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Clinical trial Recruiting at 1 site Interventional Ages 12 Months to 32 Months

Comparing three ways to help toddlers with developmental delays learn to communicate

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

Run by Northwestern University · NCT07227974 · Data updated 2026-11-12

We are testing three different early intervention approaches to see which helps toddlers with developmental delays improve their communication the most.

Quick facts

Study typeInterventional
Ages12 Months to 32 Months
SexAll
Enrollment1269 (estimated)
SponsorNorthwestern University
Academic / other
Locations1 site (Evanston, Illinois)
StatusRecruiting
StartedFebruary 16, 2026
Main results expectedMarch 2030
Study endsJune 2030
Registry record updatedOctober 21, 2026
Trial IDNCT07227974 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are toddlers at least 12 months old enrolled in the Illinois Early Intervention system with at least seven months of EI eligibility remaining, new to the speech-language pathologist's caseload, planning to receive about one hour per week of speech therapy, and with caregivers available for weekly sessions who self-identify as Black, Latine, or white.

Probably not a fit

Children exposed to a language other than English or Spanish more than 10% of the time, caregivers under 18, families outside the Illinois EI system, or those unable to participate in weekly sessions are unlikely to be eligible or to benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial will enroll about 1,269 toddlers receiving community-based Early Intervention services in Illinois and assign caregiver-child dyads to one of three approaches: therapist-delivered intervention for 28 weeks, caregiver coaching for 28 weeks, or a combined approach with 14 weeks of a parent-led education program followed by 14 weeks of therapist coaching. Services are delivered through participating EI therapists' existing caseloads and take place in the home or private spaces outside the home. Outcome measures will track child communication, caregiver responsiveness, family outcomes, and implementation measures such as acceptability and feasibility. The goal is to determine which delivery approach works best for which families and to understand how therapists implement these interventions in real-world settings.

Why it matters

Potential benefit: If successful, the results could identify the most effective way to deliver early intervention so more toddlers improve communication and families receive better-targeted support.

How similar studies have gone: Prior research supports caregiver coaching improving child communication and shows mixed results for psychoeducation, while large randomized, community-based comparisons of these approaches remain relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Northwestern University
    Evanston, Illinois, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.