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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Developmental Delay

Intervention / Treatment
-----------------
* Behavioral: Preschool and Me


Participation Criteria
=================
Eligibility Criteria
-----------------
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., 36-59 months of age by September 1 of current school year); 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); screens positive on the Survey of Wellbeing of Young Children, a validated screening instrument for DD available in English and Spanish; 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.

Ages Eligible for Study
-----------------
Minimum Age: 36 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Linkage Model<br>Preschool and Me intervention | Behavioral: Preschool and Me<br>* Utilizes patient navigation services and a medical-educational care plan to support linkages between medical and educational systems<br>|
| No Intervention: Treatment as Usual<br>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 | Increased access to early childhood special education (ECSE) as measured by enrollment in early childhood education program | Up to 12 months | 
| Percent of children who receive ECSE-based therapies | Increased access to early childhood special education (ECSE) services as measured by receipt of ECSE-based services | Up to 12 months | 
| Timeliness of ECSE services | Calculate the time (number of days) from a child's 3rd birthday to 1) date of ECSE request; 2) date of IEP eligibility meeting; 3) attendance at preschool (first day); and 4) start date of first ECSE-based therapy for those found eligible. | Up to 12 months | 
| Percent of children who complete each step of ECSE process | Percent of children who complete each step of ECSE process | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child quality of life | Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is a measure of communication, daily living skills, and socialization skils which is administered in a semi-structured parent interview format. Items assess the individual's behavior in these domains and are rated according to the frequency with which behaviors are performed without help or prompting (i.e., Never, Sometimes or Usually). The raw scores are converted to standard scores (mean = 100, SD = 15; range 40 to 160), and higher scores indicate better adaptive functioning. | Baseline, 12 month follow up | 
| Child sleep habits | Exploratory outcome assessing regulation of sleep using Family Inventory of Sleep Habit (FISH). The FISH is a 12-item survey of sleep habits which is scored on a 5-point scale. A higher score indicates better sleep hygiene. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | up to 6 months | 
| Penetration | Ratio of number of caregivers contacted by Patient Navigator (PN) to number of caregivers referred | 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 | 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 | up to 6 months | 
| Cost | Time estimates of training and supervision; Per family time estimates associated with PN activities | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary care, implementation, linkage