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

NCT06145659 | Active Not Recruiting DMC

• 2 other identifiers: 2023-1361R01NR021155
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Delay

Keywords

primary care; implementation; linkage

Outcome Measures

Primary Outcomes (4)

• Percent of children who enroll in a designated early childhood special education (ECSE) program or Chicago Public School

  Increased access to early childhood special education (ECSE) as measured by enrollment in designated Chicago Early Learning Education Program or Chicago Public School

  Up to 12 months

• Percent of children who receive school-based therapies

  Increased access to early childhood special education (ECSE) services as measured by receipt of school-based services

  Up to 12 months

• Timeliness of ECSE services

  Calculate the time (number of days) from a child's 3rd birthday to 1) date of Individualized Education Plan (IEP) request; 2) date of IEP eligibility meeting; 3) attendance at preschool (first day); and 4) start date of first school-based therapy for those found eligible.

  Up to 12 months

• Percent of children who complete each step of IEP process

  Percent of children who complete each step of IEP process

  up to 12 months

Secondary Outcomes (14)

• Child quality of life

  Baseline, 12 month follow up

• Child sleep habits

  Baseline, 12 month follow up

• Parenting stress

  Baseline, 12 month follow up

• Family Functioning

  Baseline, 12 month follow up

• Family-centered care self-assessment tool

  Baseline, 12 month follow up

Other Outcomes (2)

• Positive Protective Factors (Resilience, Social Connections, Concrete Support in Time of Need)

  6, 12 months

• Parent Patient Activation Measure Parent Patient Activation Measure Parent Patient Activation Measure

  6, 12 months

Study Arms (2)

Linkage Model

EXPERIMENTAL

Preschool and Me intervention

Behavioral: Preschool and Me

Treatment as Usual

NO INTERVENTION

Preschool and Me intervention is not used

Interventions

Preschool and Me BEHAVIORAL

Utilizes patient navigation services and a medical-educational care plan to support linkages between medical and educational systems

Linkage Model

Eligibility Criteria

• Age: 36 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets age requirements for early childhood special education (ECSE) services for Illinois (i.e., 3-5 years old);
• 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);
• is not receiving any ECSE services.

You may not qualify if:

• aged18 years or older;
• lives in Chicago;
• speaks English or Spanish;

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

UI Health

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Learning Disabilities

Interventions

Schools, Nursery

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Schools; Non-Medical Public and Private Facilities

Study Officials

• Reshma Shah, MD, MPH

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 24, 2023
• Study Start: March 25, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD from a study publication will be shared at the time of publication. Study data will be shared approximately 12 months following the end of data collection but within the funded award period.
• Access Criteria: The final study data and documentation will be made available to researchers through the Interuniversity Consortium for Political and Social Research (ICPSR) repository services. Access to data underlying publications will vary based on the publication and information on access will be available either in the publication or made available by the study PI.

Locations

US (1)