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NCT07227974
Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Developmental Delays
Conditions: Developmental Delays
Sex: All
Ages: 12 Months – 31 Months
Healthy volunteers: No
Phase: NA
Enrollment: 1269
Sponsor: Northwestern University
Location: Northwestern University Evanston Illinois
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT07227974). StuddyBuddy aggregates publicly available trial information.