NCT07132411 · University of Kansas Medical Center
Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment
(TWMB)
What this study is about
Language-rich interactions with a parent or caregiver can serve as a protective factor for young children, by supporting their language development and other positive long-term outcomes, but existing interventions have not had the necessary reach to families who need this information the most.
View original scientific description
Language-rich interactions with a parent or caregiver can serve as a protective factor for young children, by supporting their language development and other positive long-term outcomes, but existing interventions have not had the necessary reach to families who need this information the most. This study utilizes the primary care setting as a low cost, scalable way to deliver language promotion intervention. Specifically, we will test the effectiveness and explore implementation of language promotion intervention (Talk With Me Baby) that embeds within anticipatory guidance during pediatric well-child care to boost early language development and optimize health, academic, and economic outcomes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Atlanta, Georgia
- Kansas City, Kansas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 24, 2026 · Source of record for eligibility and locations