RecruitingNot ApplicableNCT06479278

Talk With Me Baby to Enhance the Early Home Language Environment

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


Sponsor

IDeA States Pediatric Clinical Trials Network

Enrollment

66 participants

Start Date

Feb 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 0 MonthsMax Age: 9 Months

Inclusion Criteria11

  • 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).

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Interventions

BEHAVIORALTalk 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.


Locations(2)

Kansas University Medical Center

Kansas City, Kansas, United States

West Virginia University

Morgantown, West Virginia, United States

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NCT06479278


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