NCT06145659

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 36 Months
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Developmental Delay

Interventions

Type	Name	Description
BEHAVIORAL	Preschool and Me	Utilizes patient navigation services and a medical-educational care plan to support linkages between medical and educational systems

Timeline

• Start date: 2024-03-25
• Primary completion: 2028-09-01
• Completion: 2029-01-01
• First posted: 2023-11-24
• Last updated: 2025-04-18

Locations

1 site across 1 country: United States