- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06145659
School-based Support for Pre-school Aged Children With Developmental Disabilities and Delays (PreM)
April 24, 2024 updated by: University of Illinois at Chicago
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
320
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reshma Shah, MD, MPH
- Phone Number: 3125235030
- Email: reshmamd@uic.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- UI Health
-
Contact:
- Reshma Shah, MD, MPH
- Email: reshmamd@uic.edu
-
Contact:
- Tina Schuh, MPH
- Email: tschuh2@uic.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Linkage Model
Preschool and Me intervention
|
Utilizes patient navigation services and a medical-educational care plan to support linkages between medical and educational systems
|
No Intervention: Treatment as Usual
Preschool and Me intervention is not used
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 12 months
|
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
|
Up to 12 months
|
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.
|
Up to 12 months
|
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
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 12 month follow up
|
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.
|
Baseline, 12 month follow up
|
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.
|
Baseline, 12 month follow up
|
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.
|
Baseline, 12 month follow up
|
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.
|
Baseline, 12 month follow up
|
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.
|
Up to 6 months
|
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
|
Up to 6 months
|
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
|
up to 6 months
|
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
|
up to 6 months
|
Penetration
Time Frame: up to 6 months
|
Ratio of number of caregivers contacted by Patient Navigator (PN) to number of caregivers referred
|
up to 6 months
|
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
|
up to 6 months
|
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
|
up to 6 months
|
Cost
Time Frame: up to 6 months
|
Time estimates of training and supervision; Per family time estimates associated with PN activities
|
up to 6 months
|
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).
|
Baseline and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6, 12 months
|
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.
|
6, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Reshma Shah, MD, MPH, University of Illinois at Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2024
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
January 1, 2029
Study Registration Dates
First Submitted
November 7, 2023
First Submitted That Met QC Criteria
November 16, 2023
First Posted (Actual)
November 24, 2023
Study Record Updates
Last Update Posted (Estimated)
April 26, 2024
Last Update Submitted That Met QC Criteria
April 24, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023-1361
- R01NR021155 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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