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

Conditions

• Developmental Delays

Eligibility Criteria

Sex

ALL

Age

12 Months - 31 Months

Healthy Volunteers

Not accepted

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.
• 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.
• 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.

Study Details

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.

Key Dates

Start date

Feb 16, 2026

Status verified

Apr 2026

Primary completion

Mar 31, 2030

Completion

Jun 30, 2030

Study Design

Enrollment

1,269 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Therapist-Delivered Early Intervention Approach
  For 28 weeks, this arm will receive the therapist-delivered early intervention approach.
• Experimental: Caregiver Coaching Early Intervention Approach
  For 28 weeks, this arm will receive the caregiver coaching early intervention approach.
• Experimental: 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.

Primary Outcome Measure

Responsive Strategy Use (RSU) Rating Scale [ Time Frame: Week 14, Week 28 ]

Central Contacts

• Laura Sudec, Masters
  1-847-491-3183
  [email protected]

Locations (1)

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