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NCT07227974 · ClinicalTrials.gov registry record · NA
Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Developmental Delays
A NA study, sponsored by Northwestern University.
- Recruiting
- Registry status
- NA
- Development phase
- 1,269
- Enrollment target
NCT07227974: Recruiting NA study, sponsored by Northwestern University.
NCT07227974 is a NA study that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 1,269 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07227974, a NA study, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,269 participants
- Enrollment target
Study 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.
Primary Outcome
The Responsive Strategy Use (RSU) Rating Scale will be used to measure caregivers' use of responsive strategies during a naturalistic, caregiver-child interaction. Items on the RSU Rating Scale are rated on a 4-point Likert Scale (0 = Rarely/Never, 3 = Consistently) and averaged to yield the RSU Total Score (Min = 0, Max = 3), with higher scores reflecting a higher frequency of responsive strategy use.
Interventions
- BEHAVIORAL Therapist-Delivered Early Intervention Approach
- BEHAVIORAL Caregiver Coaching Early Intervention Approach
- BEHAVIORAL Parents Taking Action
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,269 participants |
| Start Date | 2026-02-16 |
| Est. Completion | 2030-06 |
| Phase | NA |
What NCT07227974 shows while recruiting
NCT07227974 is an interventional study that assigns participants to a tested intervention. Its 1,269 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 3 interventions - of which Therapist-Delivered Early Intervention Approach is the first listed.
NCT07227974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07227974 about?
NCT07227974 is a clinical study titled "Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Developmental Delays". 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...
What is the current status of trial NCT07227974?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,269 participants. The study started on 2026-02-16. Estimated completion is 2030-06.
What interventions are being tested in trial NCT07227974?
The interventions under investigation include: Therapist-Delivered Early Intervention Approach (BEHAVIORAL), Caregiver Coaching Early Intervention Approach (BEHAVIORAL), Parents Taking Action (BEHAVIORAL).
Who is sponsoring clinical trial NCT07227974?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07227974's enrollment target sits among peer trials
1,269 79th of 2000 higher than 1,922 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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