RecruitingNot Applicable

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

United States1,269 participantsStarted 2026-02-16

Plain-language 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.

Who can participate

Age range12 Months – 31 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Child Inclusion Criteria: * At least 12 months old * 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

What they're measuring

Responsive Strategy Use (RSU) Rating Scale

Timeframe: Week 14, Week 28

Family Outcomes Survey - Revised

Timeframe: Week 14, Week 28

Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP)

Timeframe: Week 28

Trial details

NCT IDNCT07227974

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-03

Contact for this trial

Laura Sudec, Masters

1-847-491-3183 laura.sudec@northwestern.edu