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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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04118452
Study type Interventional
Source University of California, Los Angeles
Contact
Status Completed
Phase N/A
Start date January 17, 2020
Completion date May 23, 2023

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