An interventional study of Preschool and Me in Developmental Delay, sponsored by University of Illinois at Chicago. Active, not recruiting at 1 site in United States. Open to participants aged 36 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Health services research
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.
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.
138 studies on the registry are indexed under Learning Disabilities; 49 are open to participants now.
This study's planned enrollment of 320 is above the median of 60 across 93 interventional studies indexed under Learning Disabilities.
Browse Learning Disabilities studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Parent-child dyads who meet inclusion criteria will be enrolled.
Child inclusion criteria are:
Exclusion Criteria:
if inclusion criteria is met, no other exclusion criteria will be applied.
Parent inclusion criteria are:
Preschool and Me intervention
Behavioral: Preschool and Me
Preschool and Me intervention is not used
Utilizes patient navigation services and a medical-educational care plan to support linkages between medical and educational systems
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
Time frame: 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
Time frame: 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.
Time frame: Up to 12 months
Percent of children who complete each step of IEP process
Percent of children who complete each step of IEP process
Time frame: up to 12 months
Child quality of life
Child quality of life will be assessed using questionnaires from the Patient Reported Outcomes Measurement Information System (PROMIS). The questionnaires will examine quality of life under the follow domains: well being, relationships, emotional distress, and health. The questionnaires utilize a 5-point likert scale with higher scores reflecting more of the measured construct within the domain.
Time frame: Baseline, 12 month follow up
Child sleep habits
Exploratory outcome assessing sleep disturbance using the PROMIS Parent Proxy Sleep Disturbance questionnaire. This 8 question survey of sleep disturbances is scored on a 5-point scale. A higher score indicates poorer sleep hygiene.
Time frame: Baseline, 12 month follow up
Parenting stress
Caregiver Strain Short Form consists of 11 items assessing the level of strain caregivers experience in caring for their child consisting of the following factors: objective strain, subjective internalized strain, and subjective externalized strain. Items are rated on a 5-point Likert-type scale that ranges from 1 (not at all) to 5 (very much). Higher scores represent greater strain.
Time frame: Baseline, 12 month follow up
Family Functioning
General Functioning 12-item subscale (GF12) of The McMaster Family Assessment Device (FAD); The FAD consists of 7 scales: affective involvement, affective responsiveness, behavioral control, communication, problem solving, roles and general family functioning. Participants are asked to rate how well each statement describes their family on a 4 point scale. Higher scores indicate worse levels of family functioning.
Time frame: Baseline, 12 month follow up
Family-centered care self-assessment tool
Family Centered Care Assessment Tool Community Systems of Services and Supports and Community Systems Integration and Care Coordination examines a participants perception of family-centered care received at their healthcare facility; Each item is rated on a 4-point Likert scale (1= never; 4= always) with higher scores indicating a greater perception of family-centered care.
Time frame: Baseline, 12 month follow up
Satisfaction with the Interpersonal Relationship with the Navigator (PSN-I)
Satisfaction with the Interpersonal Relationship with the Navigator (PSN-I) is a 9 item questionnaire that examines participants perception of their PreM navigator; Each item is rated on a 5-point Likert scale with a higher score indicating a higher satisfaction with their interpersonal relationship with the patient navigator.
Time frame: Up to 6 months
Acceptability of Intervention Measure
Acceptability of Intervention Measure examines participants acceptability of PreM; Each item is rated on a 5-point Likert scale with a higher score indicating a greater acceptability
Time frame: Up to 6 months
Adoption
Ratio of number of Primary Care Providers (PCPs) who referred to Preschool and Me (PreM) to total number of PCPs
Time frame: up to 6 months
Intervention Appropriateness Measure (IAM)
Intervention Appropriate Measure examines perception of the appropriateness of PreM; Each item is rated on a 5-point Likert scale with a higher score indicating a greater perception of appropriateness
Time frame: up to 6 months
Penetration
Ratio of number of caregivers contacted by Patient Navigator (PN) to number of caregivers referred
Time frame: up to 6 months
Feasibility of Intervention Measure
Feasibility of Intervention Measure examines perception of the feasibility of PreM; Each item is rated on a 5-point Likert scale with a higher score indicating a greater perception of feasibility
Time frame: up to 6 months
Fidelity
Per family ratio of number of PN activities conducted to number of activities that should be conducted according to protocol/job aid
Time frame: up to 6 months
Cost
Time estimates of training and supervision; Per family time estimates associated with PN activities
Time frame: up to 6 months
Parental Quality of Life
Parent Quality of Life will be assessed using PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 6a which examines satisfaction with performing one's social roles and activities. Higher scores reflect more of the measured construct (i.e., ability to participate in social roles and activities).
Time frame: Baseline and 12 months
Positive Protective Factors (Resilience, Social Connections, Concrete Support in Time of Need)
Parent Assessment of Protective Factors is a measure to assess participants' self-reported beliefs, feelings, and behaviors in the areas of Resilience, Social Connections, Concrete Support in Time of Need. Items are scored on a 5 point Likert scales with higher scores indicating a higher perceived strength level.
Time frame: 6, 12 months
Parent Patient Activation Measure Parent Patient Activation Measure Parent Patient Activation Measure
Parent Patient Activation Measure assesses perceived knowledge, skills, and confidence in managing child's care. Items are scored using a 4-point Likert scale (1 = disagree strongly; 4 = agree strongly). Higher scores correspond to higher activation.
Time frame: 6, 12 months
Plan to share: Yes — Individual participant data (IPD) with all potentially identifying information removed will be shared. 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. IPD to be shared includes individual level survey and questionnaire data, coded interview data, and coded data abstracted from the child's medical record, Individualized Education Plan (if applicable), domain specific Early Childhood Special Education therapies, educational placement and supports.
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago