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Developmental DelayPreMNCT06145659

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

A study testing Preschool and Me in people with Developmental Delay, run by University of Illinois at Chicago at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 36 months and olderHealthy volunteers can take part
Conditions the study is for
Developmental Delay
What is being tested?
Preschool and Me
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
1 siteUnited States
Study dates
25 Mar 2024to 1 Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 36 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UI Health

    Chicago, Illinois, 60612

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Preschool and Me
Keywords
primary care, implementation, linkage
Medical subject headings
Learning Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preschool and MeBehavioural

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

Study groups in NCT06145659
Study groupRoleWhat they receive
Linkage ModelExperimentalPreschool and Me intervention
Receives: Behavioral: Preschool and Me
Treatment as UsualNo interventionPreschool and Me intervention is not used

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 12 months

  2. 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

    Measured: Up to 12 months

  3. 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.

    Measured: Up to 12 months

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

    Percent of children who complete each step of IEP process

    Measured: up to 12 months

Secondary outcomes (14)

  1. 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.

    Measured: Baseline, 12 month follow up

  2. 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.

    Measured: Baseline, 12 month follow up

  3. 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.

    Measured: Baseline, 12 month follow up

  4. 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.

    Measured: Baseline, 12 month follow up

  5. 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.

    Measured: Baseline, 12 month follow up

  6. 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.

    Measured: Up to 6 months

  7. 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

    Measured: Up to 6 months

  8. Adoption

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

    Measured: up to 6 months

  9. 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

    Measured: up to 6 months

  10. Penetration

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

    Measured: up to 6 months

  11. 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

    Measured: up to 6 months

  12. Fidelity

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

    Measured: up to 6 months

  13. Cost

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

    Measured: up to 6 months

  14. 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).

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2023
  2. Study start25 Mar 2024
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06145659
Sponsor's protocol ID
2023-1361
Other IDs
R01NR021155
Acronym
PreM
Status last verified
Jul 2026
First submitted
7 Nov 2023
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Preschool and Me in people with Developmental Delay, run by University of Illinois at Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of children who enroll in a designated early childhood special education (ECSE) program or Chicago Public School (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06145659.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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