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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04118452
Other study ID # 19-001556
Secondary ID 7R01HD092406-02
Status Completed
Phase N/A
First received
Last updated
Start date January 17, 2020
Est. completion date May 23, 2023

Study information

Verified date March 2024
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 565
Est. completion date May 23, 2023
Est. primary completion date May 23, 2023
Accepts healthy volunteers No
Gender All
Age group 11 Months to 42 Months
Eligibility Inclusion Criteria: - A patient in one of the four partner community clinic systems (ChapCare, Kaiser Permanente LA Medical Center, South Central Family Health Center, and Via Care) - A patient with an upcoming one- to three-year old well child appointment scheduled - Child aged 11-42 months Exclusion Criteria: - Parent who does not speak English or Spanish - Child with history of developmental and/or behavioral diagnosis or having been referred to or received developmental and/or behavioral services. - Child has a sibling already enrolled in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States South Central Family Health Center Los Angeles California
United States Via Care Los Angeles California
United States ChapCare Pasadena California

Sponsors (5)

Lead Sponsor Collaborator
University of California, Los Angeles Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Information and Referral Federation of Los Angeles County (211 LA County), Kaiser Permanente School of Medicine, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
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, 2) the percentage of children who are deemed eligible for services by service organizations, and 3) the percentage of children who receive services. 6 months after enrollment
Primary Child Developmental Outcomes The PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level) will be used to determine developmental assessment scores. All children will receive the language sub-scale of this instrument, and those children who screened positive (at high or moderate risk on the PEDS Online) will receive the full assessment. Change in child developmental assessment score between baseline and 24 months after enrollment
Primary Intervention Cost / Benefit Analysis Intervention costs per child screened are composed of the 211LA program costs for care coordination and the costs of services received. Intervention benefits are the long-term benefits of service receipt in terms of potential changes in employment, income, crime, and life expectancy. 24 months after enrollment
Secondary Number of referrals, number of children eligible for services, and number of children who have received services The secondary outcome will be assessed by the average number of 1) referrals made, 2) services for which children are deemed eligible, and 3) services received for each family; 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. 6 months after enrollment
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