Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-02-02 @ 8:59 AM
Study NCT ID:
NCT06347666
Status:
TERMINATED
Last Update Posted:
2025-04-17
First Post:
2024-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coaching in Early Development Project
Sponsor:
Rush University Medical Center
Organization:
Study Overview
Official Title:
Equity-focused Implementation of Caregiver Coaching for Unhoused Children At-risk for Developmental Delay
Status:
TERMINATED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding was terminated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Among young children, homelessness is an independent predictor of child developmental delay and disability, and children experiencing homelessness (CEH) are 2-4x more likely to demonstrate developmental delays compared to housed children. The purpose of this project is to evaluate an evidence-based model of caregiver coaching for CEH that screen positive for developmental delay. The investigators will also evaluate the societal costs of the program, its preliminary efficacy, and the acceptability among caregivers and shelter staff.
Detailed Description:
Over 2.5 million children experience homelessness (CEH) in a given year and housing intersects with inequities due to race and disability. Among young children, homelessness is an independent predictor of child developmental delay and disability, and CEH are 2-4x more likely to demonstrate developmental delays compared to housed children. Caregiver coaching is an evidence-based and effective behavioral therapy method to support child development and has been recommended by the American Academy of Pediatrics for adoption across all early intervention (EI) systems. EI is mandated by states under the Individuals with Disabilities Education Act (IDEA) Part C and provides behavioral therapy for all children ages 0-3 years that show developmental delay. Within EI, caregiver coaching is delivered is delivered in families' homes, and therefore has limited evaluation of implementation in shelters. In ongoing pilot work, in collaboration with shelter-based primary care, 70% of CEH screened positive for developmental delay, yet no child received caregiver coaching through EI. Therefore, the objective of this proposal is to use a Type II Hybrid Trial to investigate how implementation strategies influence uptake of shelter-based caregiver coaching and subsequent child outcomes. The proposed study will use implementation research as a guide to evaluate our team's implementation of caregiver coaching from an equity lens among a population that consistently lacks access to evidence-based interventions to improve children's developmental trajectories. Specifically, the investigators will 1) Evaluate implementation of a 12-week shelter-based caregiver coaching intervention on caregiver attendance and fidelity (i.e., adherence) among CEH with delay ages compared to statewide equity metrics; 2) Evaluate the societal costs of implementing a 12-week shelter-based caregiver coaching intervention; 3) Investigate facilitators and barriers related to attendance and fidelity of a 12-week coaching intervention among caregivers of CEH and shelter staff; 4) Explore the efficacy of the 12-week coaching intervention on caregiver and child outcomes. While disparities in access to evidence-based developmental care for CEH is documented, the investigators will identify how strategies that promote equity in access result in caregiver uptake and costs. By evaluating stakeholder feedback of an evidence-based intervention not yet tested in shelters, the investigators can integrate changes to the model for future trials. The impact will be on prioritizing ways to promote uptake of tailored developmental interventions for children most in need, ultimately contributing to evidence to share with families, shelters, and policymakers to create sustainable models of care.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: