Recruiting

Early Intervention

Sponsor:

Northwestern University

Code:

NCT07227974

Conditions

Developmental Delays

Eligibility Criteria

Sex: All

Age: 1 - 2

Healthy Volunteers: Not accepted

Interventions

Therapist-Delivered Early Intervention Approach

Caregiver Coaching Early Intervention Approach

Parents Taking Action

Study Details

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. 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.

Conditions

Developmental Delays

Study ID

NCT07227974

Start date

Feb 16, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 2

Healthy Volunteers: Not accepted

Child Inclusion Criteria:

  • 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

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

Study Design

Enrollment

1269 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Responsive Strategy Use (RSU) Rating Scale [ Time Frame: Week 14, Week 28 ]
  • Family Outcomes Survey - Revised [ Time Frame: Week 14, Week 28 ]
  • Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP) [ Time Frame: Week 28 ]

Central Contacts and Locations

Central contacts

Laura Sudec, Masters

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

Locations

Northwestern University

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Laura Sudec, Masters

laura.sudec@northwestern.edu

Principal Investigator:

Megan Roberts, PhD

More Information

Sponsor

Northwestern University

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-07-08.