Coaching in Early Development Project

NCT06347666 | Terminated

• 1 other identifier: 23082905
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Delay

Outcome Measures

Primary Outcomes (2)

• Parenting Sense of Competence Scale

  Self-report of satisfaction and efficacy associated with parenting. Higher scores mean that a respondent has higher parenting sense of competence. Scores range from 6-102.

  baseline and post-12 week intervention

• Parenting Stress Scale

  Self-report of stressors associated with parenting. Higher scores mean higher parenting stress and scores range from 18-90.

  baseline and post-12 week intervention

Secondary Outcomes (2)

• Mullen Scales of Early Learning

  baseline and post-12 week intervention

• Maternal Behavior Responsivity Scale

  baseline and post-12 week intervention

Study Arms (1)

Caregiver Coaching

EXPERIMENTAL

In this arm, participants receive a caregiver coaching intervention. In the intervention, a speech language pathologist offers strategies to support child development.

Behavioral: Caregiver coaching

Interventions

Caregiver coaching BEHAVIORAL

Speech language pathologists will meet with caregivers to talk through strategies to promote child development.

Caregiver Coaching

Eligibility Criteria

• Age: 12 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Lauren M Little, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group will receive the caregiver coaching intervention.

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start: January 12, 2024
• Primary Completion: March 26, 2025
• Study Completion: March 26, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)