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| ID | Type | Description | Link |
|---|---|---|---|
| 7R01HD092406-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kaiser Permanente School of Medicine | OTHER |
| Virginia Commonwealth University | OTHER |
| Information and Referral Federation of Los Angeles County (211 LA County) | UNKNOWN |
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The proposed project is a randomized controlled trial of a telephone-based early childhood developmental care coordination system, in partnership with 2-1-1 Los Angeles County (211LA), part of a national network of 2-1-1 call centers covering 93% of the US population. The study will test the effectiveness of 211LA in increasing referrals for developmental evaluation, increasing the numbers of children deemed eligible for services, and increasing the number of children actually receiving interventions.
The trial will enroll 662 children ages 1-3 years who receive well-child care at one of 10 partner clinic sites (belonging to 4 partner clinic systems). The research study team will conduct developmental screening on all children using the Parental Evaluation of Developmental Status (PEDS) Online system, and randomize children 1:1 into intervention (connection to 211LA for developmental care coordination + usual care) or control (usual care alone, with developmental care coordination conducted by clinic staff).
Primary outcomes will include referrals to early intervention evaluations, eligibility for intervention services, and receipt of services. The investigators will measure these outcomes through parent report, medical record review, and 211LA data, at 6 months after enrollment. For children with elevated developmental risk based on the PEDS Online results, the study will assess development using the PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level), conducted at baseline as well as 12 and 24 months after enrollment. For all children, research study team personnel will administer the language subscale of the PEDS:DM-AL at baseline, 12 months and 24 months, to evaluate development over time in the two groups. The investigators will measure behavioral outcomes for all children using the externalizing behavior subscale of the Child Behavior Checklist.
Expected findings include higher rates of referrals, eligibility, and receipt of intervention services among intervention group participants, and greater developmental gains among children in the intervention group. The study will also examine the costs of the program in relation to these outcomes, to estimate the costs and potential long-term benefits of this model. If effective, the model has the potential to disseminate rapidly throughout the 2-1-1 network and transform developmental care coordination in the US.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention + Usual Care + Developmental Screening Results | Experimental | Intervention group families will receive usual care and developmental screening results will be shared with each child's primary care provider. In addition, they will be connected via telephone to 2-1-1 prior to their scheduled well-child visit for the telephone-based early childhood development care coordination intervention. |
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| Usual Care + Developmental Screening Results | No Intervention | This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone-based early childhood developmental care coordination | Behavioral | The 211LA care coordinator will review developmental screening results and provide referral recommendations to the family and use 211LA's extensive resource directory and agency relationships to identify appropriate referrals. The 211LA care coordinator will provide a report to the clinical provider containing recommendations for follow-up and a care coordination plan. The report will be scanned into the EMR (Electronic Medical Record) by clinic staff and be available for provider review. The 211LA care coordinator will also make all recommended referrals and will call the family monthly until 1) children begin receiving services, 2) families refuse services, or 3) children are deemed ineligible by service providers. |
| Measure | Description | Time Frame |
|---|---|---|
| Referral to, Eligibility for, and Receipt of Early Childhood Developmental Services 6 Months After Enrollment | The primary outcome will be assessed by 1) the percentage of children who are successfully referred to early childhood service organizations for evaluation, and 2) the percentage of children who receive services. | 6 months after enrollment |
| Child Developmental Outcomes | The PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level) is an assessment measure of development, social-emotional, and behavioral health that provides age-equivalent and percent delay scores for each domain measured. The domains included in the full assessment are: fine motor, gross motor, expressive language, receptive language, self-help, social-emotional, and academic/pre-academic, and cognitive. This study utilizes the expressive language and receptive language domains to measure child developmental outcomes. This measure will be reported as a Rough Standard Score (RSS), the child's "developmental age" as shown by the tool divided by their actual age. A score of 100 means the child is scored by the instrument as being where we would expect developmentally given their age; lower scores mean the child is developmentally delayed, and higher scores mean the child is ahead of the curve. | Baseline and 24 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | The secondary outcome will be assessed by the number of 1) children with referrals made, and 2) children with services received; the investigators will primarily consider referrals to high-level intervention services for developmental and behavioral problems, but will also track referrals to development-related preventive and support services. Intervention services include Part C early intervention (EI), Part B early childhood special education (ECSE), physical therapy (PT), occupational therapy (OT), and speech therapy. Early care and education (ECE) includes child care, preschool, Head Start, and Early Head Start. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul J Chung, MD MS | Kaiser Permanente School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Central Family Health Center | Los Angeles | California | 90011 | United States | ||
| Via Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30894408 | Background | Nelson BB, Thompson LR, Herrera P, Biely C, Arriola Zarate D, Aceves I, Estrada I, Chan V, Orantes C, Chung PJ. Telephone-Based Developmental Screening and Care Coordination Through 2-1-1: A Randomized Trial. Pediatrics. 2019 Apr;143(4):e20181064. doi: 10.1542/peds.2018-1064. |
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De-identified individual participant data for all primary and secondary outcome measures will be shared.
