Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06145659

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

36 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UI Health

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Parent-child dyads who meet inclusion criteria will be enrolled.

Child inclusion criteria are:

  • 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.

Exclusion criteria

if inclusion criteria is met, no other exclusion criteria will be applied.

Parent inclusion criteria are:

  • aged18 years or older;
  • lives in Chicago;
  • speaks English or Spanish;
  • a legal guardian of a child who meets inclusion criteria.

Treatment and study plan

Preschool and Me

Behavioral

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

Primary outcomes

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

    Time frame: Up to 12 months

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

  2. Percent of children who receive school-based therapies

    Time frame: Up to 12 months

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

  3. Timeliness of ECSE services

    Time frame: Up to 12 months

    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.

  4. Percent of children who complete each step of IEP process

    Time frame: up to 12 months

    Percent of children who complete each step of IEP process

Secondary outcomes

  1. Child quality of life

    Time frame: Baseline, 12 month follow up

    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.

  2. Child sleep habits

    Time frame: Baseline, 12 month follow up

    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.

  3. Parenting stress

    Time frame: Baseline, 12 month follow up

    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.

  4. Family Functioning

    Time frame: Baseline, 12 month follow up

    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.

  5. Family-centered care self-assessment tool

    Time frame: Baseline, 12 month follow up

    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.

  6. Satisfaction with the Interpersonal Relationship with the Navigator (PSN-I)

    Time frame: Up to 6 months

    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.

  7. Acceptability of Intervention Measure

    Time frame: Up to 6 months

    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

  8. Adoption

    Time frame: up to 6 months

    Ratio of number of Primary Care Providers (PCPs) who referred to Preschool and Me (PreM) to total number of PCPs

  9. Intervention Appropriateness Measure (IAM)

    Time frame: up to 6 months

    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

  10. Penetration

    Time frame: up to 6 months

    Ratio of number of caregivers contacted by Patient Navigator (PN) to number of caregivers referred

  11. Feasibility of Intervention Measure

    Time frame: up to 6 months

    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

  12. Fidelity

    Time frame: up to 6 months

    Per family ratio of number of PN activities conducted to number of activities that should be conducted according to protocol/job aid

  13. Cost

    Time frame: up to 6 months

    Time estimates of training and supervision; Per family time estimates associated with PN activities

  14. Parental Quality of Life

    Time frame: Baseline and 12 months

    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).

Other outcomes

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

    Time frame: 6, 12 months

    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.

  2. Parent Patient Activation Measure Parent Patient Activation Measure Parent Patient Activation Measure

    Time frame: 6, 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • National Institutes of Health (NIH)

Registry information

Official study title

Educational-Clinical Linkage to Improve Health Equity for Children With Developmental Delays and Disabilities From Marginalized Communities

Acronym: PreM

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Nov 24, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.