Clinical trial NCT06145659: School-based Support for Pre-school Aged Children With Developmental Disabilities and Delays
Official title: Educational-Clinical Linkage to Improve Health Equity for Children With Developmental Delays and Disabilities From Marginalized Communities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Delay
Keywords: primary care
implementation
linkage
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2023-11-24
Enrollment: 320
Sex: ALL
Minimum age (years): 36
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Percent of children who enroll in a designated early childhood special education (ECSE) program or Chicago Public School
timeFrame: Up to 12 months
measure: Percent of children who receive school-based therapies
timeFrame: Up to 12 months
measure: Timeliness of ECSE services
timeFrame: Up to 12 months
measure: Percent of children who complete each step of IEP process
timeFrame: up to 12 months
Secondary outcomes:
measure: Child quality of life
timeFrame: Baseline, 12 month follow up
measure: Child sleep habits
timeFrame: Baseline, 12 month follow up
measure: Parenting stress
timeFrame: Baseline, 12 month follow up
measure: Family Functioning
timeFrame: Baseline, 12 month follow up
measure: Family-centered care self-assessment tool
timeFrame: Baseline, 12 month follow up
measure: Satisfaction with the Interpersonal Relationship with the Navigator (PSN-I)
timeFrame: Up to 6 months
measure: Acceptability of Intervention Measure
timeFrame: Up to 6 months
measure: Adoption
timeFrame: up to 6 months
measure: Intervention Appropriateness Measure (IAM)
timeFrame: up to 6 months
measure: Penetration
timeFrame: up to 6 months
measure: Feasibility of Intervention Measure
timeFrame: up to 6 months
measure: Fidelity
timeFrame: up to 6 months
measure: Cost
timeFrame: up to 6 months
measure: Parental Quality of Life
timeFrame: Baseline and 12 months
Other outcomes:
measure: Positive Protective Factors (Resilience, Social Connections, Concrete Support in Time of Need)
timeFrame: 6, 12 months
measure: Parent Patient Activation Measure Parent Patient Activation Measure Parent Patient Activation Measure
timeFrame: 6, 12 months
Locations:
city: Chicago
country: United States
facility: UI Health
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Reshma Shah, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: