Developmental DelaysNCT07227974
Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Developmental Delays
A study testing Therapist-Delivered Early Intervention Approach, Caregiver Coaching Early Intervention Approach and Parents Taking Action in people with Developmental Delays, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 32 months
- Conditions the study is for
- Developmental Delays
- What is being tested?
- Therapist-Delivered Early Intervention Approach, Caregiver Coaching Early Intervention Approach and Parents Taking Action
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,269 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2026to Jun 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 32 months
- All sexes
- No healthy volunteers
- Child
Child Inclusion Criteria:
- At least 12 months old
- Functional communication skills at an age equivalent of at least 6 months
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Evanston, Illinois, 60201
Laura Sudec, Masters, laura.sudec@northwestern.edu
Megan Roberts, PhD
About this study
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:
Read more
- Therapist Delivered EI: For 28 weeks, the child's speech therapist will work directly with the child to support their communication.
- Caregiver Coaching EI: For 28 weeks, the child's speech therapist will coach the caregiver on how to support their child's communication.
- 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.
Read the detailed description
High-quality Early Intervention (EI) during the first three years of life, a period of heightened neuroplasticity, is critical to improving outcomes for children with developmental disabilities (DD). There are two EI approaches that may be effective for supporting child communication and improving family outcomes: 1) caregiver coaching, in which the EI therapist teaches the caregiver strategies to help their child's communication, and 2) caregiver psychoeducation, in which a peer mentor teaches the caregiver about skills and resources that are helpful in supporting their child and family.
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:
- Therapist Delivered EI: For 28 weeks, the child's speech therapist will work directly with the child to support their communication.
- Caregiver Coaching EI: For 28 weeks, the child's speech therapist will coach the caregiver on how to support their child's communication.
- 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 use of responsive strategies, 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 use of responsive strategies) 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
- Developmental Delays
- Being tested
- Therapist-Delivered Early Intervention Approach, Caregiver Coaching Early Intervention Approach, Parents Taking Action
- Keywords
- Developmental Disabilities, Language Delay, Caregiver Coaching, Caregiver Responsiveness, Early Intervention, Pragmatic Clinical Trial, Communication, Speech-Language Pathology, Patient-Centered Outcomes Research
- Medical subject headings
- Developmental Disabilities, Language Development Disorders, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist-Delivered Early Intervention ApproachBehavioural
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 ApproachBehavioural
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 ActionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapist-Delivered Early Intervention Approach | Active comparator | For 28 weeks, this arm will receive the therapist-delivered early intervention approach. Receives: Behavioral: Therapist-Delivered Early Intervention Approach |
| Caregiver Coaching Early Intervention Approach | Experimental | For 28 weeks, this arm will receive the caregiver coaching early intervention approach. Receives: Behavioral: Caregiver Coaching Early Intervention Approach |
| Combined Early Intervention Approach + Parents Taking Action | Experimental | 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. Receives: Behavioral: Therapist-Delivered Early Intervention Approach; Behavioral: Caregiver Coaching Early Intervention Approach; Behavioral: Parents Taking Action |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responsive Strategy Use (RSU) Rating Scale
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.
Measured: Week 14, Week 28
Family Outcomes Survey - Revised
The Family Outcomes Survey-Revised is a 24-item informant-report questionnaire that assesses caregivers' understanding, confidence, and ability to support their child's needs. The Family Outcomes Total Score (Min = 24, Max = 120) reflects the caregiver's capacity to support their child's needs, with higher scores indicating greater capacity.
Measured: Week 14, Week 28
Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP)
The Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP) is a structured, norm-referenced, observational measure of child communication. The assessment is scored for 20 items across 7 domains (i.e., Emotion and Eye Gaze, Communication, Gestures, Sounds, Words, Understanding, Object Use). The weighted raw scores for each of the 7 domains are grouped into 3 clusters (social, speech, and symbolic) and combined into a total raw score (min = 0; max = 113). Higher scores indicate better skills.
Measured: Week 28
Secondary outcomes (3)
Session Attendance
Session attendance will be documented in weekly session logs completed by interventionists and summarized as the percentage of planned intervention sessions attended by each family (Min = 0%, Max = 100%).
Measured: Week 1 to Week 28
Intervention Fidelity Checklist
The Intervention Fidelity Checklist is a rating scale assessing adherence to the intervention protocol. Items on the checklist correspond to the core elements of the respective intervention protocol and are scored based on specific behavioral criteria. The Intervention Fidelity Checklist will be scored on a randomly selected 20% of intervention sessions per participant. Scores will be averaged across sessions to yield an average intervention quality score (Min = 0, Max = 100), with higher scores indicating higher intervention quality.
Measured: Week 1 to Week 28
Framework for Reporting Adaptations and Modifications (FRAME)
The Framework for Reporting Adaptations and Modifications (FRAME) will be used to document intervention adaptations. Adaptations will be documented through intervention session logs and direct observations of intervention sessions. These data will yield the total number of adaptations (Min = 0, Max = NA).
Measured: Week 1 to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start16 Feb 2026
- Primary completionMar 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DelaysStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a three-arm randomized controlled trial designed to compare the effectiveness of different approaches to Early Intervention (EI) service delivery for toddlers with speech and communication delays. Participants will be randomly assigned to one of three intervention models 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., use of responsive strategies 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,269 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Megan Roberts, Northwestern University
- Investigators
- Megan Roberts, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227974
- Sponsor's protocol ID
- BPS-2024C1-38924
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in any publication arising from this trial will be made publicly available via the Dryad repository. The shared dataset will include all variables necessary to reproduce the published findings, including treatment assignment, participant demographics, baseline characteristics, and outcome measures. All data will be de-identified in accordance with HIPAA standards and institutional policies to protect participant confidentiality. Data will be uploaded to Dryad after publication of the primary results, and will be freely accessible to qualified researchers without restriction. A corresponding DOI will be provided in publications to facilitate data access and citation.