Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06145659 | RECRUITING | Developmental Delay

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

University of Illinois at Chicago

Brief 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.

Condition or disease

Developmental Delay

Intervention/treatment

Preschool and Me

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 320 participants
Masking : SINGLE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Educational-Clinical Linkage to Improve Health Equity for Children With Developmental Delays and Disabilities From Marginalized Communities
Actual Study Start Date : 2024-03-25
Estimated Primary Completion Date : 2028-09-01
Estimated Study Completion Date : 2029-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 36 Months
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Parent-child dyads who meet inclusion criteria will be enrolled.
  • Child inclusion criteria are
    • 1. Meets age requirements for early childhood special education (ECSE) services for Illinois (i.e., 3-5 years old);
    • 2. diagnosed with a developmental delay or disability (DD) or determined to be at risk for DD (clinical concerns raised by primary care provider/healthcare provider or by parents at the time of enrollment);
    • 3. is not receiving any ECSE services.
    Exclusion Criteria
    • if inclusion criteria is met, no other exclusion criteria will be applied.
    • Parent inclusion criteria are
      • 1. aged18 years or older;
      • 2. lives in Chicago;
      • 3. speaks English or Spanish;
      • 4. a legal guardian of a child who meets inclusion criteria.
    • School-based Support for Pre-school Aged Children With Developmental Disabilities and Delays

    Location Details

    NCT06145659

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, Illinois

    UI Health

    Chicago, Illinois, United States, 60612