Talk With Me Baby to Enhance the Early Home Language Environment

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
IDeA States Pediatric Clinical Trials Network
Study ID
NCT06479278
Status
Recruiting
Apply to this trial

Conditions

  • Infant Behavior
  • Infant Development
  • Language
  • Language Development
  • Language, Child
  • Speech

Eligibility Criteria

Sex
ALL
Age
0 Months - 9 Months
Healthy Volunteers
Accepted

Interventions

  • Talk with Me Baby — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 3, 2025
Status verified
Jul 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Talk With Me Baby

Primary Outcome Measure

Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Conversational Turn Count percentile score from Baseline to Post-Intervention [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Kansas University Medical CenterKansas CityKansas66160
Brenda Salley, PhD
[email protected]
913-945-7944
West Virginia UniversityMorgantownWest Virginia26506
David Huss, MD
[email protected]
304-293-7331
Margaret Jaynes, MD
[email protected]
304-293-7331

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By research site
Kansas University Medical Center· Kansas City, KSWest Virginia University· Morgantown, WV

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