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

Summary

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

• Developmental Delays

Interventions

BEHAVIORAL

Therapist-Delivered Early Intervention Approach

The therapist-delivered early intervention approach will occur during the child's weekly, hour-long early intervention (EI) sessions. During the sessions, the child's EI speech-language pathologist (SLP) will use responsive strategies directly with the child. Responsive strategies focus on noticing the child's communication and responding with language related to their focus of attention. The SLP will not coach the caregiver during the sessions.

BEHAVIORAL

Caregiver Coaching Early Intervention Approach

The caregiver-coaching early intervention approach will occur during the child's weekly, hour-long early intervention (EI) sessions. During the sessions, the child's EI speech-language pathologist (SLP) will coach the caregiver to use responsive strategies with their child. Responsive strategies focus on noticing the child's communication and responding with language related to their focus of attention.

BEHAVIORAL

Parents Taking Action

Parents Taking Action (PTA) will be delivered during weekly, one-hour virtual sessions with the caregiver, separate from the child's early intervention (EI) sessions. PTA is a psychoeducation program implemented by a peer mentor (i.e., a culturally-matched caregiver of a child with a developmental disability). During the sessions, the peer mentor will provide information and guidance on a range of topics (e.g., child development, early intervention systems, special education rights/resources, and advocacy) following a structured curriculum.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Northwestern University

  lead OTHER

Principal Investigators

• Megan Roberts, PhD · Northwestern University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

31 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-16

Primary Completion

2030-03-31

Completion

2030-06-30

Countries

• United States

Study Locations