An interventional study of Therapist-Delivered Early Intervention Approach and Caregiver Coaching Early Intervention Approach in Developmental Delays, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to participants aged 12 Months to 32 Months. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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:
The goal of this study is to identify which approaches are most effective so that all families can benefit fully from EI services.
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:
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.
230 studies on the registry are indexed under Developmental Disabilities; 65 are open to participants now.
This study's planned enrollment of 1,269 is above the median of 60 across 150 interventional studies indexed under Developmental Disabilities.
Browse Developmental Disabilities studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 21, 2026. See what changed
Child Inclusion Criteria:
Child Exclusion Criteria:
- Exposed to a language other than English or Spanish more than 10% of the time
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria
For 28 weeks, this arm will receive the therapist-delivered early intervention approach.
Behavioral: Therapist-Delivered Early Intervention Approach
For 28 weeks, this arm will receive the caregiver coaching early intervention approach.
Behavioral: Caregiver Coaching Early Intervention Approach
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
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.
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 (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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 28
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%).
Time frame: 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.
Time frame: 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).
Time frame: Week 1 to Week 28
Early Intervention Program Satisfaction Scale
An adapted version of the Early Intervention Program Satisfaction Scale, a caregiver-report questionnaire, will be used to assess caregiver satisfaction. This survey includes 6 items rated on a 5-point Likert (1 = Very Dissatisfied, 5 = Very Satisfied). The Total Score (Min = 6, Max = 30) reflects caregivers' overall satisfaction with the intervention, with higher scores representing greater satisfaction.
Time frame: Week 14, Week 28
Plan to share: 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.
Supporting information: 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.
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Mar 2030, 49 months after the start.
Of 96 non-industry interventional studies with no phase under Developmental Disabilities, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 49. This study's planned 49 months is above that.
Counting every sponsor, half of 97 studies reached it within 22 months; a quarter within 13 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.