Data will be shared within 2 years of study completion.
Proposals should be directed to paul.j.chung@kp.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website, to be provided when requests are approved.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention + Usual Care + Developmental Screening Results | Intervention group families will receive usual care and developmental screening results will be shared with each child's primary care provider. In addition, they will be connected via telephone to 2-1-1 prior to their scheduled well-child visit for the telephone-based early childhood development care coordination intervention. Telephone-based early childhood developmental care coordination: The 211LA care coordinator will review developmental screening results and provide referral recommendations to the family and use 211LA's extensive resource directory and agency relationships to identify appropriate referrals. The 211LA care coordinator will provide a report to the clinical provider containing recommendations for follow-up and a care coordination plan. The report will be scanned into the EMR by clinic staff and be available for provider review. The 211LA care coordinator will also make all recommended referrals and will call the family monthly until 1) children begin receiving services, 2) families refuse services, or 3) children are deemed ineligible by service providers. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2023 |
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| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| NIH |
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| 6 months after enrollment |
| Los Angeles |
| California |
| 90022 |
| United States |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| ChapCare | Pasadena | California | 91103 | United States |
| FG001 | Usual Care + Developmental Screening Results | This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider. |
| 6 Month Survey |
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| 12 Month Survey |
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| 24 Month Survey |
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| COMPLETED | Completed 12 Month or 24 Month Follow-Up Survey |
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| NOT COMPLETED |
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565 participants were enrolled in the study and 559 completed the baseline survey, including demographic information.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention + Usual Care + Developmental Screening Results | Intervention group families will receive usual care and developmental screening results will be shared with each child's primary care provider. In addition, they will be connected via telephone to 2-1-1 prior to their scheduled well-child visit for the telephone-based early childhood development care coordination intervention. Telephone-based early childhood developmental care coordination: The 211LA care coordinator will review developmental screening results and provide referral recommendations to the family and use 211LA's extensive resource directory and agency relationships to identify appropriate referrals. The 211LA care coordinator will provide a report to the clinical provider containing recommendations for follow-up and a care coordination plan. The report will be scanned into the EMR by clinic staff and be available for provider review. The 211LA care coordinator will also make all recommended referrals and will call the family monthly until 1) children begin receiving services, 2) families refuse services, or 3) children are deemed ineligible by service providers. |
| BG001 | Usual Care + Developmental Screening Results | This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Referral to, Eligibility for, and Receipt of Early Childhood Developmental Services 6 Months After Enrollment | The primary outcome will be assessed by 1) the percentage of children who are successfully referred to early childhood service organizations for evaluation, and 2) the percentage of children who receive services. | Posted | Number | percentage of children | 6 months after enrollment |
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| Primary | Child Developmental Outcomes | The PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level) is an assessment measure of development, social-emotional, and behavioral health that provides age-equivalent and percent delay scores for each domain measured. The domains included in the full assessment are: fine motor, gross motor, expressive language, receptive language, self-help, social-emotional, and academic/pre-academic, and cognitive. This study utilizes the expressive language and receptive language domains to measure child developmental outcomes. This measure will be reported as a Rough Standard Score (RSS), the child's "developmental age" as shown by the tool divided by their actual age. A score of 100 means the child is scored by the instrument as being where we would expect developmentally given their age; lower scores mean the child is developmentally delayed, and higher scores mean the child is ahead of the curve. | Posted | Mean | Standard Deviation | Standardized Score | Baseline and 24 months after enrollment |
