Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Dev… (NCT07227974) | Clinical Trial Compass
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 range
12 Months – 31 Months
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing different early intervention approaches for toddlers with developmental delays — can you help me understand what the main differences between these approaches are, and which one might be the best fit for my child based on their specific needs?
2One of the things being measured is how parents use 'responsive strategies' with their child — does that mean a big part of this involves training me as a caregiver, and how much time and practice would that realistically require from our family each week?
3Since this study is listed as Phase NA, which often means it's comparing existing approaches rather than testing a brand-new treatment, does that change how you think about the known safety and effectiveness of the interventions being studied?
4The trial is measuring communication using something called the CSBS-DP — can you explain what that assessment looks like for a toddler, and how the results from it would actually be used to track my child's progress during the study?
5Before considering enrolling my child in this trial, are there standard early intervention services we should be accessing right now through programs like Early Intervention or an IEP, and would participating in this study work alongside those services or potentially conflict with them?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Responsive Strategy Use (RSU) Rating Scale
Timeframe: Week 14, Week 28
2
Family Outcomes Survey - Revised
Timeframe: Week 14, Week 28
3
Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP)