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

University of Illinois

Status: Enrolling

Conditions: Developmental Delay

Treatments: Behavioral: Preschool and Me

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06145659

2023-1361

R01NR021155 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 36+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

Linkage Model

Experimental group

Description:

Preschool and Me intervention

Treatment:

Behavioral: Preschool and Me

Treatment as Usual

No Intervention group

Description:

Preschool and Me intervention is not used