Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Developmental Delays
NCT ID: NCT07227974
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
1269 participants
INTERVENTIONAL
2026-03-31
2030-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The aim of the current clinical trial is to determine which EI approaches are most effective, for which families, and why they are effective. This clinical trial also aims to investigate how therapists are delivering the interventions and to characterize the acceptability and feasibility of these interventions for use in real-world settings.
A total of 1,269 toddlers (approximately equal numbers of Black, Latine, and white children) will be enrolled across community-based EI sites. Families will be directly recruited from participating EI therapists' existing caseloads. Caregiver-child dyads will be randomly assigned to one of three groups:
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 + Parents Taking Action: For 14 weeks, the caregiver will take part in a parent-led education program (Parents Taking Action) 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.
Outcomes will assess both caregiver and child domains, including caregiver responsiveness, caregiver capacity to support the child's needs, and child social communication. The study will also examine moderators (e.g., race) and mediators (e.g., caregiver responsiveness) to identify for whom and why each approach is most effective.
A process evaluation will assess implementation fidelity (quality, dosage, adaptations) and explore how fidelity influences effectiveness outcomes. Feasibility, acceptability, and appropriateness of each approach will be evaluated through surveys and interviews with caregivers and EI therapists.
This study is among the first large-scale comparative effectiveness trials of early intervention approaches conducted in real-world EI settings. Findings will inform EI practices and guide caregivers, therapists, and policymakers in selecting interventions that best meet the needs and preferences of diverse families.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Each approach will be delivered over a 28-week period, with evaluations occurring at baseline, 14 and 28 weeks. The study will assess child outcomes (e.g., social communication) and caregiver outcomes (e.g., responsiveness and capacity to support their child's needs).
Participants will be randomized within their Early Intervention speech therapist, with stratification by race.
This randomized design enables direct comparisons across intervention models to determine which approaches are most effective for different families and to identify factors that influence their effectiveness.
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Therapist-Delivered Early Intervention Approach
For 28 weeks, this arm will receive the therapist-delivered early intervention approach.
Therapist-Delivered Early Intervention Approach
The therapist-delivered early intervention approach will occur during the child's weekly, hour-long early intervention (EI) sessions. During the sessions, the child's EI speech-language pathologist (SLP) will use responsive strategies directly with the child. Responsive strategies focus on noticing the child's communication and responding with language related to their focus of attention. The SLP will not coach the caregiver during the sessions.
Caregiver Coaching Early Intervention Approach
For 28 weeks, this arm will receive the caregiver coaching early intervention approach.
Caregiver Coaching Early Intervention Approach
The caregiver-coaching early intervention approach will occur during the child's weekly, hour-long early intervention (EI) sessions. During the sessions, the child's EI speech-language pathologist (SLP) will coach the caregiver to use responsive strategies with their child. Responsive strategies focus on noticing the child's communication and responding with language related to their focus of attention.
Combined Early Intervention Approach + Parents Taking Action
For the first 14 weeks, this arm will receive the therapist-delivered early intervention as well as Parents Taking Action. For the following 14 weeks, this arm will receive the caregiver coaching early intervention approach.
Therapist-Delivered Early Intervention Approach
The therapist-delivered early intervention approach will occur during the child's weekly, hour-long early intervention (EI) sessions. During the sessions, the child's EI speech-language pathologist (SLP) will use responsive strategies directly with the child. Responsive strategies focus on noticing the child's communication and responding with language related to their focus of attention. The SLP will not coach the caregiver during the sessions.
Caregiver Coaching Early Intervention Approach
The caregiver-coaching early intervention approach will occur during the child's weekly, hour-long early intervention (EI) sessions. During the sessions, the child's EI speech-language pathologist (SLP) will coach the caregiver to use responsive strategies with their child. Responsive strategies focus on noticing the child's communication and responding with language related to their focus of attention.
Parents Taking Action
Parents Taking Action (PTA) will be delivered during weekly, one-hour virtual sessions with the caregiver, separate from the child's early intervention (EI) sessions. PTA is a psychoeducation program implemented by a peer mentor (i.e., a culturally-matched caregiver of a child with a developmental disability). During the sessions, the peer mentor will provide information and guidance on a range of topics (e.g., child development, early intervention systems, special education rights/resources, and advocacy) following a structured curriculum.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Therapist-Delivered Early Intervention Approach
The therapist-delivered early intervention approach will occur during the child's weekly, hour-long early intervention (EI) sessions. During the sessions, the child's EI speech-language pathologist (SLP) will use responsive strategies directly with the child. Responsive strategies focus on noticing the child's communication and responding with language related to their focus of attention. The SLP will not coach the caregiver during the sessions.
Caregiver Coaching Early Intervention Approach
The caregiver-coaching early intervention approach will occur during the child's weekly, hour-long early intervention (EI) sessions. During the sessions, the child's EI speech-language pathologist (SLP) will coach the caregiver to use responsive strategies with their child. Responsive strategies focus on noticing the child's communication and responding with language related to their focus of attention.
Parents Taking Action
Parents Taking Action (PTA) will be delivered during weekly, one-hour virtual sessions with the caregiver, separate from the child's early intervention (EI) sessions. PTA is a psychoeducation program implemented by a peer mentor (i.e., a culturally-matched caregiver of a child with a developmental disability). During the sessions, the peer mentor will provide information and guidance on a range of topics (e.g., child development, early intervention systems, special education rights/resources, and advocacy) following a structured curriculum.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Enrolled in the Illinois Early Intervention system and newly eligible for speech-language therapy (i.e., no prior EI speech-language therapy experience).
* Plans to receive one hour of speech-language therapy per week in the home or in a private space outside of the home
* 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.
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
12 Months
28 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boston College
OTHER
North Carolina State University
OTHER
University of Texas at Austin
OTHER
Northwestern University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Megan Roberts
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Megan Roberts, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northwestern University
Evanston, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Laura Sudec, Masters
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BPS-2024C1-38924
Identifier Type: -
Identifier Source: org_study_id