Actively Recruiting

Phase Not Applicable
Age: 12Months - 31Months
All Genders
NCT07227974

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

Led by Northwestern University · Updated on 2026-04-29

1269

Participants Needed

1

Research Sites

223 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Months - 31Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child is at least 12 months old
  • Child has at least 7 months of Early Intervention service eligibility remaining
  • Child is enrolled in the Illinois Early Intervention system and new to the speech-language pathologist's caseload
  • Child plans to receive one hour of speech-language therapy weekly at home or a private space
  • Caregiver is the child's parent, legal guardian, or other family member
  • Caregiver self-identifies as Black, Latine (Hispanic), or white
  • Caregiver is available to participate in weekly Early Intervention sessions and study assessments
Not Eligible

You will not qualify if you...

  • Child is exposed to a language other than English or Spanish more than 10% of the time
  • Caregiver is younger than 18 years old at enrollment
  • Caregiver uses a language other than English or Spanish during interactions with the child more than 10% of the time

AI-Screening

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Trial Site Locations

Total: 1 location

1

Northwestern University

Evanston, Illinois, United States, 60201

Actively Recruiting

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Research Team

L

Laura Sudec, Masters

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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