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NCT Number: NCT06479278

Talk With Me Baby to Enhance the Early Home Language Environment

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.

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Key information

Conditions

Language Development Behavior Child Behavior Communication Infant Behavior Infant Development Language Language, Child Speech Verbal Behavior

Age range

0 month–9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kansas University Medical Center, Kansas City, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For this study, each child-caregiver dyad will consist of:

  • A caregiver who will receive TWMB during routine WCC visits for their child at participating clinics, and
  • 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:

  • Be the age of majority, or older, as defined by the state of residency.
  • Able to complete study measures in English.
  • 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:

  • Receive WCC at a participating clinic from a participating provider.
  • Be zero to nine months (+ 0-30 days) old at enrollment.
  • Was born at full term (> 37 weeks gestation).
  • Was born in a singleton birth (i.e., was the only child delivered during the birth).

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. Improvement in the home-language-environment promotion behaviors, as measured by the Language Environment Analysis (LENA) Adult Word Count percentile score from Baseline to Post-Intervention

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

DeAnn E Hubberd, MA

CONTACT

[email protected]

501-686-5547

Song Ounpraseuth, PhD

CONTACT

[email protected]

501-686-7233

Sponsors and collaborators

Lead sponsor

IDeA States Pediatric Clinical Trials Network

Network

Collaborators

  • National Institutes of Health (NIH)
  • University of Kansas

Registry information

Official study title

Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment for Rural and Underserved Children

Acronym: TWMB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2024
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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