Talk With Me Baby to Enhance the Early Home Language Environment (TWMB)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infant Behavior; Infant Development; Language Development; Language; Language, Child; Speech
• Intervention / Treatment: Behavioral: Talk with Me Baby

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Song Ounpraseuth, PhD; Phone Number: 501-686-7233; Email: STOunpraseuth@uams.edu
• Study Contact Backup: Name: DeAnn E Hubberd, MA; Phone Number: 501-686-5547; Email: dehubberd@uams.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • Kansas University Medical Center
      • Contact: Brenda Salley, PhD; Phone Number: 913-945-7944; Email: bsalley@kumc.edu
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Not yet recruiting
      • West Virginia University
      • Contact: David Huss, MD; Phone Number: 304-293-7331; Email: david.huss@hsc.wvu.edu
      • Contact: Margaret Jaynes, MD; Phone Number: 304-293-7331; Email: mjaynes@hsc.wvu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Talk With Me Baby	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	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	12 months

Collaborators and Investigators

• Sponsor: IDeA States Pediatric Clinical Trials Network
• Collaborators: National Institutes of Health (NIH); University of Kansas

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Communication; Child Behavior; Verbal Behavior; Speech; Infant Behavior; Language
• Other Study ID Numbers: 276453; U24OD024957 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Investigators will conduct this trial following the publication and data-sharing policies and regulations listed below:

NIH Public Access Policy requires scientists to submit final peer-reviewed journal manuscripts arising from NIH funds to the digital archive PubMed Central upon acceptance for publication.

Environmental Influences on Child Health Outcomes (ECHO) IDeA States Pediatric Clinical Trials Network (ISPCTN) Publications and Presentations Policy ensures the accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials.

NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Resulting Information Submission Rule. Other researchers may request data from this trial by contacting Song Ounpraseuth, Ph.D., at the ISPCTN Data Coordinating and Operations Center (DCOC).

• IPD Sharing Time Frame: Per data sharing polices of NIH and the ISPCTN
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No