|
| Primary | Early Intervention Referral Completion | Completion of early intervention referrals defined as completing a multidisciplinary assessment (MDE). | 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. | Posted | Count of Participants | Participants | up to 12 months |
|
|
|
|
| Primary | Early Intervention Services Initiation | Initiation of early intervention services if deemed eligible for services, defined as participants who started services. | 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. | Posted | Count of Participants | Participants | up to 12 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Full Range | score on a scale | 12 months |
|
|
|
|
| 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) | 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. | Posted | Count of Participants | Participants | up to 12 months |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | up to 3 months |
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|
|
| 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). | 312 families completed the ACES survey. Some families did not complete this self-report measure, which is why this number is less than 357. | Posted | Mean | Full Range | score on a scale | up to 12 months |
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|
|
|
| 0 |
| 174 |
| 0 |
| 174 |
| 0 |
| 174 |
| EG001 | 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. | 0 | 183 | 0 | 183 | 0 | 183 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| Participants enrolled during Period 3 |
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| Participants enrolled during Period 4 |
|
| Factor 3 |
|
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. |
| t-test, 2 sided |
| .995 |
| Equivalence |
two tailed t-test to compare the means of factor 2 between groups |
| 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. | t-test, 2 sided | .049 | Equivalence | two tailed t-test to compare the means of factor 3 between groups |