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

Northwestern University

Status: Begins enrollment this month

Conditions: Developmental Delays

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07227974

BPS-2024C1-38924

Details and patient eligibility

About

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.

Full 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:

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 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.

Enrollment: 1,269 estimated patients

Sex: All

Ages: 12 to 28 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Child Inclusion Criteria:

• Age at enrollment: Older than 12 months and younger than 28 months
• 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

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,269 participants in 3 patient groups

Therapist-Delivered Early Intervention Approach

Active Comparator group

Description:

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

Treatment:

Behavioral: Therapist-Delivered Early Intervention Approach

Caregiver Coaching Early Intervention Approach

Experimental group

Description:

For 28 weeks, this arm will receive the caregiver coaching early intervention approach.

Treatment:

Behavioral: Caregiver Coaching Early Intervention Approach

Combined Early Intervention Approach + Parents Taking Action

Experimental group

Description:

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.

Treatment:

Behavioral: Caregiver Coaching Early Intervention Approach

Behavioral: Parents Taking Action

Behavioral: Therapist-Delivered Early Intervention Approach