School-based Support for Pre-school Aged Children With Developmental Disabilities and Delays — PreM  

Developmental Delay Clinical Trial

Official title: Educational-Clinical Linkage to Improve Health Equity for Children With Developmental Delays and Disabilities From Marginalized Communities

Status Recruiting

Clinical Trial Summary

This proposal aims to test whether a proposed community-clinical linkage (CCL), an educational-medical linkage model, improves access to school-based services and subsequent child, parent, family and health service outcomes and offers a promising strategy to address longstanding racial, ethnic and income health care disparities among families with preschool children with developmental delays and disabilities. The investigators designed an educational-clinical linkage model, Preschool and Me (PreM) which incorporates key components of a CCL. It also utilizes a personalized medical-education care plan with remote lay navigator support to increase access to school-based services.

Clinical Trial Description

Participants (n=320) will be randomized to either: 1) 6 months of PreM (intervention group) or 2) a waitlist control arm receiving the intervention after a 6-month delay. All participants will be followed for 12 months with data collection occurring at 4 timepoints (baseline, 3-, 6- and 12-months). There will also be a simultaneously conducted mixed-methods implementation evaluation focusing on implementation outcomes to serve as indicators for implementation success; measures of implementation quality; and intermediate outcomes to understand and address successes and failures in relation to clinical outcomes. ;

Related Conditions & MeSH terms

• Developmental Delay

• NCT number: NCT06145659
• Study type: Interventional
• Source: University of Illinois at Chicago
• Contact: Reshma Shah, MD, MPH
• Phone: 3125235030
• Email: reshmamd@uic.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Completion date: January 2029