Clinical trial Recruiting at 1 site Interventional Ages 1 Day to 2

Talk With Me Baby — boosting early home language during well-child visits

Official title: Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment

Run by University of Kansas Medical Center · NCT07132411 · Data updated 2026-11-12

This program tests whether adding brief, evidence-based language coaching into routine well-child visits helps infants and toddlers (0–3 years) and their caregivers build richer home language environments.

More Language Delay trials

Quick facts

Study typeInterventional
Ages1 Day to 2 Years
SexAll
Enrollment400 (estimated)
SponsorUniversity of Kansas Medical Center
Academic / other
Locations2 sites (Atlanta, Georgia and 1 other locations)
StatusRecruiting
StartedFebruary 5, 2026
Main results expectedMarch 2029
Study endsJune 2029
Registry record updatedMarch 24, 2026
Trial IDNCT07132411 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are full-term singleton infants enrolled before their 2-month well-child visit (around 1 month old), from English- or Spanish-speaking homes, who receive ongoing well-child care at a participating clinic.

Probably not a fit

Children with severe congenital disorders affecting neurodevelopment or significant hearing impairment, families not living with or spending at least two days per week with the caregiver, or those who do not continue care at a participating clinic are unlikely to benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Talk With Me Baby embeds brief, evidence-based language-promotion guidance into pediatric well-child care to increase caregiver-child language interactions. This randomized, controlled, type 1 hybrid effectiveness-implementation trial compares 8 clinics delivering the TWMB intervention with 8 care-as-usual clinics across two sites (Emory University and University of Kansas Medical Center). Providers in intervention clinics will be trained to deliver TWMB during anticipatory guidance at routine visits for children 0–36 months, and researchers will measure changes in the home language environment and subsequent child language outcomes. The study also collects implementation data on feasibility, reach, and barriers to scaling TWMB in primary care.

Why it matters

Potential benefit: If successful, the program could provide low-cost, scalable language support during routine pediatric visits that improves early language skills and long-term academic and health outcomes.

How similar studies have gone: TWMB builds on decades of well-controlled language-intervention trials and has been used clinically for over eight years, though embedding it at primary-care scale is a more recent effort.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria for Participants:

* Child must be enrolled prior to attending their 2-month WCC visit, age 1 month (+/- 30 days)
* Full term (\>=37 weeks gestation)
* Singleton birth
* Home language of English and/or Spanish
* Child must receive WCC at a participating clinic

Exclusion Criteria for Participants:

* Child with a severe congenital disorder that would affect neurodevelopmental outcomes, or hearing impairment that could affect participation
* Parent does not live with or spend \>=2 days/week with the child
* Family does not plan to continue services at the clinic

Inclusion Criteria for Clinics:

* A primary care practice (family medicine or pediatric model) that delivers WCC for children from 0-36 months old
* A minimum of 30% Medicaid/uninsured visits/year
* A minimum of 300 unique 0 to 36-month-old patients/year

Where it's running

  • University of Kansas Medical Center
    Kansas City, Kansas, United States
    Recruiting
  • Emory University
    Atlanta, Georgia, United States
    Not yet recruiting

Study contacts

  • Principal investigator: Brenda J Salley, PhD — University of Kansas Medical Center
  • Study coordinator: Brenda J Salley, PhD
  • Email: bsalley@kumc.edu
  • Phone: 913-945-7944

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.