Comparing three ways to help toddlers with developmental delays learn to communicate
Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Developmental Delays
We are testing three different early intervention approaches to see which helps toddlers with developmental delays improve their communication the most.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1269 (estimated) |
| Ages | 12 Months to 31 Months |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Evanston, Illinois) |
| Trial ID | NCT07227974 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Evanston, Illinois
- Northwestern University — Evanston, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Megan Roberts, PhD — Northwestern University
- Study coordinator: Laura Sudec, Masters
- Email: laura.sudec@northwestern.edu
- Phone: 1-847-491-3183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.