NCT06479278 Talk With Me Baby to Enhance the Early Home Language Environment
| NCT ID | NCT06479278 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IDeA States Pediatric Clinical Trials Network |
| Condition | Language Development |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2025-02-03 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is: Will the TWMB program increase the time a caregiver talks to their infant? Participants will: 1. Come to at least four well-child checkups 2. Receive the TWMB program from the provider during the checkups 3. Record their conversations with their infant before they receive the program and after they receive the program four times.
Eligibility Criteria
Inclusion Criteria: For this study, each child-caregiver dyad will consist of: 1. A caregiver who will receive TWMB during routine WCC visits for their child at participating clinics, and 2. The child of the above caregiver for whom the WCC visits are conducted. A potential caregiver participant must meet all the following inclusion criteria to enroll in the study: 1. Be the age of majority, or older, as defined by the state of residency. 2. Able to complete study measures in English. 3. Have the legal authority to consent to participate for themselves and to consent on behalf of their child. To proceed to the follow-up portion of the study the caregiver (dyad) must have a LENA baseline assessment score that is ≤ 75th percentile compared to a child's age-referenced normative data. A potential child participant must meet all the following inclusion criteria to be enrolled in the study: 1. Receive WCC at a participating clinic from a participating provider. 2. Be zero to nine months (+ 0-30 days) old at enrollment. 3. Was born at full term (\> 37 weeks gestation). 4. Was born in a singleton birth (i.e., was the only child delivered during the birth).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06479278 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 9 Months, studying Language Development. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06479278 currently recruiting?
Yes, NCT06479278 is actively recruiting participants. Contact the research team at STOunpraseuth@uams.edu for enrollment information.
Where is the NCT06479278 trial being conducted?
This trial is being conducted at Kansas City, United States, Morgantown, United States.
Who is sponsoring the NCT06479278 clinical trial?
NCT06479278 is sponsored by IDeA States Pediatric Clinical Trials Network. The trial plans to enroll 66 participants.