Talk With Me Baby to Enhance the Early Home Language Environment

Official title

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

Overview

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.

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.

Primary outcome measures

• 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]
• 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 2 centers

• Kansas University Medical Center — Kansas City
• West Virginia University — Morgantown

Publications

• Salley B, Jaynes M, Huss D, Foster K, Hubberd D, Pohl K, Adkison S, Nader P, Baldner J, Greer M, Jin J, Fu LY, Abraham P, Ellerbeck EF. Study protocol for a pilot evaluation of Talk With Me Baby (TWMB) for Well-Child Care: A primary care-integrated language promotion intervention in rural and underserved clinics. PLoS One. 2026 Jul 24;21(7):e0353423. doi: 10.1371/journal.pone.0353423. eCollection PMID 42497176

Identifiers

NCT: NCT06479278 · 276453 · U24OD024957

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