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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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)