Coaching in Early Development Project

Developmental Delay Clinical Trial

Official title:

Equity-focused Implementation of Caregiver Coaching for Unhoused Children At-risk for Developmental Delay

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06347666
• Other study ID #: 23082905
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2024
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: Rush University Medical Center
• Contact: Lauren M Little, PhD
• Phone: 312.942.1759
• Email: lauren_little[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. We will also evaluate the societal costs of the program, its preliminary efficacy, and the acceptability among caregivers and shelter staff.

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 equity focused implementation strategies influence uptake of shelter-based caregiver coaching and subsequent child outcomes. The proposed study will use the equity focused implementation research for health programs framework 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. Public health critical race praxis will also guide our work to maintain community engagement and critical self-reflection to illuminate and combat racial barriers to health equity. Specifically, we 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, we 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, we 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 6 Years

Eligibility

Inclusion Criteria:

• Children must be unhoused or experience housing instability and screen positive for developmental delay

Exclusion Criteria:

• Children are excluded if they are receiving more than 1 hour/week of early intervention

Related Conditions & MeSH terms

• Developmental Delay

Intervention

Behavioral:
• Caregiver coaching
Speech language pathologists will meet with caregivers to talk through strategies to promote child development.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parenting Sense of Competence Scale	Self-report of satisfaction and efficacy associated with parenting.	baseline and post-12 week intervention
Primary	Parenting Stress Scale	Self-report of stressors associated with parenting	baseline and post-12 week intervention
Secondary	Mullen Scales of Early Learning	Behavioral assessment of overall child development	baseline and post-12 week intervention
Secondary	Maternal Behavior Responsivity Scale	Observational assessment of maternal responsivity	baseline and post-12 week intervention