Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Developmental Delays

This study is testing three ways to deliver Early Intervention (EI) services for toddlers with developmental disabilities (DD). Children enrolled in EI speech therapy will receive one of three approaches: 1. Therapist Delivered EI: For 28 weeks, the child's speech therapist will work directly with the child to support their communication. 2. Caregiver Coaching EI: For 28 weeks, the child's speech therapist will coach the caregiver on how to support their child's communication. 3. Combined EI Approach + Parent-Led Education Program: For 14 weeks, the caregiver will take part in a parent-led education program while the speech therapist works directly with the child to support their communication. During the next 14 weeks, the speech therapist will coach the caregiver on how to support their child's communication. The goal of this study is to identify which approaches are most effective so that all families can benefit fully from EI services.

NCT Number	NCT07227974
Lead Sponsor	Northwestern University Collaborators: Patient-Centered Outcomes Research Institute
Conditions	Developmental Delays
Enrollment	1,269 participants
Start Date	2026-02-16
Primary Completion	2030-03 (estimated)
Study Completion	2030-06 (estimated)
Updated on ClinicalTrials.gov	2026-07-08