RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Northwestern University • ClinicalTrials.gov ID: NCT07227974

Registry updated: 2026-10-21

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Therapist-Delivered Early Intervention Approach (Behavioral)
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.
Caregiver Coaching Early Intervention Approach (Behavioral)
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.
Parents Taking Action (Behavioral)
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.

Eligibility criteria

Child Inclusion Criteria: * At least 12 months old * Functional communication skills at an age equivalent of at least 6 months * At least 7 months of Early Intervention (EI) service eligibility remaining * Enrolled in the Illinois EI system and is new to the speech-language pathologist's (SLP's) caseload (i.e., no prior EI speech-language therapy experience with the SLP) * Plans to receive one hour of speech-language therapy per week in the home or in a private space outside of the home Child Exclusion Criteria: \- Exposed to a language other than English or Spanish more than 10% of the time Caregiver Inclusion Criteria: * The child's parent, legal guardian, or other family member * Self-identifies as Black, Latine (Hispanic), or white * Available to participate in weekly EI sessions and study assessments Caregiver Exclusion Criteria * Younger than 18 years old at enrollment * Uses a language other than English or Spanish during their interactions with the child more than 10% of the time

Conditions

Developmental Delays

Locations

Northwestern University — Evanston, Illinois, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment