Talk With Me Baby to Enhance the Early Home Language Environment
NCT06479278 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2025-08-29
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.
Conditions
- Language Development
- Speech
- Infant Development
- Infant Behavior
- Language, Child
- Language
Interventions
- BEHAVIORAL
-
Talk with Me Baby
Primary care providers will embed Talk With Me Baby (TWMB) within standard-of-care Well-Child Care visits for children ≤36 months of age. Children will receive usual care plus a brief language-promotion intervention (TWMB) in up to 4 consecutive Well-Child Care visits during their 12-month period.
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
University of Kansas
collaborator OTHER -
IDeA States Pediatric Clinical Trials Network
lead NETWORK
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 0 Months
- Max Age
- 9 Months
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-02-03
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
Countries
- United States
Study Locations
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