Talk With Me Baby — boosting early home language during well-child visits
Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 1 Day to 2 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT07132411 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Atlanta, Georgia and 1 other locations
- Emory University — Atlanta, Georgia, United States (Not_yet_recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.