School-based Support for Pre-school Aged Children With Developmental Disabilities and Delays
- Conditions
- Developmental Delay
- Interventions
- Behavioral: Preschool and Me
- Registration Number
- NCT06145659
- Lead Sponsor
- University of Illinois at Chicago
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
Not provided
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Linkage Model Preschool and Me Preschool and Me intervention
- Primary Outcome Measures
Name Time Method Percent of children who complete each step of IEP process up to 12 months Percent of children who complete each step of IEP process
Timeliness of ECSE services 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.
Percent of children who enroll in a designated early childhood special education (ECSE) program or Chicago Public School 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
Percent of children who receive school-based therapies Up to 12 months Increased access to early childhood special education (ECSE) services as measured by receipt of school-based services
- Secondary Outcome Measures
Name Time Method Penetration up to 6 months Ratio of number of caregivers contacted by Patient Navigator (PN) to number of caregivers referred
Fidelity 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
Intervention Appropriateness Measure (IAM) 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
Acceptability of Intervention Measure 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
Child sleep habits 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.
Cost up to 6 months Time estimates of training and supervision; Per family time estimates associated with PN activities
Parental Quality of Life 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).
Parenting stress 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.
Family Functioning 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.
Family-centered care self-assessment tool 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.
Feasibility of Intervention Measure 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
Child quality of life 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.
Satisfaction with the Interpersonal Relationship with the Navigator (PSN-I) 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.
Adoption up to 6 months Ratio of number of Primary Care Providers (PCPs) who referred to Preschool and Me (PreM) to total number of PCPs
Trial Locations
- Locations (1)
UI Health
🇺🇸Chicago, Illinois, United States