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
2 other identifiers
interventional
66
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2024
CompletedFirst Posted
Study publicly available on registry
June 28, 2024
CompletedStudy Start
First participant enrolled
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
August 29, 2025
July 1, 2025
1.6 years
June 18, 2024
August 27, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Talk With Me Baby
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IDeA States Pediatric Clinical Trials Networklead
- National Institutes of Health (NIH)collaborator
- University of Kansascollaborator
Study Sites (2)
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2024
First Posted
June 28, 2024
Study Start
February 3, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
August 29, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF
- Time Frame
- Per data sharing polices of NIH and the ISPCTN
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).