Empower EI: Comparing Early Intervention Approaches to Improve Communication in Toddlers With Developmental Delays

NCT07227974 | Recruiting

• 1 other identifier: BPS-2024C1-38924
• Study Type: interventional
• Target: 1,269
• Locations: 1 country
• Sites: 1

Brief 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. 1.Therapist Delivered EI: For 28 weeks, the child's speech therapist will work directly with the child to support their communication.
2. 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. 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.

Conditions

Developmental Delays

Keywords

Developmental Disabilities; Language Delay; Caregiver Coaching; Caregiver Responsiveness; Early Intervention; Pragmatic Clinical Trial; Communication; Speech-Language Pathology; Patient-Centered Outcomes Research

Outcome Measures

Primary Outcomes (3)

• 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 5-point Likert Scale (1 = Rarely/Never, 5 = Consistently) and averaged to yield the RSU Total Score (Min = 1, Max = 5), with higher scores reflecting a higher frequency of responsive strategy use.

  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.

  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.

  Week 28

Secondary Outcomes (3)

• Session Attendance

  Week 1 to Week 28

• Intervention Fidelity Checklist

  Week 1 to Week 28

• Framework for Reporting Adaptations and Modifications (FRAME)

  Week 1 to Week 28

Other Outcomes (1)

• Early Intervention Program Satisfaction Scale

  Week 14, Week 28

Study Arms (3)

Therapist-Delivered Early Intervention Approach

ACTIVE COMPARATOR

For 28 weeks, this arm will receive the therapist-delivered early intervention approach.

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.

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.

Behavioral: Therapist-Delivered Early Intervention Approach; Behavioral: Caregiver Coaching Early Intervention Approach; Behavioral: Parents Taking Action

Interventions

Therapist-Delivered Early Intervention Approach BEHAVIORAL

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.

Combined Early Intervention Approach + Parents Taking Action; Therapist-Delivered Early Intervention Approach

Caregiver Coaching Early Intervention Approach BEHAVIORAL

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.

Caregiver Coaching Early Intervention Approach; Combined Early Intervention Approach + Parents Taking Action

Parents Taking Action BEHAVIORAL

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.

Combined Early Intervention Approach + Parents Taking Action

Eligibility Criteria

• Age: 12 Months - 31 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- Exposed to a language other than English or Spanish more than 10% of the time
• 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.
• 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

Sponsors & Collaborators

• Northwestern University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Northwestern University

Evanston, Illinois, 60201, United States

RECRUITING

MeSH Terms

Conditions

Developmental Disabilities; Language Development Disorders; Communication

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Megan Roberts, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Sudec, Masters

CONTACT

1-847-491-3183; laura.sudec@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2025
• First Posted: November 13, 2025
• Study Start: February 16, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will be uploaded to the Dryad data repository on November 1st, 2030 and remain there indefinitely.
• Access Criteria: De-identified individual participant data (IPD) and supporting documentation (e.g., data dictionaries, survey instruments, codebooks) will be publicly available to any researcher or member of the public. All data will be uploaded to the Dryad Digital Repository, where users can freely access and download the datasets. No special request or application will be required to access the IPD. The data will be shared in a de-identified format to protect participant privacy, and users will be able to access the IPD along with associated documentation necessary to understand and use the data for secondary analyses or replication studies.

Locations

US (1)