Talk With Me Baby to Enhance the Early Home Language Environment

Description

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.

Conditions

Language Development, Speech, Infant Development, Infant Behavior, Language, Child, Language

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Study Overview

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Study Details

Study overview

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.

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

Talk With Me Baby to Enhance the Early Home Language Environment

Condition
Language Development
Intervention / Treatment

-

Contacts and Locations

Kansas City

Kansas University Medical Center, Kansas City, Kansas, United States, 66160

Morgantown

West Virginia University, Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. A caregiver who will receive TWMB during routine well-childcare checkups (WCC) visits for their child at participating clinics and
  • 2. The child of the above caregiver for whom the WCC visits are conducted.
  • 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.
  • 1. Receive WCC at a participating clinic from a participating provider.
  • 2. Be two to six 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).
  • 1. Has a cognitive impairment or a visual or hearing impairment known to the clinic that limits their ability to make decisions about participating or engaging with the assessments, based on the site primary investigator's (PI's) assessment and local human subjects' research policies.
  • 2. Does not live with child or spend at least two full days (i.e., at least 48 hours) per week with the child.
  • 3. Does not plan for the child to continue receiving services at the participating clinic for at least 12 months.
  • 1. Significant developmental delay or cognitive, visual, or hearing impairment known to the clinic.
  • 2. Previously attended WCC visit prior to enrollment that occurred during the TWMB trial.

Ages Eligible for Study

2 Months to 6 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

IDeA States Pediatric Clinical Trials Network,

Study Record Dates

2026-12