Enhancing early language development in infants through caregiver interaction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine if the Talk With Me Baby (TWMB) program can improve the home-language environment for at-risk families with infants aged two to six months. Caregivers will receive the TWMB program during routine well-child checkups and will be encouraged to increase their verbal interactions with their infants. Participants will record their conversations with their infants before and after the program to assess changes in caregiver talk time. The study seeks to enhance language development by fostering more engaging communication between caregivers and infants.

Why it matters

Who can join: the full rules

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).

Where it's running

• Kansas University Medical Center
  Kansas City, Kansas, United States Recruiting
• West Virginia University
  Morgantown, West Virginia, United States Not yet recruiting

Study contacts

• Study coordinator: Song Ounpraseuth, PhD
• Email: STOunpraseuth@uams.edu
• Phone: 501-686-7233

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.