An interventional study of Talk with Me Baby in Language Development, Speech and Infant Development, sponsored by IDeA States Pediatric Clinical Trials Network. Recruiting at 2 sites in United States. Open to participants aged 0 Months to 9 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by IDeA States Pediatric Clinical Trials Network · Not applicable, Interventional, and Prevention
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:
205 studies on the registry are indexed under Speech; 80 are open to participants now.
This study's planned enrollment of 66 is above the median of 52 across 141 interventional studies indexed under Speech.
Browse Speech studies →IDeA States Pediatric Clinical Trials Network is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
For this study, each child-caregiver dyad will consist of:
A potential caregiver participant must meet all the following inclusion criteria to enroll in the study:
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:
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.
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
Plan to share: Yes — 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).
Supporting information: Statistical analysis plan, Informed consent form
Time frame: Per data sharing polices of NIH and the ISPCTN
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IDeA States Pediatric Clinical Trials Network