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

Developmental Delay Clinical Trial

— PreM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145659
• Other study ID #: 2023-1361
• Secondary ID: R01NR021155
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: January 2029

Study information

• Verified date: April 2024
• Source: University of Illinois at Chicago
• Contact: Reshma Shah, MD, MPH
• Phone: 3125235030
• Email: reshmamd[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: January 2029
• Est. primary completion date: September 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Developmental Delay

Intervention

Behavioral:
• Preschool and Me
Utilizes patient navigation services and a medical-educational care plan to support linkages between medical and educational systems

Locations

Country	Name	City	State
United States	UI Health	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	6, 12 months
Other	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.	6, 12 months
Primary	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	Up to 12 months
Primary	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	Up to 12 months
Primary	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.	Up to 12 months
Primary	Percent of children who complete each step of IEP process	Percent of children who complete each step of IEP process	up to 12 months
Secondary	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.	Baseline, 12 month follow up
Secondary	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.	Baseline, 12 month follow up
Secondary	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.	Baseline, 12 month follow up
Secondary	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.	Baseline, 12 month follow up
Secondary	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.	Baseline, 12 month follow up
Secondary	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.	Up to 6 months
Secondary	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	Up to 6 months
Secondary	Adoption	Ratio of number of Primary Care Providers (PCPs) who referred to Preschool and Me (PreM) to total number of PCPs	up to 6 months
Secondary	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	up to 6 months
Secondary	Penetration	Ratio of number of caregivers contacted by Patient Navigator (PN) to number of caregivers referred	up to 6 months
Secondary	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	up to 6 months
Secondary	Fidelity	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
Secondary	Cost	Time estimates of training and supervision; Per family time estimates associated with PN activities	up to 6 months
Secondary	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).	Baseline and 12 months