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| Secondary | Number of Children Who Have Received Referrals and Number of Children Who Have Received Services | The secondary outcome will be assessed by the number of 1) children with referrals made, and 2) children with services received; the investigators will primarily consider referrals to high-level intervention services for developmental and behavioral problems, but will also track referrals to development-related preventive and support services. Intervention services include Part C early intervention (EI), Part B early childhood special education (ECSE), physical therapy (PT), occupational therapy (OT), and speech therapy. Early care and education (ECE) includes child care, preschool, Head Start, and Early Head Start. | Posted | Number | participants | 6 months after enrollment |
|
2 years
This research study is considered minimal risk and was conducted with participants who were healthy children recruited from usual care at health clinics. As such, they were not at risk for all-cause mortality, serious adverse events, or other adverse events.
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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 | Intervention + Usual Care + Developmental Screening Results | Intervention group families will receive usual care and developmental screening results will be shared with each child's primary care provider. In addition, they will be connected via telephone to 2-1-1 prior to their scheduled well-child visit for the telephone-based early childhood development care coordination intervention. Telephone-based early childhood developmental care coordination: The 211LA care coordinator will review developmental screening results and provide referral recommendations to the family and use 211LA's extensive resource directory and agency relationships to identify appropriate referrals. The 211LA care coordinator will provide a report to the clinical provider containing recommendations for follow-up and a care coordination plan. The report will be scanned into the EMR by clinic staff and be available for provider review. The 211LA care coordinator will also make all recommended referrals and will call the family monthly until 1) children begin receiving services, 2) families refuse services, or 3) children are deemed ineligible by service providers. | 0 | 278 | 0 | 278 | 0 | 278 |
| EG001 | Usual Care + Developmental Screening Results | This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider. | 0 | 281 | 0 | 281 | 0 | 281 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Chung, Professor and Principal Investigator | University of California, Los Angeles & Kaiser Permanente School of Medicine | 626-710-0389 | paul.j.chung@kp.org |
| Nov 21, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2023 | May 5, 2025 | ICF_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG001 | Usual Care + Developmental Screening Results | This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider. |
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| OG001 | High or Moderate Risk - Intervention + Usual Care + Developmental Screening Results | Intervention group families will receive usual care and developmental screening results will be shared with each child's primary care provider. In addition, they will be connected via telephone to 2-1-1 prior to their scheduled well-child visit for the telephone-based early childhood development care coordination intervention. Telephone-based early childhood developmental care coordination: The 211LA care coordinator will review developmental screening results and provide referral recommendations to the family and use 211LA's extensive resource directory and agency relationships to identify appropriate referrals. The 211LA care coordinator will provide a report to the clinical provider containing recommendations for follow-up and a care coordination plan. The report will be scanned into the EMR by clinic staff and be available for provider review. The 211LA care coordinator will also make all recommended referrals and will call the family monthly until 1) children begin receiving services, 2) families refuse services, or 3) children are deemed ineligible by service providers. This is a subgroup of children enrolled in the intervention who, at baseline, were determined to have a moderate or high risk for developmental delay. |
| OG002 | Usual Care + Developmental Screening Results | This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider. |
| OG003 | High or Moderate Risk - Usual Care + Developmental Screening Results | This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider. This is a subgroup of children enrolled in usual care who, at baseline, were determined to have a moderate or high risk for developmental delay. |
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